Investigation of Neurofeedback With Real-Time fMRI in Healthy Volunteers and Patients With Hyperkinetic Movement Disorders
- 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.
|Study Design:||Time Perspective: Prospective|
|Official Title:||Investigation of Neurofeedback With Real-Time fMRI in Healthy Volunteers and Patients With Hyperkinetic Movement Disorders|
- 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...
|Study Start Date:||April 7, 2009|
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 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 TD patients.
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 TD 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 TD patients and whether patients were able to retain the ability to alter their brain activity.
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 1b: 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 with their thoughts while they are suppressing blinks.
Phase 2: TD 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 TD 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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885040
|Contact: Elaine P Considine, R.N.||(301) email@example.com|
|Contact: Mark Hallett, M.D.||(301) firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator:||Mark Hallett, M.D.||National Institute of Neurological Disorders and Stroke (NINDS)|