Symptoms and General Pathology

All Conditions

Nervous System Diseases

Neoplasms

Heart and Blood Diseases

Behaviors and Mental Disorders

Immune System Diseases

Syndrome

Migraine Disorders

Brain Neoplasms

Parkinson Disease

Stroke

Cognitive Dysfunction

Epilepsy

Sclerosis

Multiple Sclerosis

Psychomotor Agitation

Restless Legs Syndrome

Autoimmune Diseases

Demyelinating Autoimmune Diseases, CNS

Autoimmune Diseases of the Nervous System

Demyelinating Diseases

Cognition Disorders

Neurocognitive Disorders

Mental Disorders

Psychotic Disorders

Parasomnias

Sleep Disorders, Intrinsic

Dyssomnias

Sleep Wake Disorders

Analgesics

Psychotropic Drugs

All Drugs and Chemicals

Platelet Aggregation Inhibitors

Anti-Arrhythmia Agents

Antihypertensive Agents

Vasodilator Agents

Anti-Inflammatory Agents

Antineoplastic Agents

Channel Blockers

Anticonvulsants

Central Nervous System Depressants

Antipyretics

Antirheumatic Agents

Fibrinolytic Agents

Nootropic Agents

Neuroprotective Agents

Anti-Dyskinesia Agents

Antiemetics

Gastrointestinal Agents

Hypoglycemic Agents

Vasoconstrictor Agents

Other Dietary Supplements

Duloxetine Hydrochloride

Clopidogrel

Propranolol

Prednisolone

Pregabalin

Aspirin

Amitriptyline

Donepezil

Levetiracetam

Rivastigmine

Valproic Acid

Pramipexole

Dexpramipexole

Methylprednisolone

Methylprednisolone Acetate

Methylprednisolone Hemisuccinate

Prednisolone acetate

Prednisolone hemisuccinate

Prednisolone phosphate

Topiramate

Memantine

Rotigotine

Lamotrigine

Zolmitriptan

Sumatriptan

Rizatriptan

Omega 3 Fatty Acid

The investigators will conduct 11 pragmatic trials using the EMR: brain tumors (prevent seizures), epilepsy (prevent other seizure types), mild cognitive impairment (improve memory), migraine (prevention), migraine (abortive), mild traumatic brain injury (prevent post concussion syndrome), multiple sclerosis (attenuate relapses), neuropathy (pain management), Parkinson's (treat motor symptoms), restless legs syndrome (treat sensory symptoms), stroke (secondary prevention). For each trial they will compare up to three medications or treatments either FDA approved for the indication, or commonly employed. The pragmatic trials will be small and primarily to demonstrate the feasibility of subgroup based adaptive assignment of treatments, electronic consenting, and data capture at the point of care using the EMR. The focus is on the development of the study design and methodology and not on the treatments per se.

brain tumors (lamotrigine, levetiracetam, valproic acid), epilepsy (lamotrigine, levetiracetam, valproic acid), mild cognitive impairment (donepezil, rivastigmine, memantine), migraine (amitriptyline, propranolol, topiramate), migraine (sumatriptan, rizatriptan, zolmitriptan), mild traumatic brain injury (omega-3 fatty acids, education only), multiple sclerosis (ACTH, methylprednisolone), neuropathy (duloxetine, pregabalin, amitryptiline), Parkinson's disease (pramipexole, ropinerole, rotigotine), restless legs syndrome (pramipexole, ropinerole, rotigotine), stroke (aspirin, clopidogrel).

Listed for each disorder below, up to three drugs per disorder (too many characters to list in this field; see Intervention Description)

The investigators will conduct at NorthShore University HealthSystem pragmatic trials using the EMR for 10 common neurological disorders. They will demonstrate the feasibility of subgroup based adaptive assignment of treatments, electronic consenting, and outcomes data capture at the point of care using the EMR. They will identify the most effective treatments for common neurological disorders and seek replication by the NPBRN.

The goals of the proposed research are to advance quality improvement and practice based research in Neurology using the electronic medical record (EMR). The American Academy of Neurology (AAN) has published evidence-based guidelines, quality improvement measures, and resources for several neurological disorders. However, the AAN guidelines and measures have not been implemented routinely and benchmark data are lacking. There are few EMR tools available to standardize neurology office visits according to Best Practices, to provide alerts when neurological care is deviating from AAN guidelines, to capture data regarding adherence to AAN or other quality parameters, to measure the effects of compliance with guidelines on outcomes, or to share longitudinal data and to compare effectiveness of care across neurological practices. The Department of Neurology at NorthShore University HealthSystem (NorthShore) has built into its commercial EMR "Epic" structured clinical documentation support (SCDS) and clinical decision support (CDS) tools that standardize care, write progress notes, and capture up to 1,000 discrete and cascading fields of neurological data per office visit. However, these EMR tools have not been disseminated for use by other Neurology practices or for data sharing, and presently do not support clinical trials. Pragmatic trials using EMRs would enable comparisons of treatments at the point of care. To address gaps in quality improvement and practice based research in Neurology, the investigators are proposing to the Agency for Healthcare Research and Quality (AHRQ) a project with the specific aims: 1) To create a Neurology Practice Based Research Network (NPBRN). The NorthShore site will share SCDS and CDS tools for 10 common neurological disorders (brain tumors, epilepsy, migraine, mild cognitive impairment, mild traumatic brain injury, multiple sclerosis, neuropathy, Parkinson's disease, restless legs syndrome, and stroke) with seven other Department of Neurology that also use the Epic EMR platform (eight sites total). 2) To conduct at NorthShore pragmatic trials using the EMR for 10 common neurological disorders. The investigators will demonstrate the feasibility of subgroup based adaptive assignment of treatments, electronic consenting, and outcomes data capture at the point of care using the EMR. They will identify the most effective treatments for common neurological disorders and seek replication by the NPBRN. The aims are innovative because the investigators will use the EMR to hardwire quality and outcomes research in Neurology. They will individualize medicine at the point of care by conducting pragmatic trials using subgroup based adaptive designs, comparing the effectiveness of available treatments for common neurological disorders. The aims are significant because they are studying several neurological disorders, a leading cause of healthcare burden worldwide. They will create a national practice based network to improve health care quality by accelerating implementation of patient-centered outcomes research in Neurology using the EMR, and evidence to make health care safer and to improve health care efficiency. NOTE: This ClinicalTrials.gov registration relates to Aim 2 of the project (pragmatic trials using the EMR). Aim 1 is an observational study only (quality improvement, comparative effectiveness research).

