Trial record 1 of 9 for:    tourette's fMRI
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Investigation of Neurofeedback With Real-Time fMRI in Healthy Volunteers and Patients With Hyperkinetic Movement Disorders

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00885040
First received: April 18, 2009
Last updated: March 14, 2014
Last verified: January 2014
  Purpose

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.

Condition
Movement Disorder
Tourette Syndrome
Healthy Volunteer

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Investigation of Neurofeedback With Real-Time fMRI in Healthy Volunteers and Patients With Hyperkinetic Movement Disorders

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Phase 1 & amp; 2: Difference in BOLD signal in a ROI during neurofeedback after training compared to resting baseline. Phase 3: Change in YGTSS measured prior to neurofeedback training compared to the score measured at a follow-up visit.

Secondary Outcome Measures:
  • Difference in BOLD signal in a ROI during neurofeedback compared to a resting baseline after subsequent scanning runs and during a transfer task, and in Phase 3 compared to controls. Also any changes of neurofeedback on various disease measures...

Estimated Enrollment: 95
Study Start Date: April 2009
Detailed Description:

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) (completed).

Phase 1a: A pilot study evaluating the ability of healthy volunteers to learn to modulate their own brain connectivity using feedback of connectivity patterns between two motor regions during a real-time fMRI paradigm. Phase 1a will require three visits (one screening and two scanning with evaluation).

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 interview 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • 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

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 at 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 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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00885040

Contacts
Contact: Elaine P Considine, R.N. (301) 435-8518 considinee@ninds.nih.gov
Contact: Mark Hallett, M.D. (301) 496-9526 hallettm@ninds.nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Mark Hallett, M.D. National Institute of Neurological Disorders and Stroke (NINDS)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00885040     History of Changes
Other Study ID Numbers: 090118, 09-N-0118
Study First Received: April 18, 2009
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Neurofeedback
Tourette Syndrome
Healthy Volunteer
Movement Disorder
Brain Activity
fMRI
HV

Additional relevant MeSH terms:
Tourette Syndrome
Movement Disorders
Hyperkinesis
Central Nervous System Diseases
Nervous System Diseases
Basal Ganglia Diseases
Brain Diseases
Tic Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Mental Disorders Diagnosed in Childhood
Mental Disorders
Dyskinesias
Neurologic Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014