Neurofeedback for Tourette Syndrome

NCT01702077 | Completed

• 2 other identifiers: 0206017435R01MH095789
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Tourette Syndrome; Chronic Tic Disorder

Keywords

neurofeedback; biofeedback; real-time fMRI; rt-fMRI; functional connectivity; fMRI

Outcome Measures

Primary Outcomes (2)

• 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 assessed approximately half a week PRIOR TO beginning biofeedback/sham feedback.

• 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 assessed approximately half a week AFTER completing biofeedback/sham feedback.

Secondary Outcomes (2)

• Control over target brain area

  Assessed approximately half a week BEFORE biofeedback/sham biofeedback.

• Control over target brain area

  Assessed approximately half a week AFTER biofeedback/sham biofeedback.

Other Outcomes (3)

• Functional connectivity patterns in the brain

  Assessed approximately half a week BEFORE biofeedback/sham biofeedback.

• Functional connectivity patterns in the brain

  Assessed approximately half a week AFTER biofeedback/sham biofeedback.

• Clinical improvement

  Clinical improvement will be assessed approximately half a week AFTER biofeedback/sham feedback

Study Arms (2)

Neurofeedback first

EXPERIMENTAL

Neurofeedback then sham feedback

Procedure: Neurofeedback; Procedure: Sham feedback

Sham first

EXPERIMENTAL

Sham feedback then neurofeedback

Procedure: Neurofeedback; Procedure: Sham feedback

Interventions

Neurofeedback PROCEDURE

Also known as: biofeedback, real-time fMRI biofeedback

Neurofeedback first; Sham first

Sham feedback PROCEDURE

Neurofeedback first; Sham first

Eligibility Criteria

• Age: 11 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Yale University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Tourette Syndrome; Tic Disorders

Interventions

Neurofeedback; Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Officials

• Michelle Hampson, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 5, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: August 27, 2018

Record last verified: 2018-08

Locations

US (1)