Neoplasms

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Head and Neck Neoplasms

Nasopharyngeal Carcinoma

Xerostomia

Salivary Gland Diseases

Mouth Diseases

Stomatognathic Diseases

Participants recruited between weeks 3-5 of radiotherapy. Acupuncture treatments given within 3 to 7 days of each other during Weeks 3-5 of regularly scheduled radiotherapy visits. It should take about 20 minutes to complete the acupuncture session each time.

At each acupuncture session, 3 questionnaires completed before each session that ask about dry mouth, any other symptoms, and treatment expectations. It should take about 5 minutes total to complete these questionnaires. Participants also complete another brief questionnaire about dry mouth after each session. It should take about 1 minute to complete this questionnaire.

Participants also have an EEG at each acupuncture treatment. EEG recorded 5 minutes before acupuncture, during acupuncture, and for 5 minutes after acupuncture. Total visit time will last about 45-60 minutes.

At each acupuncture session, 3 questionnaires completed before each session that ask about dry mouth, any other symptoms, and treatment expectations. It should take about 5 minutes total to complete these questionnaires. Participants also complete another brief questionnaire about dry mouth after each session. It should take about 1 minute to complete this questionnaire.

Questionnaires

Acupuncture treatments given within 3 to 7 days of each other during Weeks 3-5 of regularly scheduled radiotherapy visits. It should take about 20 minutes to complete the acupuncture session each time.

Acupuncture

Participants have an EEG at each acupuncture treatment. EEG recorded 5 minutes before acupuncture, during acupuncture, and for 5 minutes after acupuncture. Total visit time will last about 45-60 minutes.

Electroencephalogram (EEG)

Lorenzo Cohen, PHD

The goal of this clinical research study is to learn which areas of the brain respond to acupuncture that is designed to prevent xerostomia (dry mouth) in patients with head and neck cancer. Researchers also want to learn if acupuncture can help prevent dry mouth and improve patient quality of life.

Dry mouth is a common problem in cancer patients who have received radiation treatment to the head and neck. Acupuncture is a technique that may treat symptoms by inserting very thin, solid, sterile, stainless steel needles into the skin at specific points.

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned (as in the flip of a coin) into 1 of 2 groups. You will have an equal chance of being in either group.

Group 1 will receive one type of acupuncture for one session and another type of acupuncture for the second session.

Group 2 will receive one type of acupuncture for one session and another type of acupuncture for the second session.

You will not know if you are assigned to Group 1 or Group 2.

Study Visits:

Your acupuncture treatments will be within 3 to 7 days of each other during Weeks 3-5 of your regularly scheduled radiotherapy visits. It should take about 20 minutes to complete the acupuncture session each time.

At each acupuncture session, you will complete 3 questionnaires before each session that ask about dry mouth, any other symptoms you may be having, and your treatment expectations. It should take about 5 minutes total to complete these questionnaires. You will also complete another brief questionnaire about dry mouth after each session. It should take about 1 minute to complete this questionnaire.

You will also have an EEG at each acupuncture treatment. The EEG will be recorded 5 minutes before acupuncture, during acupuncture, and for 5 minutes after acupuncture. Total visit time will last about 45-60 minutes.

You will give a saliva sample before and after each acupuncture treatment to measure the amount of saliva produced.

Length of Study:

You will remain on study for about 1 week. Your participation in the study will be over after you complete the dry mouth questionnaire after your second acupuncture session.

This is an investigational study.

Up to 50 patients will take part in this multicenter study. Up to 30 will be enrolled at MD Anderson.

Neurological Effects of Acupuncture to Prevent Radiation-induced Xerostomia

Primary outcome variables include percentage changes of EEG scores at the medial frontal gyrus, precuneus, and anterior cingulate regions from pre- to post-acupuncture at each acupuncture session. Repeated measures ANOVA used for the analysis, with fixed effects of sequence (order of acupuncture sessions), treatment (each acupuncture group), and period (1st vs 2nd session), and random patient (nested within sequence) effects included. Adjustments for multiple testing made according to the method of Westfall and Young.

Secondary outcomes are to determine between-acupuncture differences in radiation-induced xerostomia. Association examined between changes in neural outcomes and changes in salivary flow and self-report measures of xerostomia and other quality of life measures, controlling for the factors of acupuncture and period (1st vs 2nd) as appropriate.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Anti-Inflammatory Agents

All Drugs and Chemicals

Hydrocortisone

Hydrocortisone 17-butyrate 21-propionate

Hydrocortisone acetate

Hydrocortisone hemisuccinate

Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver.

Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.

Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.

Questionnaires completed at baseline visit, 1 month after baseline. EEG performed with simultaneous computer testing. Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.

