RECRUITING

Theta Burst Stimulation to Improve Inhibitory Motor Physiology in Tourette Syndrome

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Theta Burst Stimulation to Improve Inhibitory Motor Physiology in Tourette Syndrome

Quick Facts

Study Start:2022-11-01

Study Completion:2025-02-17

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05628805

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:10 Years to 21 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion Criteria
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.	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

Inclusion Criteria

Exclusion Criteria

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.

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

Contacts and Locations

Study Contact

Molly Griffith

CONTACT

513-636-9669

molly.griffith@cchmc.org

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-11-01

Study Completion Date2025-02-17

Study Record Updates

Study Start Date2022-11-01

Study Completion Date2025-02-17

Terms related to this study

Additional Relevant MeSH Terms

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