Neurofeedback From the Supplementary Motor Area for Tourette Syndrome

NCT05558566 | Recruiting DMC

• 2 other identifiers: 20000330431R01MH127147-01A1
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Tourette Syndrome in Adolescence

Outcome Measures

Primary Outcomes (1)

• Change in symptoms after the intervention compared to baseline

  Symptom severity is assessed using the Yale Global Tic Severity Scale (YGTSS) before NF and at several time points in the month following the completion of NF training.

  Baseline, 4 days post-NF, 2 weeks post-NF, and 1 month post-NF

Secondary Outcomes (1)

• Change in control over activity in the SMA target region during NF compared to baseline

  Baseline and during NF

Other Outcomes (1)

• Changes in resting state functional connectivity to SMA in NF group

  Baseline and one month post-NF

Study Arms (2)

Neurofeedback from the SMA

EXPERIMENTAL

Other: Neurofeedback from the SMA

Neurofeedback from control region

ACTIVE COMPARATOR

Other: Neurofeedback from control region

Interventions

Neurofeedback from the SMA OTHER

Feedback is provided regarding activity in the SMA and participant attempts to control SMA activity using the feedback as a training signal

Neurofeedback from the SMA

Neurofeedback from control region OTHER

Feedback is provided regarding activity in a control region and participant attempts to control activity in that region using the feedback as a training signal.

Neurofeedback from control region

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Boys and girls, 10 to 16 years of age
• A current diagnosis of Tourette Syndrome (TS) or chronic tic disorder (CTD), with active tics that can be executed without head movement, and a YGTSS score of at least 13 (for TS participants) or at least 12 (for CTD participants)
• Currently stable medication treatment and no planned changes in medication for the duration of the study.
• Family residence within 2 hours of Yale Medical Center with ability and willingness to attend assessment and fMRI visits.
• Children and their parents are expected to be able to speak and understand spoken English in order to participate in a clinical assessment of TS and related psychopathology.
• Subjects will be free of: 1) metal medical implants or braces, 2) pregnancy, and will have 3) a body weight of less than 250 lbs. and 4) no claustrophobia.

You may not qualify if:

• Intelligence quotient below 80
• Current diagnosis of autism spectrum disorder, bipolar or psychotic disorder or current suicidality
• Significant medical condition such as heart disease, hypertension, liver or renal failure, pulmonary disease, seizure disorder
• Recently initiated psychotherapy. Participation in the study will not be allowed within 8 weeks of the initiation of psychotherapy. Ongoing, concurrent psychotherapy (that was initiated at least 8 weeks previously) for the child will be allowed, but parents will be asked not to initiate any new psychotherapy for the child during the study
• Subjects may also be excluded after the first MR scan if we are unable to localize the two regions in their brain that are used as targets for the active and control neurofeedback conditions.

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

RECRUITING

Study Officials

• Michelle Hampson, PhD

  Yale University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheyenne Harris-Starling

CONTACT

203-737-6055; cheyenne.harris-starling@yale.edu

Jitendra Awasti

CONTACT

203-737-6055; jitendra.awasti@yale.edu

Study Design

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

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 28, 2022
• Study Start: November 1, 2022
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): January 20, 2027
• Last Updated: August 6, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data are uploaded every 6 months to NDA during the trial. Demographic and baseline data are released by NDA four months after upload. Outcome measures are released by NDA upon publication.

Locations

US (1)