Neoplasms

Nervous System Diseases

All Conditions

Symptoms and General Pathology

Brain Neoplasms

Epilepsy

Seizures

Brain Diseases

Central Nervous System Diseases

Central Nervous System Neoplasms

Nervous System Neoplasms

Patients who have solitary primary or recurrent brain tumor with associated seizures.

Gretchen C Scott, R.N.

Kareem A Zaghloul, M.D.

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Background:

Some people with brain tumors have seizures related to the tumor. This is called tumor-related epilepsy. Usually brain tumors are treated by removing as much of the brain tumor as possible without causing problems. Researchers think this may improve the outcome for people with brain tumors. It may completely relieve or greatly reduce the number of seizures they have.

Objectives:

To evaluate people with brain tumors that are associated with seizures and to offer surgical treatment. Also, to study how surgery affects seizures.

Eligibility:

People age 8 and older who have a brain tumor with associated seizures. They must be willing to have brain surgery to treat their epilepsy.

Design:

Participants will be screened with a review of their medical records.

Participants will have a medical history and physical exam.

Participants will be admitted to the hospital at NIH. They will have

Medical history

Physical exam

Neurological exam

Tests of memory, attention, and thinking

Questions about their symptoms and quality of life

Blood drawn

They may also have:

MRI or CT scan. They will lie on a table that slides in and out of a machine that takes pictures. For part of the MRI, they will get a dye through an intravenous (IV) catheter.

Video electroencephalography monitoring. Electrodes will be placed on the scalp. The participant s brain waves will be recorded while doing normal activities. Participants will be videotaped.

Participants will keep a seizure diary before and after surgery.

Participants will have surgery to remove their brain tumor and the brain area where their seizures start.

They will stay in the hospital up to a week after surgery.

Participants have for follow-up visits at NIH.

Objective

This protocol is being performed to 1) study the natural history and disease pathogenesis in patients with tumor related epilepsy, 2) collect prospective data on seizure outcomes following standard surgical treatment of brain tumors with associated seizures2, 3) follow the clinical course of patients after surgical resection of brain tumors with associated seizures, such as outcomes in seizure activity as they relate to type of tumor and extent of resection, 4) investigate neuropsychological and cognitive outcomes as they relate to surgical and seizure outcomes, 5) evaluate patient reported outcomes such as symptom burden changes as a result of surgical resection in patients with tumor-related epilepsy, 6) examine changes in structural and, when available, functional imaging in the context of tumor related epilepsy before and after surgical resection, 8) investigate molecular markers of tumor-related seizures in tumor and peritumoral specimens and, when available, to compare them to electrophysiological markers of tumor-related seizure activity.

Study Population

Patients 8 years and older with brain tumors and associated seizures may participate in this study.

Study Design

Patients will be screened by study neurosurgeon or neuro-oncologists to verify their confirmed or likely diagnosis of brain tumor and associated seizures. Patients confirmed to have a brain tumor with associated seizures will be offered standard diagnostic and surgical procedures. Non-invasive diagnostic procedures include structural MRI and neuropsychological, cognitive, and outcome assessments which may be performed under other NIH protocols. Some patients may receive functional MRI when clinically indicated, which will be performed under separate NIH protocols. Prior to tumor resection, diagnostic invasive monitoring with intracranial electrodes for further localization of seizure focus and identification of eloquent cortex may be clinically required. In these cases, invasive monitoring will be performed under a separate protocol, 11-N-0051 Epilepsy Surgery. Patients will be followed for three-six months after the surgical procedure to collect prospective data on seizure outcomes following standard surgical treatment of brain

tumors with associated seizures. Patients may also be seen at one year following surgery if medically stable and healthy. Participants in this protocol will not forego other standard treatments for their brain tumor, including chemotherapy and radiation treatment. Participation in this protocol will not preclude eligibility or participation in other NIH clinical trials.

Outcome Measures

The primary outcome measure is the change in seizure frequency, as measured by the Engel scale before and 3-6 months after treatment. Secondary outcome measures include 1) mean Engel Class and absolute and relative change in seizure frequency three-six months after surgery stratified by the type of brain tumor and location and Engel scale, seizure frequency, and mean Engel Class and absolute and relative change in seizure frequency one year after surgery stratified by the type of brain tumor and location; 2) extent of tumor and peri-tumoral resection as seen on MRI imaging and correlation with seizure outcome; 3) changes in neuropsychological and cognitive assessment following surgical resection stratified by location and type of tumor and extent of resection; 4) longitudinal changes in symptom burden and interference scores using established instruments in brain tumor patients; 5) changes in structural imaging following surgical resection; 6) change in the use of anti-epileptic medication; and 7) percentage of patients with permanent neurological side-effects from surgical treatment.

