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Theta Burst Stimulation to Improve Inhibitory Motor Physiology in Tourette Syndrome

Primary Purpose

Tourette Syndrome, Tourette Syndrome in Children, Tourette Syndrome in Adolescence

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
iTBS
Sponsored by
Children's Hospital Medical Center, Cincinnati
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tourette Syndrome

Eligibility Criteria

10 Years - 21 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Participants of any sex, race, or ethnicity meeting all criteria listed below will be included in the study: Aged 10-21 years Fluent in English DSM-5 diagnosis of TS, confirmed by the clinical team Able to participate in the informed consent process, provide voluntary informed consent/assent and provide a spontaneous narrative description of the key elements of the study. Clinical stability: determined by a physician, no switch of psychotropic medications or increase in dosage in the last 14 days from TMS treatment start; no change in other therapeutic interventions in last 14 days from TMS treatment start. Exclusion Criteria: Any neurodevelopmental, psychiatric condition other than TS, ADHD, or OCD, or mild anxiety based on review of K-SADS. Note - if an exclusionary psychiatric diagnosis is suspected based on K-SADS, the research physician will follow up with the parent and referral will be made to psychology or psychiatry as appropriate. Presence of metallic foreign bodies or implanted medical devices. Not meeting inclusion criteria as described above Non-fluency in English, as English is the language in the validated clinical questionnaires, and the participant must be able to understand real-time instructions from the study staff

Sites / Locations

  • Cincinnati Children's Hospital Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

iTBS

Sham iTBS

Arm Description

Each participant will have two separate study days in the TMS lab. On one day, the participant will receive active pre-SMA iTBS. On the other day, the patricipant will receive sham pre-SMA iTBS. The order that active versus sham is given will be randomized and the participant will be blinded. After each iTBS session, blinding assessment will be performed. To avoid contamination of results, a minimum of 5 days between study days will be required.

Each participant will have two separate study days in the TMS lab. On one day, the participant will receive active pre-SMA iTBS. On the other day, the patricipant will receive sham pre-SMA iTBS. The order that active versus sham is given will be randomized and the participant will be blinded. After each iTBS session, blinding assessment will be performed. To avoid contamination of results, a minimum of 5 days between study days will be required.

Outcomes

Primary Outcome Measures

change in cortical silent period (cSP)
cSP is a biomarker of inhibitory motor physiology

Secondary Outcome Measures

Full Information

First Posted
November 8, 2022
Last Updated
November 23, 2022
Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Tourette Association of America
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1. Study Identification

Unique Protocol Identification Number
NCT05628805
Brief Title
Theta Burst Stimulation to Improve Inhibitory Motor Physiology in Tourette Syndrome
Official Title
Theta Burst Stimulation to Improve Inhibitory Motor Physiology in Tourette Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Tourette Association of America

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Decades of Tourette Syndrome (TS) neuroimaging research has revealed abnormal cortical and subcortical motor system network, hypothesized to result from maladaptive plasticity. Repetitive transcranial magnetic stimulation ([r]TMS) is a promising technology that utilizes the concept of neuroplasticity to modulate brain circuits. TMS modulation has the distinct advantage in terms of its non-invasive nature. Furthermore, unique stimulation paradigms such as intermittent theta-burst repetitive TMS (iTBS) allows for short stimulation time (<3 min). Using a sham-controlled protocol, the investigators propose modulating pre-SMA output using iTBS, based on our prior data of abnormal pre-SMA-mediated motor system regulation. hypothesize pre-SMA modulation results in increased pre-SMA-mediated motor inhibition. Enhancing these inhibitory measures with pre-SMA-iTBS provides the basis for improving inhibitory function in TS patients, leading to our long-term goal of neuro-stimulation to achieve clinical tic reduction.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tourette Syndrome, Tourette Syndrome in Children, Tourette Syndrome in Adolescence, Tourette Syndrome, Modifier of

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
iTBS
Arm Type
Experimental
Arm Description
Each participant will have two separate study days in the TMS lab. On one day, the participant will receive active pre-SMA iTBS. On the other day, the patricipant will receive sham pre-SMA iTBS. The order that active versus sham is given will be randomized and the participant will be blinded. After each iTBS session, blinding assessment will be performed. To avoid contamination of results, a minimum of 5 days between study days will be required.
Arm Title
Sham iTBS
Arm Type
Sham Comparator
Arm Description
Each participant will have two separate study days in the TMS lab. On one day, the participant will receive active pre-SMA iTBS. On the other day, the patricipant will receive sham pre-SMA iTBS. The order that active versus sham is given will be randomized and the participant will be blinded. After each iTBS session, blinding assessment will be performed. To avoid contamination of results, a minimum of 5 days between study days will be required.
Intervention Type
Device
Intervention Name(s)
iTBS
Intervention Description
intermittent theta burst stimulation with TMS
Primary Outcome Measure Information:
Title
change in cortical silent period (cSP)
Description
cSP is a biomarker of inhibitory motor physiology
Time Frame
On the same day, we will assess change in cSP prior to active (or sham) iTBS treatment and immediately after iTBS treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants of any sex, race, or ethnicity meeting all criteria listed below will be included in the study: Aged 10-21 years Fluent in English DSM-5 diagnosis of TS, confirmed by the clinical team Able to participate in the informed consent process, provide voluntary informed consent/assent and provide a spontaneous narrative description of the key elements of the study. Clinical stability: determined by a physician, no switch of psychotropic medications or increase in dosage in the last 14 days from TMS treatment start; no change in other therapeutic interventions in last 14 days from TMS treatment start. Exclusion Criteria: Any neurodevelopmental, psychiatric condition other than TS, ADHD, or OCD, or mild anxiety based on review of K-SADS. Note - if an exclusionary psychiatric diagnosis is suspected based on K-SADS, the research physician will follow up with the parent and referral will be made to psychology or psychiatry as appropriate. Presence of metallic foreign bodies or implanted medical devices. Not meeting inclusion criteria as described above Non-fluency in English, as English is the language in the validated clinical questionnaires, and the participant must be able to understand real-time instructions from the study staff
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Molly Griffith
Phone
513-636-9669
Email
molly.griffith@cchmc.org
Facility Information:
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karlee Migneault
Phone
513-803-5299
Email
karlee.migneault@cchmc.org
First Name & Middle Initial & Last Name & Degree
Travis R Larsh, MD
First Name & Middle Initial & Last Name & Degree
Steve W Wu, MD
First Name & Middle Initial & Last Name & Degree
Ernest V Pedapati, MD MS
First Name & Middle Initial & Last Name & Degree
Donald L Gilbert, MD MS
First Name & Middle Initial & Last Name & Degree
Paul S Horn, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Theta Burst Stimulation to Improve Inhibitory Motor Physiology in Tourette Syndrome

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