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Protocol Details

Investigation of Neurofeedback with Real-Time fMRI in Healthy Volunteers and Patients with Hyperkinetic Movement Disorders

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

09-N-0118

Sponsoring Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18
Max Age: 60

Referral Letter Required

No

Population Exclusion(s)

Children

Special Instructions

Currently Not Provided

Keywords

Neurofeedback;
Tourette Syndrome;
Healthy Volunteer;
Movement Disorder;
Brain Activity;
fMRI

Recruitment Keyword(s)

Movement Disorder;
HV;
Healthy Volunteer;
Tourette Syndrome

Condition(s)

Movement Disorder;
Tourette Syndrome;
Healthy Volunteer

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Neurological Disorders and Stroke

Background:

- Many people can learn to use feedback about brain activity to modify that activity, but is it not known if people with Tourette syndrome can modify their brain activity.

- Researchers have evidence that certain areas of the brain are involved in causing tics in people with Tourette syndrome. If people with Tourette syndrome can use feedback about brain activity to modify activity in those parts of the brain, they may be able to modify their brain activity to help control the tics.

Objectives:

- To determine if people with and without Tourette syndrome can learn to use thought to control brain activity.

- To test whether people who have Tourette syndrome can learn to control brain activities, possibly helping to control tics.

Eligibility:

- Healthy volunteers ages 18 and older who are right-handed and are willing to not consume caffeine or alcohol for 24 hours before the study visit.

- Patients with Tourette syndrome who have tics that can be observed and studied.

- All participants must be able to undergo magnetic resonance imaging (MRI) scans.

Design:

- Healthy volunteers (two visits to the NIH Clinical Center over a 2- to 4-week period; visit may last up to 3 hours):

-Screening visit, including physical examination and medical history, and a magnetic resonance imaging (MRI) scan if the individual has not had one performed at the National Institutes of Health in the past year.

-Study visit: Functional MRI (fMRI) scan to allow researchers to see if volunteers can learn to control their brain activity during a scan. Volunteers will be asked to complete tasks as directed during the fMRI scan.

- Patients with Tourette syndrome (three or four outpatient visits over a 4- to 6-week period; each visit may last up to 4 hours):

-Screening visit, including physical examination and medical history, and an MRI scan if the individual has not had one performed at the National Institutes of Health in the past year.

-Evaluation visit to ask questions about Tourette symptoms and to have patients complete questionnaires about their tics and their mental health.

-Study visit: fMRI scan to allow researchers to see if patients can learn to control their brain activity during a scan. Patients will be asked to complete tasks as directed during the fMRI scan.

-Final visit: Researchers will ask questions about tic symptoms, have patients complete questionnaires, and perform a brief exam. Afterward, patients will have an fMRI scan similar to the previous one.

- All participants will be paid a small amount of money in compensation for their participation in the study.

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Eligibility

INCLUSION CRITERIA:

Healthy Volunteers

1. Aged 18 to 60

2. Right-hand dominant

3. Have a normal neurological exam

4. Have the capacity to give informed consent

5. Willing to abstain from caffeine and alcohol for 24 hours prior to MRI scanning

TD Patients

1. Aged 18 to 60

2. Right-dominant

3. Have TS or chronic motor or vocal tic disorder diagnosis based on neurological examination and meeting criteria of the Diagnostic and Statistical Manual of Mental Disorders 4th 5th Edition (DSM-V)

4. Have the capacity to give informed consent

5. A Yale Global Tic Severity Scale (YGTSS) total score of at least 5

6. Willing to abstain from caffeine and alcohol for 24 hours prior to MRI scanning

7. If pharmacologically treated for TD, willing to not alter medication dosages or regimens between the screening visit and scanning visit for participants of Phase 2 or between the screening visit and follow-up visit for participants of Phase 3

EXCLUSION CRITERIA:

Healthy Volunteers

1. Pregnancy

2. Any abnormal findings on neurological exam

3. Any finding on the MRI safety questionnaire that prevents them from safely undergoing an MRI scan

4. Any medical condition that would prevent them from lying flat for up to 3 hours

5. Any history of central nervous system infection or inflammation, brain tumor, stroke, head trauma or a vascular malformation as obtained by history or from imaging studies

6. Presence of any active or medically treated neurological conditions such as epilepsy, multiple sclerosis, or a movement disorder

7. Presence of any active or medically treated psychiatric problems such as depression, OCD or ADHD

8. Presence of uncontrolled medical illnesses such as heart, lung, or kidney disease

9. Presence of claustrophobia or other restriction that prevents them from undergoing a scan in a confined space for up to 3 hours

10. Presence of continuous or excessive movements at rest or are unable to remain supine while undergoing a scan for up to 3 hours.

TD Patients

1. Pregnancy

2. Any finding on the MRI safety questionnaire that prevents them from safely undergoing an MRI scan

3. Any medical condition that would prevent them from lying flat for up to 3 hours

4. Any history of central nervous system infection or inflammation, brain tumor, stroke, head trauma or a vascular malformation as obtained by history or from imaging studies

5. Presence of uncontrolled psychiatric problems such as depression, OCD or ADHD

6. Patients with a history of a psychotic disorder such as schizophrenia

7. Patients with other movement disorders or progressive neurological disorders other than Tic disorders such as Multiple Sclerosis or epilepsy

8. Presence of uncontrolled medical illnesses such as heart, lung, or kidney disease

9. Presence of claustrophobia or other restrictions that prevent them from undergoing a scan in a confined space for up to 3 hours

10. Presence of continuous or excessive movements at rest or are unable remain supine while undergoing a scan for up to 3 hours

11. Presence of secondary form of tic disorder


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Citations:

Albin RL, Mink JW. Recent advances in Tourette syndrome research. Trends Neurosci. 2006 Mar;29(3):175-82. Epub 2006 Jan 23.

Banzett RB, Mulnier HE, Murphy K, Rosen SD, Wise RJ, Adams L. Breathlessness in humans activates insular cortex. Neuroreport. 2000 Jul 14; 11(10):2117-20.

Baym CL, Corbett BA, Wright SB, Bunge SA. Neural correlates of tic severity and cognitive control in children with Tourette syndrome. Brain. 2008 Jan;131(Pt 1):165-79

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Contacts:

Principal Investigator

Referral Contact

For more information:

Silvina G. Horovitz, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7D37
10 Center Drive
Bethesda, Maryland 20892
(301) 435-2163
silvina.horovitz@nih.gov

Elaine P. Considine, R.N.
National Institute of Neurological Disorders and Stroke (NINDS)
National Institutes of Health
Building 10
Room 7D36
10 Center Drive
Bethesda, Maryland 20892
(301) 435-8518
considinee@ninds.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT00885040

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