Questionnaires and testing repeated 7 days after the residential program ends, and then again about 3 months later.

Participants attend a 7-day offsite, residential support program. On Day 5 of the program, participant joined by spouse or caregiver.

Residential Program

Questionnaires completed about mood, sleep, fatigue, how participant has been feeling, and their general quality of life at baseline visit, 1 month after baseline, 7 days after residential program ends, and again about 3 months later.

EEG performed at baseline with simultaneous computer testing consisting of 3 tests to check attention, short-term memory, and levels of emotions. EEG repeated 7 days after the residential program ends, and then again about 3 months later.

Day after baseline visit, saliva collected for 3 days at different times to measure cortisol levels. Saliva testing repeated 7 days after the residential program ends, and then again about 3 months later.

Saliva Testing

For seven days after baseline visit, participants complete study diary describing sleeping habits. An actigraph also worn during this time to record physical activity and sleeping habits.

Study Diary plus Actigraph

The goal of this behavioral research study is to compare 2 different types of residential group programs to help researchers learn if and how well these groups may help to improve physical and emotional well-being in patients with stage IV breast cancer.

Baseline Visit:

Signing this consent form does not mean that you will be able to take part in this study. The following baseline tests will help the doctor decide if you are eligible:

* You will complete 7 questionnaires about your mood, sleep, fatigue, how you have been feeling, and your general quality of life. The questionnaires should take about 60-80 minutes to complete.
* You will have an electroencephalogram (EEG) to check your brain's electrical activity. During the EEG, a snug cap with small electrodes will be placed on your head to measure the electrical patterns coming from the brain. This is like the way a doctor listens to your heart from the surface of your skin. During the EEG, you will complete 3 tests to check your attention, short-term memory, and levels of emotions on the computer. The study staff will discuss each test in more detail with you. The EEG and tests will take about 45-60 minutes total.
* If you have not had a computed tomography (CT) scan in the last 2 months, you will have one performed to check the status of the disease. If you have had one in the last 2 months, the results will be collected from your medical records.
* You will have an electrocardiogram (EKG) to check your heart function.
* Blood (about 6 tablespoons) will be drawn for tests to measure hormones and your immune system responses. You will need to fast (not eat or drink anything except water) for 12 hours before this blood draw. You will be provided with healthy snacks after your blood draw.

The day after your baseline visit, saliva will be collected to measure the level of cortisol (a type of stress hormone) in your body. These saliva samples will be collected 4 times each day for 3 days in a row. You will collect these samples at home when you first wake up, about 45 minutes later, about 10 hours after waking up, and then at bedtime. To collect each saliva sample, you will chew on a cotton ball for a few seconds and then put the cotton in a small plastic tube. You will write down the times you took these samples. You will mail these samples back to MD Anderson in postage-paid envelopes that will be provided to you. The tubes will also be provided at no cost to you. These saliva samples will be destroyed after being studied.

Every day for the next 7 days after your baseline visit, you will fill out a diary about your sleeping habits. You will also wear a special type of wrist watch for these 7 days. The watch will collect data about your physical activity and sleeping habits. After you have worn it for 7 days, you will mail the watch and the sleep diary back to MD Anderson in postage-paid envelopes that will be provided to you.

Extended Baseline:

You will be asked to complete and provide all the same measures again 1 month after the first baseline visit.

Study Groups:

If you are found to be eligible to take part in this study and you agree, you will be randomly assigned (as in the roll of dice) to 1 of 3 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group.

* If you are assigned to Groups 1 or 2, you will take part in 1 of 2 types of residential group programs.
* If you are assigned to Group 3, you will receive standard cancer care without any participation in a residential group program.

If you are assigned to Groups 1 or 2, neither you nor the study staff will know what kind of residential group program you are in.

Residential Support Program Sessions (Groups 1 and 2 only):

You will take part in a 7-day offsite, residential support program in groups of about 10 participants each. On Day 5 of the retreat, you will be joined by your spouse or caregiver.

During the 7 days, you will take part in group activities, learn relaxation skills, do different cognitive activities (for example, reading, watching movies, and having group discussions), and learn about mind-body connections. You will spend 7 days and 6 nights at the residential retreat. Activities at the retreat will last about 12 hours per day with breaks, group meals, and free time to rest in the morning, afternoon and evening, or as needed.

At least 1 week before the retreat, you will be given a detailed agenda and schedule of all activities that will occur during the retreat.

Follow-Up Sessions (All Groups):

You will complete the same tests/procedures that were performed at the baseline visit within 7 days after the residential program ends and then again about 3 months later. If you are in Group 3, you will complete the same tests/procedures on the same schedule.

