Status:
TERMINATED
Investigation of Neurofeedback With Real-Time fMRI in Healthy Volunteers and Patients With Hyperkinetic Movement Disorders
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Movement Disorder
Tourette Syndrome
Eligibility:
All Genders
18-60 years
Brief Summary
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 h...
Detailed Description
Objective: The objective of this study is to see if healthy volunteers and patients with hyperkinetic movement disorders such as Tic Disorders (TD) including Tourette Syndrome (TS) are able to learn ...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Healthy Volunteers
- Aged 18 to 60
- Right-hand dominant
- Have a normal neurological exam
- Have the capacity to give informed consent
- Willing to abstain from caffeine and alcohol for 24 hours prior to MRI scanning
- TD Patients
- Aged 18 to 60
- Right-dominant
- 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)
- Have the capacity to give informed consent
- A Yale Global Tic Severity Scale (YGTSS) total score of at least 5
- Willing to abstain from caffeine and alcohol for 24 hours prior to MRI scanning
- 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
- Pregnancy
- Any abnormal findings on neurological exam
- Any finding on the MRI safety questionnaire that prevents them from safely undergoing an MRI scan
- Any medical condition that would prevent them from lying flat for up to 3 hours
- 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
- Presence of any active or medically treated neurological conditions such as epilepsy, multiple sclerosis, or a movement disorder
- Presence of any active or medically treated psychiatric problems such as depression, OCD or ADHD
- Presence of uncontrolled medical illnesses such as heart, lung, or kidney disease
- Presence of claustrophobia or other restriction that prevents them from undergoing a scan in a confined space for up to 3 hours
- 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
- Pregnancy
- Any finding on the MRI safety questionnaire that prevents them from safely undergoing an MRI scan
- Any medical condition that would prevent them from lying flat for up to 3 hours
- 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
- Presence of uncontrolled psychiatric problems such as depression, OCD or ADHD
- Patients with a history of a psychotic disorder such as schizophrenia
- Patients with other movement disorders or progressive neurological disorders other than Tic disorders such as Multiple Sclerosis or epilepsy
- Presence of uncontrolled medical illnesses such as heart, lung, or kidney disease
- Presence of claustrophobia or other restrictions that prevent them from undergoing a scan in a confined space for up to 3 hours
- Presence of continuous or excessive movements at rest or are unable remain supine while undergoing a scan for up to 3 hours
- Presence of secondary form of tic disorder
Exclusion
Key Trial Info
Start Date :
April 17 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 20 2019
Estimated Enrollment :
59 Patients enrolled
Trial Details
Trial ID
NCT00885040
Start Date
April 17 2009
End Date
June 20 2019
Last Update
June 24 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892