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CompletedNCT05628805Updated Mar 18, 2026

Theta Burst Stimulation to Improve Inhibitory Motor Physiology in Tourette Syndrome

An interventional study of iTBS in Tourette Syndrome, Tourette Syndrome in Children and Tourette Syndrome in Adolescence, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 10 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Children's Hospital Medical Center, Cincinnati · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
16
Allocation
Randomized
Ages
10 Years to 21 Years
Sex
All
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Study 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.

02

Conditions studied

  • Tourette Syndrome
  • Tourette Syndrome in Children
  • Tourette Syndrome in Adolescence
  • Tourette Syndrome, Modifier of

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03

In context

Tourette Syndrome

220 studies on the registry are indexed under Tourette Syndrome; 37 are open to participants now.

This study's enrollment of 16 is below the median of 34 across 166 interventional studies indexed under Tourette Syndrome.

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Lead sponsor

Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.

Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
10 Years to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Participants of any sex, race, or ethnicity meeting all criteria listed below will be included in the study:

  1. Aged 10-21 years
  2. Fluent in English
  3. DSM-5 diagnosis of TS, confirmed by the clinical team
  4. 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.
  5. 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

Exclusion Criteria:

  1. 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.
  2. Presence of metallic foreign bodies or implanted medical devices.
  3. Not meeting inclusion criteria as described above
  4. 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Double (Participant, Outcomes assessor)
Enrollment
16 participants (actual)

Study arms

  • Experimental
    iTBS

    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.

    Device: iTBS

  • Sham comparator
    Sham iTBS

    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.

    Device: iTBS

Interventions

  • DeviceiTBS

    intermittent theta burst stimulation with TMS

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What researchers measure

Primary outcomes

  1. change in cortical silent period (cSP)

    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

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Study locations

1 site
  • Cincinnati Children's Hospital Medical Center
    Cincinnati, Ohio 45229, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05628805
Lead sponsor
Children's Hospital Medical Center, Cincinnati
Collaborators
Tourette Association of America
Responsible party
Travis Larsh (Assistant Professor, Children's Hospital Medical Center, Cincinnati) — Principal investigator
First posted
Nov 29, 2022
Start date
Nov 1, 2022
Primary completion
Feb 16, 2026
Completion
Feb 16, 2026
Last update
Mar 18, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.

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