Protocol Number: 09-N-0118

Title:

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

Number:

09-N-0118

Summary:

Objective:

The objective of this study is to see if healthy volunteers and patients with hyperkinetic movement disorders such as Tourette Syndrome (TS) are able to learn how to alter their brain activity using feedback during functional magnetic resonance imaging (fMRI), and whether such feedback training can lead to improvement in symptoms in TS patients.

Study population:

This study is to be carried out in three phases. In Phase 1 we will study the feedback technique using fMRI with right-handed adult healthy volunteers, in Phase 2 we intend to study if right-handed adult patients with TS are also able to learn the feedback technique, and in Phase 3 we intend to study whether feedback training with fMRI leads to improvement in symptoms in TS patients and whether patients were able to retain the ability to alter their brain activity.

Design:

Phase 1: Healthy volunteers will be shown an image that corresponds to their brain activity being measured continuously during fMRI scanning and asked to attempt to alter this activity first with a simple finger-tapping task and then with their thoughts. Phase 1 will require two visits (one screening and one scanning).

Phase 2: TS patients will be studied to see if they can learn to alter their brain activity in a similar way as the healthy volunteers. Patients will have their symptoms videotaped and a brief neurological exam just before and after scanning. Phase 2 will require three visits (one screening, one evaluation, and one scanning).

Phase 3: The effect of altering brain activity in a specific brain area on symptoms in TS patients will be studied. Patients will be asked to continue to focus their thoughts as they did during feedback scanning any time that they feel an urge prior to a tic or every hour while awake, whichever is more frequent, until a follow-up visit and fMRI scan two or three days later. Phase 3 will require four visits (one screening, one evaluation, one scanning, and one follow-up). No visit will last more than 4 hours.

Outcome measures:

The primary outcome for Phases 1 and 2 is the difference in brain activation within a specific area after feedback training compared to a baseline, and for Phase 3 it is the difference in symptoms measured by a TS rating scale before fMRI scanning compared to two or three days after learning the feedback technique. Secondary outcomes for all three phases include the changes in activation in a specific brain area compared to a baseline after repeated scanning trials and when no feedback image is displayed.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

Healthy Volunteer

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

TS Patients

1. Aged 18 to 60

2. Right-dominant

3. Have TS diagnosis based on neurological examination and meeting criteria of the Diagnostic and Statistical Manual of Mental Disorders 4th Edition (DSM-IV)

4. Have the capacity to give informed consent

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

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

7. If pharmacologically treated for TS, 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 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.

TS 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 Tourette syndrome 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

Special Instructions:

Currently Not Provided

Keywords:

Neurofeedback

Tourette Syndrome

Healthy Volunteer

Movement Disorder

Brain Activity

Recruitment Keyword(s):

None

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

Contact(s):

Elaine P. Considine, R.N.
National Institutes of Health
Building 10
Room 7D26A
10 Center Drive
Bethesda, Maryland 20892
Phone: (301) 435-8518
Fax: (301) 480-2286
Electronic Address: considinee@ninds.nih.gov

Citation(s):

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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