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 : April 20, 2018
- 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.
- 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.
- 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.
- 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|
|Official Title:||Investigation of Neurofeedback With Real-Time fMRI in Healthy Volunteers and Patients With Hyperkinetic Movement Disorders|
|Study Start Date :||April 17, 2009|
- 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.
- 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...
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885040
|Contact: Elaine P Considine, R.N.||(301) firstname.lastname@example.org|
|Contact: Silvina G Horovitz, Ph.D.||(301) email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Silvina G Horovitz, Ph.D.||National Institute of Neurological Disorders and Stroke (NINDS)|