Length of Participation:

Your participation on this study will be over after you complete the follow-up sessions.

Depending on which study group you were assigned to, you may be able to take part in a residential program that you did NOT previously take part in. The study chair or research staff will discuss this option with you.

This is an investigational study.

Up to 100 participants and their caregivers will take part in this multicenter study. Up to 74 will be enrolled at MD Anderson.

Effects of a Group Residential Retreat on Cancer Outcomes

Participant compliance with assessments monitored as well as participation in all aspects of the intervention program. Intervention deemed feasible if ≥ 60% of enrolled couples complete all assessments and attend the assigned retreat.

Nervous System Diseases

Heart and Blood Diseases

Stroke

Epilepsy

Brain Diseases

Central Nervous System Diseases

High-density EEG will be used for brain localization in epilepsy patients

High-density EEG will be used for brain localization in healthy controls

High-density EEG will be used for brain localization in tumor patients

High-density EEG will be used for brain localization in patients with peripheral nerve dysfunction

High-density EEG will be used for brain localization in patients who have recently experienced a stroke

This study will focus on obtaining a special type of high-density scalp electroencephalography (HD-EEG) recordings in patients with neurological disorders (i.e., epilepsy, brain tumor, stroke, etc.) and appropriately matched controls. HD-EEG is a scalp EEG which uses up to 256 channels compared to the standard 21 channels used for routine clinical applications. The reason for using more channels to record is for more precise localization of epileptogenic foci and/or more precise mapping of brain functions. This type of EEG requires the use of patient's own MRI scan to precisely localize activity. Therefore, all patients and controls getting an HD-EEG will require a structural MRI scan.

High-density electroencephalogram (HD-EEG)

The purpose of the study is to use a new method of high-density electroencephalogram (HD-EEG) recording to map brain areas important for movement, sensation, language, emotion, and cognition.

This study will measure brain waves using high-density EEG. Participants will be asked wear a cap with electrodes attached to it. During the recording, participants may be asked to rest, sleep, or complete a task. The tasks involve viewing pictures, answering questions, speaking, or moving an arm or leg. Recordings generally last between 60-120 minutes.\*

High-density EEG in Neurological Disorders

Localize brain functions using high-density EEG recordings

Localize brain areas involved in language using high-density EEG recordings

Localize brain areas involved in movement using high-density EEG recordings

Localize brain areas involved in sensation using high-density EEG recordings

Localize brain areas involved in emotion using high-density EEG recordings

Localize brain areas involved in memory using high-density EEG recordings

Localize brain areas associated with lesions using high-density EEG recordings

Dartmouth-Hitchcock Medical Center

Clinical Neurophysiologist, Neuro Diagnostics

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Central Nervous System Depressants

Propofol

Hypnotics and Sedatives

Anesthetics

Anesthetics, Intravenous

Anesthetics, General

1% propofol is used for target-controlled infusion, and gradually increase the effect concentration at 0.2ug/ml. Make the subject's sedation depth reach light sedation and deep sedation respectively. EEG data were collected during wakefulness, light sedation, deep sedation, and recovery.

Propofol Injection

Ruquan Han, M.D., Ph.D

The growth of gliomas often infiltrates important brain tissues and impairs subcortical fiber transmission, resulting in changes in global brain network connectivity. Most of the current anesthesia depth monitoring methods are based on healthy brain function population，which is difficult to reflect the sedation depth of glioma patients accurately. Therefore, this study aims to explore the characteristics of brain network connectivity in glioma patients under different sedation depths by electroencephalogram (EEG) and auditory event-related potential (AERP) methods, which may provide a research basis for sedative titration and anesthesia depth identification in glioma patients.

Effects of Propofol on Auditory Event-related Potentials and Brain Functional Connectivity in Patients With Supratentorial Glioma

Using coherence ; phase slope index(PSI); phase locking value(PLV）;phase lag index(PLI）to evaluate the brain network functional connectivity of subjects

Beijing Tiantan Hospital

Head of anesthesiology, Principal Investigator, Clinical Professor

Symptoms and General Pathology

Behaviors and Mental Disorders

Diseases and Abnormalities at or Before Birth

Sclerosis

Parasomnias

Tuberous Sclerosis

Sleep Wake Disorders

Neurologic Manifestations

Mental Disorders

Psychotic Disorders

Hamartoma

Neoplasms, Multiple Primary

Syndrome

Neoplastic Syndromes, Hereditary

Congenital Abnormalities

Malformations of Cortical Development

Nervous System Malformations

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Tuberous Sclerosis Complex

Questionnaires electroencephalogram (EEG) Actigraphy polysomnography

* Epworth sleepiness scale
* Pittsburgh sleep quality Index (PSQI)
* EQ-5D Adults
* Pediatric Daytime Sleepiness scale (PDSS)
* Sleep disturbance Scale for Children (SDSC
* EQ-5D Children
* Sleaping diary

