Neurofeedback From the Supplementary Motor Area for Tourette Syndrome

Tourette Syndrome in Adolescence Clinical Trial

Official title:

Neurofeedback From the Supplementary Motor Area for Tourette Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05558566
• Other study ID #: 2000033043
• Secondary ID: 1R01MH127147-01A
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2022
• Est. completion date: January 20, 2027

Study information

• Verified date: October 2023
• Source: Yale University
• Contact: Cheyenne Harris-Starling
• Phone: 203-737-6055
• Email: cheyenne.harris-starling[@]yale.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 64
• Est. completion date: January 20, 2027
• Est. primary completion date: December 20, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Syndrome
• Tourette Syndrome
• Tourette Syndrome in Adolescence

Intervention

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
• 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.

Locations

Country	Name	City	State
United States	Yale University School of Medicine	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Primary	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	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