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Neurofeedback From the Supplementary Motor Area for Tourette Syndrome

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ClinicalTrials.gov Identifier: NCT05558566
Recruitment Status : Recruiting
First Posted : September 28, 2022
Last Update Posted : November 23, 2022
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Yale University

Study Description
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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).

Condition or disease Intervention/treatment Phase
Tourette Syndrome in Adolescence Other: Neurofeedback from the SMA Other: Neurofeedback from control region Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neurofeedback From the Supplementary Motor Area for Tourette Syndrome
Actual Study Start Date : November 1, 2022
Estimated Primary Completion Date : December 20, 2026
Estimated Study Completion Date : January 20, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.


Eligibility Criteria
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Ages Eligible for Study:   10 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Boys and girls, 10 to 16 years of age
  • A current diagnosis of Tourette Syndrome (TS) or chronic tic disorder, with active tics that can be executed without head movement, and a YGTSS score of at least 13
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05558566


Contacts
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Contact: Cheyenne Harris-Starling 203-737-6055 cheyenne.harris-starling@yale.edu
Contact: Jitendra Awasti 203-737-6055 jitendra.awasti@yale.edu

Locations
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United States, Connecticut
Yale University School of Medicine Recruiting
New Haven, Connecticut, United States, 06520
Principal Investigator: Michelle Hampson, PhD         
Sponsors and Collaborators
Yale University
National Institute of Mental Health (NIMH)
Investigators
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Principal Investigator: Michelle Hampson, PhD Yale University
More Information
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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT05558566    
Other Study ID Numbers: 2000033043
1R01MH127147-01A1 ( U.S. NIH Grant/Contract )
First Posted: September 28, 2022    Key Record Dates
Last Update Posted: November 23, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be uploaded to the National Institute of Mental Health Data Archive (NDA) and made available to other researchers.
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tourette Syndrome
Syndrome
Disease
Pathologic Processes
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tic Disorders
Movement Disorders
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Genetic Diseases, Inborn
Neurodevelopmental Disorders
Mental Disorders