Neurofeedback From the Supplementary Motor Area for Tourette Syndrome
Primary Purpose
Tourette Syndrome in Adolescence
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Neurofeedback from the SMA
Neurofeedback from control region
Sponsored by
About this trial
This is an interventional treatment trial for Tourette Syndrome in Adolescence
Eligibility 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 defined by: no new medication, no dose increases of ongoing medication, or medication discontinuation for 8 weeks prior to randomization; 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
Sites / Locations
- Yale University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Neurofeedback from the SMA
Neurofeedback from control region
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT05558566
First Posted
September 21, 2022
Last Updated
October 3, 2023
Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
1. Study Identification
Unique Protocol Identification Number
NCT05558566
Brief Title
Neurofeedback From the Supplementary Motor Area for Tourette Syndrome
Official Title
Neurofeedback From the Supplementary Motor Area for Tourette Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 20, 2026 (Anticipated)
Study Completion Date
January 20, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Mental Health (NIMH)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome in Adolescence
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Neurofeedback from the SMA
Arm Type
Experimental
Arm Title
Neurofeedback from control region
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Neurofeedback from the SMA
Intervention Description
Feedback is provided regarding activity in the SMA and participant attempts to control SMA activity using the feedback as a training signal
Intervention Type
Other
Intervention Name(s)
Neurofeedback from control region
Intervention Description
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 Outcome Measure Information:
Title
Change in symptoms after the intervention compared to baseline
Description
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.
Time Frame
Baseline, 4 days post-NF, 2 weeks post-NF, and 1 month post-NF
Secondary Outcome Measure Information:
Title
Change in control over activity in the SMA target region during NF compared to baseline
Description
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).
Time Frame
Baseline and during NF
Other Pre-specified Outcome Measures:
Title
Changes in resting state functional connectivity to SMA in NF group
Description
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.
Time Frame
Baseline and one month post-NF
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheyenne Harris-Starling
Phone
203-737-6055
Email
cheyenne.harris-starling@yale.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jitendra Awasti
Phone
203-737-6055
Email
jitendra.awasti@yale.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michelle Hampson, PhD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Hampson, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Neurofeedback From the Supplementary Motor Area for Tourette Syndrome
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