Tumor Related Epilepsy

.We do plan to share IPD. We will share all IPD that results in a publication on a public repository, as required by most journals. The data will be de-identified and anonymized.

The primary outcome measure is the Engel scale of patients 3-6 months after treatment. Engel s classification: Class I: patients who were completely seizure free, had auras only, or had convulsions with drug withdrawal only; Class II: rare disabling seizures or nocturnal seizures only; Class III: worthwhile improvement (frequent seizures but fewer than previously); Class IV: no improvement (frequent seizures with unchanged frequency compared to before surgery). Seizure frequency before and after surgical resection will be documented to determine Engel classification.

Mean Engel Class three to six months after surgery stratified by the type of brain tumor and location and Engel scale, seizure frequency, and mean Engel Class one year after surgery stratified by the type of brain tumor and location

Extent of tumor resection as seen on MRI imaging and correlation with seizure outcome

Changes in neuropsychological and cognitive assessment following surgical resection stratified by location and type of tumor and extent of resection

Changes in symptom burden and interference with daily activities and quality of life

Changes in structural imaging following surgical resection

Percentage of patients who are able to be completely withdrawn from anti-epileptic medication

Percentage of patients with permanent neurological side-effects from surgical treatment.

National Institute of Neurological Disorders and Stroke (NINDS)

Rare Diseases

Drug Resistant Epilepsy

Glioma

Epilepsies, Partial

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neurologic Manifestations

Neuroepithelioma

Anticonvulsants

All Drugs and Chemicals

Patients receive perampanel PO QD for 40 weeks in the absence of disease progression or unacceptable toxicity.

Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity.

Anticonvulsant Agent

Perampanel

Quality-of-Life Assessment

Questionnaire Administration

William Tatum

This phase IV trial studies the side effects and how well perampanel works in reducing seizure frequency in patients with high-grade glioma and focal epilepsy. Perampanel is a drug used to treat seizures. Giving perampanel together with other anti-seizure drugs may work better in reducing seizure frequency in patients with high-grade glioma and focal epilepsy compared to alternate anti-seizure drugs alone.

PRIMARY OBJECTIVE:

I. Demonstrate the efficacy and safety of perampanel (PER) on seizure frequency in adult patients with biopsy-proven high-grade glioma and focal epilepsy compared with alternate anti-seizure drugs (ASDs).

SECONDARY OBJECTIVES:

I. To assess the change in neurocognitive function and brain magnetic resonance imaging (MRI) progression over the course of PER treatment with a daily dose of 4 mg (up to -8mg) in patients with biopsy-proven high-grade glioma and focal epilepsy compared with alternate ASDs.

II. To identify a biomarker-specific response to seizure-reduction in patients treated with PER in patients with a biopsy-proven high-grade glioma (i.e., IDH-mutant versus \[vs\] wildtype).

OUTLINE: Patients are assigned to 1 of 2 groups.

GROUP A: Patients receive perampanel orally (PO) once daily (QD) for 40 weeks in the absence of disease progression or unacceptable toxicity.

GROUP B: Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up for 12 months.

Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy

A Phase IV, Prospective, Open-Label, Parallel Study Evaluating the Effect of an Adjunctive Anti-Seizure Medication Using a Glutamatergic Modulator in Patients With Focal Epilepsy and High-Grade Glioma

Will compare seizure frequency before and 3 months after treatment with monotherapy and adjunctive PER and use descriptive statistics to demonstrate differences in responders. A P-value \< 0.05 will be used to reflect statistical significance.

Will compare seizure frequency before and 6 months after treatment with monotherapy and adjunctive PER and use descriptive statistics to demonstrate differences in responders. A P-value \< 0.05 will be used to reflect statistical significance.

Chi-square and Student T-test will be used to measure differences in assessment and change during the study period.

Mayo Clinic

Principal Investigator

Patients receive perampanel PO QD for 40 weeks in the absence of disease progression or unacceptable toxicity.

Perampanel: Given PO

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Arm A (Perampanel)

Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity.

Anticonvulsant Agent: Given ASD

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Arm B (ASD)

Total

Age, Categorical

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Study was terminated due to the funding sponsor(EISAI) sold the US rights to the medication and can no longer provide it to patients for the study.

William Tatum, D.O.

1 participant was randomized to Arm B, but did not complete the 3 month follow-up due to study termination. In Arm A, only 2 participants met the study 3 month mark prior to study termination.

