Trial record 16 of 79 for:
"Tourette Syndrome"
Neurofeedback for Tourette Syndrome
This study is currently recruiting participants.
Verified January 2013 by Yale University
Sponsor:
Yale University
Collaborator:
Information provided by (Responsible Party):
Yale University
ClinicalTrials.gov Identifier:
NCT01702077
First received: October 3, 2012
Last updated: January 18, 2013
Last verified: January 2013
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Purpose
The aim of this study is to train patients with tic disorders to control activity in a region of their brain that has been associated with the urge to tic. Patients will be given direct feedback regarding activity in this brain area while they are undergoing functional magnetic resonance imaging scanning, and will try to learn to control activity in the region during these feedback sessions. In separate sessions, patients will be given sham feedback based on the brain patterns of a prior subject rather than their own brain patterns. Our primary hypothesis is that the biofeedback training will reduce their tic symptoms more than the sham feedback.
| Condition | Intervention |
|---|---|
|
Tourette Syndrome Chronic Tic Disorder |
Procedure: Neurofeedback Procedure: Sham feedback |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Neurofeedback of Activity in the Supplementary Motor Area for Tourette Syndrome |
Resource links provided by NLM:
Genetics Home Reference related topics:
Tourette syndrome
MedlinePlus related topics:
Tourette Syndrome
U.S. FDA Resources
Further study details as provided by Yale University:
Primary Outcome Measures:
- Tic severity [ Time Frame: Tic severity assessed approximately half a week PRIOR TO beginning biofeedback/sham feedback. ] [ Designated as safety issue: No ]A modified version of the Yale Global Tic Severity Scale (YGTSS) will be used, that queries subjects regarding symptoms over the last 3 days (rather than the 2 week period used in the standard scale). Total YGTSS score on this modified scale will be used as the measure of tic severity.
- Tic severity [ Time Frame: Tic severity assessed approximately half a week AFTER completing biofeedback/sham feedback. ] [ Designated as safety issue: No ]A modified version of the Yale Global Tic Severity Scale (YGTSS) will be used, that queries subjects regarding symptoms over the last 3 days (rather than the 2 week period used in the standard scale). Total YGTSS score on this modified scale will be used as the measure of tic severity.
Secondary Outcome Measures:
- Control over target brain area [ Time Frame: Assessed approximately half a week BEFORE biofeedback/sham biofeedback. ] [ Designated as safety issue: No ]Control task scans will be conducted in which subjects are cued to alternately increase and decrease activity in their target area without receiving any feedback. The percent signal change in the BOLD signal in the target area during increase relative to decrease blocks will be used as the measure of control over the brain area.
- Control over target brain area [ Time Frame: Assessed approximately half a week AFTER biofeedback/sham biofeedback. ] [ Designated as safety issue: No ]Control task scans will be conducted in which subjects are cued to alternately increase and decrease activity in their target area without receiving any feedback. The percent signal change in the BOLD signal in the target area during increase relative to decrease blocks will be used as the measure of control over the brain area.
Other Outcome Measures:
- Functional connectivity patterns in the brain [ Time Frame: Assessed approximately half a week BEFORE biofeedback/sham biofeedback. ] [ Designated as safety issue: No ]Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
- Functional connectivity patterns in the brain [ Time Frame: Assessed approximately half a week AFTER biofeedback/sham biofeedback. ] [ Designated as safety issue: No ]Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
- Clinical improvement [ Time Frame: Clinical improvement will be assessed approximately half a week AFTER biofeedback/sham feedback ] [ Designated as safety issue: No ]The Clinical Global Impression - Improvement scale will be used to assess improvement over the course of the biofeedback/sham feedback
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | June 2017 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Neurofeedback first
Neurofeedback then sham feedback
|
Procedure: Neurofeedback
Other Names:
Procedure: Sham feedback
|
|
Experimental: Sham first
Sham feedback then neurofeedback
|
Procedure: Neurofeedback
Other Names:
Procedure: Sham feedback
|
Eligibility| Ages Eligible for Study: | 11 Years to 19 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of Tourette Syndrome or Chronic Tic Disorder
- currently active tics
- aged 11-19
- ability to execute most common tics without moving head while lying on back
Exclusion Criteria:
- Blindness (because feedback is provided visually)
- Lifetime diagnosis of pervasive developmental disorder, bipolar disorder, or psychotic disorder.
- Presence of any serious psychiatric or psychosocial condition requiring initiation of new treatment or change in current treatment.
- Neurological conditions affecting central nervous system
- Change in medication in the month prior to beginning the study
- Unwillingness to keep medication stable over the course of the intervention
- Full braces (but some retainers are OK)
- Claustrophobia of a degree that they cannot comfortably be scanned
- If common tics involve dramatic changes in breathing that could alter blood oxygenation measurements
- Inability to keep head still while executing most common tics
- Inability to keep head still in mock scanner
- Inability or unwillingness to understand or follow the instructions
- Pregnancy or possible pregnancy
- Subjects may also be excluded after the first magnetic resonance scan if we are unable to localize a region of their supplementary motor area involved in tics - leaving us without a target area for biofeedback.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702077
Contacts
| Contact: Christopher Walsh, MS | 203-737-6055 | christopher.walsh@yale.edu |
Locations
| United States, Connecticut | |
| Yale University School of Medicine | Recruiting |
| New Haven, Connecticut, United States, 06520 | |
Sponsors and Collaborators
Yale University
Investigators
| Principal Investigator: | Michelle Hampson, Ph.D. | Yale University |
More Information
No publications provided
| Responsible Party: | Yale University |
| ClinicalTrials.gov Identifier: | NCT01702077 History of Changes |
| Other Study ID Numbers: | 0206017435, R01MH095789 |
| Study First Received: | October 3, 2012 |
| Last Updated: | January 18, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Yale University:
|
neurofeedback biofeedback real-time fMRI |
rt-fMRI functional connectivity fMRI |
Additional relevant MeSH terms:
|
Tourette Syndrome Tic Disorders Tics Movement Disorders Central Nervous System Diseases Nervous System Diseases Mental Disorders Diagnosed in Childhood Mental Disorders |
Dyskinesias Neurologic Manifestations Signs and Symptoms Basal Ganglia Diseases Brain Diseases Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases Genetic Diseases, Inborn |
ClinicalTrials.gov processed this record on May 23, 2013