Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05558566

Neurofeedback From the Supplementary Motor Area for Tourette Syndrome

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).

Recruiting

Interested in participating?

Request Info

Key information

Age range

10 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yale University School of Medicine

New Haven, Connecticut, 06520, United States

Location status: Recruiting

Location contact

Michelle Hampson, PhD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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 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.

Primary outcomes

  1. Change in symptoms after the intervention compared to baseline

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

    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.

Secondary outcomes

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

    Time frame: Baseline and during NF

    Control over the SMA is computed as the difference in the blood-oxygenation-level-dependent (BOLD) signal in SMA during up-regulate compared to down-regulate blocks. This measure is computed both in the NF scans and in the control task scans prior to the start of NF. Improvement in control for each subject is the difference of these two (i.e., control during NF minus control during pre-intervention control task scans).

Other outcomes

  1. Changes in resting state functional connectivity to SMA in NF group

    Time frame: Baseline and one month post-NF

    Functional connectivity is measured as temporal synchrony in the BOLD data in functional scans in which participants are just resting in the scanner. These scans are collected at baseline and one month after the neurofeedback training. Connectivity to the SMA will be computed for each time point and the change in the neurofeedback group will be examined and correlated with symptom improvement.

Study contacts

Contact information is provided by the study sponsor or research team.

Cheyenne Harris-Starling

CONTACT

[email protected]

203-737-6055

Jitendra Awasti

CONTACT

[email protected]

203-737-6055

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Sep 28, 2022
Registry last updated
Jun 9, 2026

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.

Published trials that share one or more normalized conditions with this study.