Number of Patients With a High-grade Glioma Who Achieve a > 50% Reduction in Focal Seizures With Perampanel (PER) 4 mg Daily After Failing 1 or More Anti-seizure Drugs (ASDs)

1 participant was randomized to Arm B, but did not complete the 6 month follow-up due to study termination. In Arm A, only 1 participant met the study 6 month mark prior to study termination.

Number of Patients With a High-grade Glioma Who Achieve a > 50% Reduction in Focal Seizures With PER 4 mg Daily After Failing 1 or More ASDs

1 participant was randomized to Arm B, but did not receive PER treatment. In Arm A, only 2 participants met the study 3 month mark prior to study termination.

Number of Participants Alive at 3 Months With High-grade Glioma Treated With PER

The study was terminated due to the funding sponsor no longer being able to provide study medication. Data for this outcome measure was not collected nor analyzed.

Decline in Neuropsychological Function

Overall Study

Immune System Diseases

Infections

Autoimmune Diseases

Encephalitis

Limbic Encephalitis

Autoimmune Diseases of the Nervous System

Neuroinflammatory Diseases

Virus Diseases

Central Nervous System Viral Diseases

Communicable Diseases

Central Nervous System Infections

Syndrome

Paraneoplastic Syndromes

Paraneoplastic Syndromes, Nervous System

Neurodegenerative Diseases

Autoantibodies

Antibodies

Immunoglobulins

Immunoglobulins, Intravenous

Immunologic Factors

IVIG 2 mg/kg in two divided doses with placebo crossover

IVIG

Charles M. Epstein, M.D.

The purpose of the initial screening study is to find out if immune problems are an unrecognized cause of epilepsy in some patients. This study consists of a single blood sample, which will be tested for possible immune abnormalities. If enough patients are found who show immune abnormalities, those patients who are still having uncontrolled seizures will be invited to participate in a study of immune treatment with a compound called intravenous immunoglobulin (IVIG).

The study hypothesis is that a significant proportion of the young-onset, refractory, image-negative, partial-onset epilepsy population have an underlying autoimmune disorder, and many of these patients will respond to immune therapies, including IVIG.

At present, the importance of immune abnormalities in causing epilepsy, and the proper treatment when they are found, are both poorly understood. The investigators hope that this study will help us understand the cause of some cases that are difficult to treat.

The study is divided into two phases:

Phase I: The investigators will screen for evidence of neuronal nuclear, cytoplasmic, and cell surface autoantibodies in our population of new onset refractory, imaging-negative young adult epilepsy patients. This part of the study involves obtaining a single blood sample, equal to about 2 teaspoons.

Phase 2: If a sufficient number of cases are identified, a double-blind crossover study of IVIG treatment will be performed in these patients.

IVIG Treatment for Refractory Immune-Related Adult Epilepsy

neuronal nuclear, cytoplasmic, and cell surface autoantibodies

Baxter Healthcare Corporation

Emory University

Professsor of Neurology - Divsion of Epilepsy

IVIG

IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover

No AE's.

All Subjects

IVIG

IVIG: IVIG 2 mg/kg in two divided doses with placebo crossover

Study was terminated early. Subject eligibility for phase 2 not available.

Dr. Charles M. Epstein

No analysis occurred and study was terminated early due to subject numbers not eligible for the 2nd phase of the study.

Immune Abnormalities

Diseases and Abnormalities at or Before Birth

Skin and Connective Tissue Diseases

Headache

Congenital Abnormalities

Abdominal Neoplasms

Hydrocephalus

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Nerve Sheath Neoplasms

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Genetic Diseases, Inborn

Neurofibromatosis

Neurofibromatosis Type 1

Analgesics

Central Nervous System Depressants

Anti-Arrhythmia Agents

Channel Blockers

Pharmaceutical Solutions

Platelet Aggregation Inhibitors

Adjuvants, Anesthesia

Dexmedetomidine

Lidocaine

Nitrous Oxide

Propofol

Sevoflurane

Glycopyrrolate

Anesthetics

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Hypnotics and Sedatives

Analgesics, Non-Narcotic

Adrenergic Agents

Adrenergic alpha-Agonists

Adrenergic Agonists

Neurotransmitter Agents

Anesthetics, Intravenous

Anesthetics, General

Anesthetics, Inhalation

Muscarinic Antagonists

Cholinergic Antagonists

Cholinergic Agents

Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions.

Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions.

propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists

propofol

single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg

4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group

1 mg/kg intravenous administration prior to propofol administration

Lidocaine 1% Injectable Solution

Inhalation of nitrous oxide may be used for IV placement

Inhalation of sevoflurane may be used for IV placement

Susan P Taylor, MD, MPH

The purpose of this study is to compare the results of combining two anesthetic medications (dexmedetomidine and propofol) in low doses with a standard dose of a single drug that is commonly used to provide sedation/anesthesia for MRI studies in young children (propofol).

The drugs used for the MRI scan in this study will be chosen randomly. Half the patients will receive small doses of propofol and dexmedetomidine. The other half will receive propofol administered constantly throughout the scan. Other drugs that may be used include sevoflurane and nitrous oxide at the start of the sedation (for placing an intravenous), lidocaine (to reduce the pain of propofol injection) and glycopyrrolate (to prevent the heart rate from decreasing too low. The investigators will record 5 additional blood pressures and heart rates. If additional medications are required to complete the scan, the investigators will administer whatever is necessary. At the end of the study, the investigators will have an observer record the time it takes for participants to spontaneously open eyes , to be able to drink liquids and/or eat and to behave as before the study. Also, it is very important that the investigators find out from participants about changes in behavior, or if eating or sleeping habits were unusual following completion of the study. For that reason, the investigators will call participants in a day or so following the MRI scan.

The investigators expect to recruit 40 children between the ages of 12 and 72 months for the study and hope to have the study completed in December 2018.

The purpose of this study is to compare the results of combining two anesthetic medications (dexmedetomidine and propofol) in low doses with a standard dose of a single drug that is commonly used to provide sedation/anesthesia for MRI studies in young children (propofol).

Recent studies and the FDA have raised concerns that anesthesia for longer than three hours may have effects on behavior and learning. Although investigators do not know if these effects are caused by drugs or the medical condition a child is being treated for, in December 2016, the FDA published the information below regarding anesthesia for children:

General anesthetic and sedation drugs are used to put people into a deep sleep so they do not feel pain during surgery or procedures.

These drugs are usually injected into a vein or breathed in through a mask. General anesthetic and sedation drugs are widely used to ensure the health, safety, and comfort of children and adults undergoing surgery or other procedures.

Recent studies in children suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning. More research is still needed to fully understand how anesthetics might affect brain development, especially longer or repeated exposures and in more vulnerable children. Anesthetic and sedation drugs are necessary for infants, children, and pregnant women who require surgery or other painful and stressful procedures. https://www.fda.gov/Drugs/DrugSafety/ucm532356.htm Research in neonatal and infant animals has demonstrated that sedative and anesthetic agents, like propofol, produce adverse effects on brain development, including loss of brain cells resulting in long-term, possibly permanent changes in learning and behavior. These adverse effects appear to occur mostly after prolonged periods of sedation or anesthesia (generally greater than 3 hours) and when brain development is occurring at a rapid rate (which roughly occurs in children under 3 years of age). It is not known if similar adverse effects occur in humans. Study participants should be advised that the drugs used to accomplish the procedure may have the potential to increase the loss of nerve cells in the developing brain of young child and that the clinical significance of any such changes is not known. There are some animal studies that suggests dexmedetomidine may be better for a growing infant's brain. However, the effects of dexmedetomidine alone or in combination with propofol on the developing brain have not been thoroughly tested to date." The drugs used for the MRI scan in this study will be chosen randomly. Half the patients will receive small doses of propofol and dexmedetomidine. The other half will receive propofol administered constantly throughout the scan. Other drugs that may be used include sevoflurane and nitrous oxide at the start of the sedation (for placing an intravenous), lidocaine (to reduce the pain of propofol injection) and glycopyrrolate (to prevent the heart rate from decreasing too low. Investigators will record 5 additional blood pressures and heart rates. If additional medications are required to complete the scan, investigators will administer whatever is necessary. At the end of the study, an observer will record the time it takes for spontaneous eye opening, to be able to drink liquids and/or eat and to behave as before the study. Also, it is very important that investigators learn in the following day or two how the participant behaved at home; whether eating, behavior and sleeping were unusual. For that reason, the investigator will call the participant a day or so following the MRI scan.

The investigators expect to recruit 70 children between the ages of 12 and 72 months for the study and hope to have the study completed in 2018.

observer blinded comparison of propofol with low-dose propofol and dexmedetomidine for pediatric MRI sedation

The patients and their parents/guardians as well as the blinded observer or investigator who participates in outcomes assessment will be blinded to the drug or drugs administered.

