Neurofeedback for Tourette Syndrome

NCT ID: NCT01702077

Last Updated: 2018-08-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-31

Study Completion Date

2017-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Tourette Syndrome Chronic Tic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Sham first

Sham feedback then neurofeedback

Group Type EXPERIMENTAL

Neurofeedback

Intervention Type PROCEDURE

Sham feedback

Intervention Type PROCEDURE

Neurofeedback first

Neurofeedback then sham feedback

Group Type EXPERIMENTAL

Neurofeedback

Intervention Type PROCEDURE

Sham feedback

Intervention Type PROCEDURE

Interventions

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Neurofeedback

Intervention Type PROCEDURE

Sham feedback

Intervention Type PROCEDURE

Other Intervention Names

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biofeedback real-time fMRI biofeedback

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michelle Hampson, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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R01MH095789

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0206017435

Identifier Type: -

Identifier Source: org_study_id

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