Neurofeedback From the Supplementary Motor Area for Tourette Syndrome

Last updated: August 9, 2024
Sponsor: Yale University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Autism

Tic Disorders

Treatment

Neurofeedback from control region

Neurofeedback from the SMA

Clinical Study ID

NCT05558566
2000033043
1R01MH127147-01A1
  • Ages 10-16
  • All Genders

Study Summary

This is a clinical trial where adolescents aged 10-16 years old with Tourette Syndrome (or chronic tic disorder) are randomized to receive either real-time functional magnetic resonance imaging (fMRI) neurofeedback targeting the supplementary motor area (for the experimental intervention) or real-time fMRI neurofeedback (NF) from a control region (for the control intervention).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Boys and girls, 10 to 16 years of age

  • A current diagnosis of Tourette Syndrome (TS) or chronic tic disorder (CTD), withactive tics that can be executed without head movement, and a YGTSS score of atleast 13 (for TS participants) or at least 12 (for CTD participants)

  • Currently stable medication treatment and no planned changes in medication for theduration of the study.

  • Family residence within 2 hours of Yale Medical Center with ability and willingnessto attend assessment and fMRI visits.

  • Children and their parents are expected to be able to speak and understand spokenEnglish in order to participate in a clinical assessment of TS and relatedpsychopathology.

  • Subjects will be free of: 1) metal medical implants or braces, 2) pregnancy, andwill have 3) a body weight of less than 250 lbs. and 4) no claustrophobia.

Exclusion

Exclusion Criteria:

  • Intelligence quotient below 80

  • Current diagnosis of autism spectrum disorder, bipolar or psychotic disorder orcurrent suicidality

  • Significant medical condition such as heart disease, hypertension, liver or renalfailure, pulmonary disease, seizure disorder

  • Recently initiated psychotherapy. Participation in the study will not be allowedwithin 8 weeks of the initiation of psychotherapy. Ongoing, concurrent psychotherapy (that was initiated at least 8 weeks previously) for the child will be allowed, butparents will be asked not to initiate any new psychotherapy for the child during thestudy

  • Subjects may also be excluded after the first MR scan if we are unable to localizethe two regions in their brain that are used as targets for the active and controlneurofeedback conditions.

Study Design

Total Participants: 64
Treatment Group(s): 2
Primary Treatment: Neurofeedback from control region
Phase:
Study Start date:
November 01, 2022
Estimated Completion Date:
January 20, 2027

Study Description

The training portion of this study involves three fMRI NF sessions, with six NF scans per session. NF scans alternate between up-regulate and down-regulate blocks in which participants are cued to increase or decrease activity in the target region while receiving feedback on activity in the region at the bottom of the screen in the form of a line graph. The experimental group receives feedback from the supplementary motor area (SMA) and the control group receives feedback from a control region of the brain.

Connect with a study center

  • Yale University School of Medicine

    New Haven, Connecticut 06520
    United States

    Active - Recruiting

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