is an electrophysiological monitoring method to record electrical activity of the brain

electroencephalogram (EEG)

type of sleep study, is a multi-parametric test used in the study of sleep and as a diagnostic tool in sleep medicine

polysomnography

type of sleep study based on bracelet around the wrist

Actigraphy

Veerle Van Mossevelde, Study coordinator

Dirk De Clippeleir, Study coordinator

Veerle Van Mossevelde, Datanurse

Anna Jansen, PhD, MD

Sonia De Weerdt, MD

Alessandra Pereira,, PhD, MD

Magda Nunes, PhD, MD

Oliviero Bruni, PhD, MD

Paolo Curatolo, PhD, MD

The proposed research project is aimed at further characterization of sleep problems and evaluation of their impact in children and adults with TSC, excluding epilepsy as contributing factor. Questionnaire-based studies have shown that sleep problems occur in up to half of the children and a third of adults with tuberous sclerosis complex (TSC). However, there is only limited information on the nature of sleep problems and their impact on patients with TSC and their families.

Questionnaire-based studies have shown that sleep problems occur in up to half of the children and a third of adults with tuberous sclerosis complex (TSC). However, there is only limited information on the nature of sleep problems and their impact on patients with TSC and their families. It is known from a questionnaire-based study in children with TSC that they often wake early or wake frequently during the night, and that they can be more tired during the day. In some children, sleep-problems seem to be related to the presence of seizures during the night. This has been confirmed in a study on 10 children with TSC and epilepsy by a combination of polysomnography (sleep study) and electroencephalography (EEG). A questionnaire-based study in adults also revealed the association with epilepsy features, and showed influence of mental health complaints on sleep.

Sleep structure and quality will be assessed through formal sleep studies (polysomnography and actigraphy). The influence of abnormal brain activity on sleep will be mapped by simultaneous recording of brain activity by means of EEG. The impact of sleep disorders will be determined through interviews with individuals with TSC and their relatives. The investigators will also use questionnaires and diaries to supplement their findings.

Importance: It is expected that the results of this study will 1) improve our understanding of sleep problems in TSC, 2) provide additional information on the influence of TSC on sleep, 3) give a more in-depth view on the impact of sleep problems on the lives of individuals with TSC and their families, 4) increase awareness about sleep problems in TSC, and 5) contribute to a better management of sleep problems by patients and families.

2 groups:

* 30 Children(0-18y) withTSC without epilepsy
* 30 Adults(\>18y) withTSC without epilepsy

Characterizing Sleep Disorders in Children and Adults With Tuberous Sclerosis Complex (TSC)

- Sleep efficiency (SE%): the percentage ratio between total sleep time and time in bed (TST/TIB\*100)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Neurological Effects of Acupuncture to Prevent Radiation-induced Xerostomia	NCT02292368	Head and Neck C...	Questionnaires Acupuncture Electroencephal...	18 Years -	M.D. Anderson Cancer Center
Effects of a Group Residential Retreat on Cancer Outcomes	NCT02429544	Breast Cancer	Residential Pro... Questionnaires Electroencephal... Saliva Testing Study Diary plu...	50 Years -	M.D. Anderson Cancer Center
High-density EEG in Neurological Disorders	NCT04266041	Epilepsy Tumor Healthy	High-density el...	18 Years -	Dartmouth-Hitchcock Medical Center
Effects of Propofol on Auditory Event-related Potentials and Brain Functional Connectivity in Patients With Supratentorial Glioma	NCT05352685	Propofol Glioma Auditory Event-... Electroencephal... Brain Network C...	Propofol Inject...	18 Years - 60 Years	Beijing Tiantan Hospital
Characterizing Sleep Disorders in Children and Adults With Tuberous Sclerosis Complex (TSC)	NCT03326765	Sleep Disorder	Questionnaires electroencephal... polysomnography Actigraphy	1 Day - 70 Years	Universitair Ziekenhuis Brussel
Effects of a Group Residential Retreat on Cancer Outcomes	NCT02429544	Breast Cancer	Residential Pro... Questionnaires Electroencephal... Saliva Testing Study Diary plu...	50 Years -	M.D. Anderson Cancer Center
Neurological Effects of Acupuncture to Prevent Radiation-induced Xerostomia	NCT02292368	Head and Neck C...	Questionnaires Acupuncture Electroencephal...	18 Years -	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for electroencephalogram (eeg)