Dexmedetomidine and Propofol for Pediatric MRI Sedation

An Observer-blinded Randomized Study of Propofol Infusion vs Bolus Dexmedetomidine and Propofol Sedation for Pediatric Magnetic Resonance Imaging

Time (minutes) from anesthesia start to readiness for discharge from the department to home or clinic.

minutes from completion of scan to spontaneous eye opening

minutes from completion of scan to oral/enteral intake

minutes from completion of scan to discharge ready

parental observation of deviation from child's normal habit obtained through follow-up phone call

behavior deemed inappropriate and a deviation from child's normal though parental observation obtained through follow-up phone call

Pediatric Anesthesia Emergence Delirium (PAED) score greater than 12 as defined by Sikich and Lerman. 0 = no delirium, 20 = worst possible delirium; 5 categories scored from 0-4 additive for a maximum score of 20. Categories 1-3 are scored the same and categories ar scored inversely as described. 1. Child makes contact with caregiver, 2. child's actions are purposeful, 3. child is aware of his surroundings. For each of these category, score 0 for extremely, 1 for very much, 2 for quite a bit, 3 for just a little, 4 for not at all. The other 2 categories 4. Child is restless and 5 Child is inconsolable are scored as 0 for not at all, 1 for just a little, 2 for quite a bit, 3 for very much, 4 for extremely

Medical College of Wisconsin

Associate Professor, Department of Pediatric Anesthesiology

Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions.

propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists

Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions.

propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists

Dexmedetomidine: single dose dexmedetomidine administered at start of sedation. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mic/kg

Propofol Dexmedetomidine

Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mic/kg/min. Dose will be increased by 50 mic/kg/min up to 300 mic/kg/min for movement and decreased to 150 mic/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions.

propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists

Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mic/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mic/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mic/kg/min. Study to be terminated if movement persists despite above interventions.

propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists

Dexmedetomidine: single dose dexmedetomidine administered at start of sedation. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mic/kg

Age, Continuous

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Susan Taylor MD

Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mic/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions.

propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists

Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions.

propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists.

Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg.

Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tumor Related Epilepsy	NCT02639325	Epilepsy Cancer Brain Neoplasm		8 Years - 99 Years	National Institutes of Health Clinical Center (CC)
Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy	NCT04650204	Intractable Epi... Malignant Gliom... Seizure Disorde... WHO Grade 2 Gli... WHO Grade 3 Gli...	Anticonvulsant ... Perampanel Quality-of-Life... Questionnaire A...	18 Years -	Mayo Clinic
Tumor Related Epilepsy	NCT02639325	Epilepsy Cancer Brain Neoplasm		8 Years - 99 Years	National Institutes of Health Clinical Center (CC)
IVIG Treatment for Refractory Immune-Related Adult Epilepsy	NCT01545518	Epilepsy, Crypt... Epilepsy, Parti... Seizure Disorde... Autoimmune Dise... Limbic Encephal...	IVIG	18 Years - 50 Years	Emory University
Dexmedetomidine and Propofol for Pediatric MRI Sedation	NCT03513757	Headache Tumor Seizure Disorde... Neurofibromatos... Hydrocephalus Abdominal Neopl... Spine Deformity	propofol Dexmedetomidine Glycopyrrolate Lidocaine 1% In... Nitrous Oxide Sevoflurane	12 Months - 60 Months	Medical College of Wisconsin
Seizure Control as a New Metric in Assessing Efficacy of Tumor Treatment in Patients With Low Grade Glioma	NCT04553757	Brain Neoplasm Low Grade Gliom... Seizure Disorde...	Survey Administ...	-	M.D. Anderson Cancer Center
Dexmedetomidine and Propofol for Pediatric MRI Sedation	NCT03513757	Headache Tumor Seizure Disorde... Neurofibromatos... Hydrocephalus Abdominal Neopl... Spine Deformity	propofol Dexmedetomidine Glycopyrrolate Lidocaine 1% In... Nitrous Oxide Sevoflurane	12 Months - 60 Months	Medical College of Wisconsin
Seizure Control as a New Metric in Assessing Efficacy of Tumor Treatment in Patients With Low Grade Glioma	NCT04553757	Brain Neoplasm Low Grade Gliom... Seizure Disorde...	Survey Administ...	-	M.D. Anderson Cancer Center
Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy	NCT04650204	Intractable Epi... Malignant Gliom... Seizure Disorde... WHO Grade 2 Gli... WHO Grade 3 Gli...	Anticonvulsant ... Perampanel Quality-of-Life... Questionnaire A...	18 Years -	Mayo Clinic
Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy	NCT04650204	Intractable Epi... Malignant Gliom... Seizure Disorde... WHO Grade 2 Gli... WHO Grade 3 Gli...	Anticonvulsant ... Perampanel Quality-of-Life... Questionnaire A...	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for seizure disorder