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Trial record 4 of 650 for:    Recruiting, Not yet recruiting, Available Studies | "Movement Disorders"

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

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ClinicalTrials.gov Identifier: NCT00885040
Recruitment Status : Recruiting
First Posted : April 21, 2009
Last Update Posted : May 21, 2018
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Neurological Disorders and Stroke (NINDS) )

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 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 or disease
Movement Disorder Tourette Syndrome Healthy Volunteer

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 110 participants
Time Perspective: Prospective
Official Title: Investigation of Neurofeedback With Real-Time fMRI in Healthy Volunteers and Patients With Hyperkinetic Movement Disorders
Study Start Date : April 17, 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Phase 1 & 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 :
  1. 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...


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885040


Contacts
Contact: Elaine P Considine, R.N. (301) 435-8518 considinee@ninds.nih.gov
Contact: Silvina G Horovitz, Ph.D. (301) 435-2163 silvina.horovitz@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 Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
Principal Investigator: Silvina G Horovitz, Ph.D. National Institute of Neurological Disorders and Stroke (NINDS)

Additional Information:
Publications:
Responsible Party: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00885040     History of Changes
Other Study ID Numbers: 090118
09-N-0118
First Posted: April 21, 2009    Key Record Dates
Last Update Posted: May 21, 2018
Last Verified: February 13, 2018

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

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