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).

Study Overview

• Status: Recruiting
• Conditions: Tourette Syndrome in Adolescence
• Intervention / Treatment: Other: Neurofeedback from the SMA; Other: Neurofeedback from control region

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Cheyenne Harris-Starling; Phone Number: 203-737-6055; Email: cheyenne.harris-starling@yale.edu
• Study Contact Backup: Name: Jitendra Awasti; Phone Number: 203-737-6055; Email: jitendra.awasti@yale.edu

Study Locations

• United States
  • Connecticut
    • New Haven, Connecticut, United States, 06520
      • Recruiting
      • Yale University School of Medicine
      • Principal Investigator: Michelle Hampson, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 16 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Neurofeedback from the SMA	Other: Neurofeedback from the SMA; Feedback is provided regarding activity in the SMA and participant attempts to control SMA activity using the feedback as a training signal
Active Comparator: Neurofeedback from control region	Other: Neurofeedback from control region; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in control over activity in the SMA target region during NF compared to baseline	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).	Baseline and during NF

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in resting state functional connectivity to SMA in NF group	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.	Baseline and one month post-NF

Collaborators and Investigators

• Sponsor: Yale University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Michelle Hampson, PhD, Yale University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): December 20, 2026
• Study Completion (Estimated): January 20, 2027

Study Registration Dates

• First Submitted: September 21, 2022
• First Submitted That Met QC Criteria: September 23, 2022
• First Posted (Actual): September 28, 2022

Study Record Updates

• Last Update Posted (Actual): October 4, 2023
• Last Update Submitted That Met QC Criteria: October 3, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Disease; Genetic Diseases, Inborn; Basal Ganglia Diseases; Movement Disorders; Neurodegenerative Diseases; Heredodegenerative Disorders, Nervous System; Neurodevelopmental Disorders; Tic Disorders; Syndrome; Tourette Syndrome
• Other Study ID Numbers: 2000033043; 1R01MH127147-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be uploaded to the National Institute of Mental Health Data Archive (NDA) and made available to other researchers.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No