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Completed

NCT Number: NCT01702077

Neurofeedback for Tourette Syndrome

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.

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Key information

Conditions

Tourette Syndrome Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Chronic Tic Disorder Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Heredodegenerative Disorders, Nervous System Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Neurodevelopmental Disorders Tic Disorders

Age range

11 year–19 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Neurofeedback

Procedure

Other names: biofeedback, real-time fMRI biofeedback

Sham feedback

Procedure

Primary outcomes

  1. Tic severity

    Time frame: Tic severity assessed approximately half a week PRIOR TO beginning biofeedback/sham feedback.

    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.

  2. Tic severity

    Time frame: Tic severity assessed approximately half a week AFTER completing biofeedback/sham feedback.

    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 outcomes

  1. Control over target brain area

    Time frame: Assessed approximately half a week BEFORE biofeedback/sham biofeedback.

    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.

  2. Control over target brain area

    Time frame: Assessed approximately half a week AFTER biofeedback/sham biofeedback.

    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 outcomes

  1. Functional connectivity patterns in the brain

    Time frame: Assessed approximately half a week BEFORE biofeedback/sham biofeedback.

    Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.

  2. Functional connectivity patterns in the brain

    Time frame: Assessed approximately half a week AFTER biofeedback/sham biofeedback.

    Functional connectivity will be assessed based on temporal correlations in resting state functional imaging data.

  3. Clinical improvement

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

    The Clinical Global Impression - Improvement scale will be used to assess improvement over the course of the biofeedback/sham feedback

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

Neurofeedback of Activity in the Supplementary Motor Area for Tourette Syndrome

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Oct 5, 2012
Registry last updated
Aug 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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