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Neurofeedback for Tourette Syndrome

Primary Purpose

Tourette Syndrome, Chronic Tic Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neurofeedback
Sham feedback
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome focused on measuring neurofeedback, biofeedback, real-time fMRI, rt-fMRI, functional connectivity, fMRI

Eligibility Criteria

11 Years - 19 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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, with the exception that predisposition to migraine will not be grounds for exclusion
  • 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.

Sites / Locations

  • Yale University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Neurofeedback first

Sham first

Arm Description

Neurofeedback then sham feedback

Sham feedback then neurofeedback

Outcomes

Primary Outcome Measures

Tic severity
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
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
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
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.

Full Information

First Posted
October 3, 2012
Last Updated
August 24, 2018
Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01702077
Brief Title
Neurofeedback for Tourette Syndrome
Official Title
Neurofeedback of Activity in the Supplementary Motor Area for Tourette Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
October 2012 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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 (fMRI) 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome, Chronic Tic Disorder
Keywords
neurofeedback, biofeedback, real-time fMRI, rt-fMRI, functional connectivity, fMRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Neurofeedback first
Arm Type
Experimental
Arm Description
Neurofeedback then sham feedback
Arm Title
Sham first
Arm Type
Experimental
Arm Description
Sham feedback then neurofeedback
Intervention Type
Procedure
Intervention Name(s)
Neurofeedback
Other Intervention Name(s)
biofeedback, real-time fMRI biofeedback
Intervention Type
Procedure
Intervention Name(s)
Sham feedback
Primary Outcome Measure Information:
Title
Tic severity
Description
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.
Time Frame
Tic severity assessed approximately half a week PRIOR TO beginning biofeedback/sham feedback.
Title
Tic severity
Description
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.
Time Frame
Tic severity assessed approximately half a week AFTER completing biofeedback/sham feedback.
Secondary Outcome Measure Information:
Title
Control over target brain area
Description
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.
Time Frame
Assessed approximately half a week BEFORE biofeedback/sham biofeedback.
Title
Control over target brain area
Description
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.
Time Frame
Assessed approximately half a week AFTER biofeedback/sham biofeedback.
Other Pre-specified Outcome Measures:
Title
Functional connectivity patterns in the brain
Description
Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
Time Frame
Assessed approximately half a week BEFORE biofeedback/sham biofeedback.
Title
Functional connectivity patterns in the brain
Description
Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.
Time Frame
Assessed approximately half a week AFTER biofeedback/sham biofeedback.
Title
Clinical improvement
Description
The Clinical Global Impression - Improvement scale will be used to assess improvement over the course of the biofeedback/sham feedback
Time Frame
Clinical improvement will be assessed approximately half a week AFTER biofeedback/sham feedback

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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, with the exception that predisposition to migraine will not be grounds for exclusion 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Hampson, Ph.D.
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States

12. IPD Sharing Statement

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Neurofeedback for Tourette Syndrome

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