Quality Improvement and Practice Based Research in Neurology Using the EMR

Quality Improvement and Practice Based Research in Neurology Using the Electronic Medical Record

NorthShore University HealthSystem

Senior Clinician Educator, Department of Neurology

Skin and Connective Tissue Diseases

Headache

Ganglion Cysts

Synovial Cyst

Cysts

Pain

Neurologic Manifestations

Mucinoses

Connective Tissue Diseases

Pharmaceutical Solutions

Lidocaine

Anesthetics

Anesthetics, Local

Sodium Channel Blockers

Diuretics, Potassium Sparing

Participants will receive 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares.The portion of the procedure involving this device lasts approximately 30-60 seconds.

Lidocaine in SphenoCath device

Participants will receive saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasts approximately 30-60 seconds.

Saline Solution in SphenoCath device

Michael Popovich, MD

This clinical trial will enroll participants to evaluate the effects of SPG block on post-traumatic headache. The study hypothesizes that patients that receive a SPG block with lidocaine vs. placebo (saline) will have a lower number of headache days in the week following the procedure, and will also report lower symptom scores.

Eligible participants will receive one treatment (SPG block) as well as complete surveys prior to and after receiving treatment (for a total of approximately 2 weeks).

Sphenopalatine Ganglion Block for Headache After Concussion

A Phase II Randomized Controlled Double-Blind Clinical Trial of Sphenopalatine Ganglion (SPG) Block for Headache After Concussion

Upon request, I will share de-identified participant demographic information, outcome data, study protocol, statistical analysis plan, and informed consent form.

Patients will rate their headache on a scale of 0 to 6, with 0 corresponding to "absent" and 6 corresponding to "severe."

A rating scale of global improvement which participants use a seven-point scale ("1" = very much improved, "4" = no change, "7" very much worse). Participants will rate their change at two hours and 24 hours following the SPG block procedure.

The number of headache episodes over the one week prior to the SPG block compared to one week after the procedure.

The number of headache episodes prior to the SPG block to after the procedure.

The number of headache episodes over the one week prior to the SPG block to one week after the procedure.

The number hours with headache 1 week prior to the SPG block and for up to 1 week after the procedure.

Patients will be asked to report the number of uses of as-needed headache medications used in the one week prior to the SPG block and after SPG block for up to one week after the procedure.

University of Michigan

Assistant Professor of Neurology

One treatment was given.

Lidocaine in SphenoCath device: Participants received 2.5 cc of lidocaine 1% solution intranasally via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds.

Lidocaine in SphenoCath Device

One treatment was given.

Saline Solution in SphenoCath device: Participants received saline solution via a SphenoCath device into each nares. The portion of the procedure involving this device lasted approximately 30-60 seconds.

Saline Solution in SphenoCath Device

Total

20 to 45 years of age

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Michael Popovich

Because only one participant was involved in each arm, showing data could violate privacy interests.

Mean Change in Headache Severity Score

Patient Global Impression of Change (PGIC)

Mean Change in the Number of Headache Occurrences

Mean Headache Occurrences Within 48 Hours pre-and 48 Hours Post-SPG Block

Mean Headache Occurrences Within 1 Week Pre- and 1 Week Post-SPG Block

Mean Change in Headache Hours Per Day

Mean Headache Hours Per Day Within 48 Hours Pre- and 48 Hours Post-SPG Block

Mean Headache Hours Per Day Within 1 Week Pre and 1 Week Post Block

Mean Change in the Number of Days With Headache

Mean Number of Days With Headache in the1 Week Post-SPG Block Compared to 1 Week Pre-SPG Block.

Mean Change in As-needed Headache Treatment Uses

Mean As-needed Headache Treatment Uses Within 48 Hours Pre- and 48 Hours Post-SPG

Mean As-needed Headache Treatment Uses Within 1 Week Pre and 1 Week Post Block

Overall Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quality Improvement and Practice Based Research in Neurology Using the EMR	NCT02670161	Brain Tumors Epilepsy Migraine Mild Cognitive ... Concussion Multiple Sclero... Neuropathy Parkinson's Restless Legs S... Stroke	Listed for each...	18 Years - 100 Years	NorthShore University HealthSystem
Sphenopalatine Ganglion Block for Headache After Concussion	NCT04650282	Concussion Headache	Lidocaine in Sp... Saline Solution...	18 Years - 60 Years	University of Michigan
Quality Improvement and Practice Based Research in Neurology Using the EMR	NCT02670161	Brain Tumors Epilepsy Migraine Mild Cognitive ... Concussion Multiple Sclero... Neuropathy Parkinson's Restless Legs S... Stroke	Listed for each...	18 Years - 100 Years	NorthShore University HealthSystem

Spots Global Cancer Trial Database for concussion

Every month we try and update this database with for concussion cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for concussion

Every month we try and update this database with for concussion cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for concussion cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.