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Non-invasive Brain Stimulation

Theta Burst Stimulation for Tourette Syndrome

Q: Is registration for this clinical trial still available?

Affirmative, clinicaltrials.gov's records demonstrate that this medical trial is actively recruiting patients as of now. This study was initially posted on November 1st 2022 and its latest edition occurred on November 23rd 2022. The research requires 30 participants to be enrolled at a single site.

Q: Is this clinical trial open to all individuals, or are there certain eligibility criteria?

Applicants for this trial must be between 10 and 21 years old with a diagnosis of gilles de la <a href="https://www.withpower.com/clinical-trials/tourette-syndrome">tourette syndrome</a>. A total of 30 candidates are being sought after to participate in the study.

Q: What is the aggregate enrollment for this scientific investigation?

Indeed, the information on clinicaltrials.gov affirms that this trial is in search of volunteers. The study was initially published on November 1st 2022 and has been recently updated as of November 23rd 2022. This examination requires 30 participants at one site to begin.

Q: Does this research incorporate individuals who are elderly?

Patients who meet the trial's inclusion criteria must be between 10 and 21 years old. Notably, there are 382 trials recruiting patients under 18 while 990 recruit those over 65.

Phase < 1

Recruiting

Research Sponsored by Children's Hospital Medical Center, Cincinnati

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up on the same day, we will assess change in csp prior to active (or sham) itbs treatment and immediately after itbs treatment

Awards & highlights

Study Summary

This trial proposes using a non-invasive technology to modulate brain circuits in order to reduce tics in Tourette Syndrome patients.

Who is the study for?

This trial is for young people aged 10-21 with Tourette Syndrome (TS) who speak English and can understand the study. They should be clinically stable, meaning no recent changes in their psychotropic medications or other therapies. Participants must not have any metal in their body or certain psychiatric conditions beyond TS, ADHD, OCD, or mild anxiety.Check my eligibility

What is being tested?

The trial tests a non-invasive brain stimulation technique called intermittent theta-burst repetitive TMS (iTBS). It's designed to improve motor control by targeting a specific part of the brain involved in movement regulation. The study compares real iTBS treatment to a sham (fake) procedure to see if it can reduce tics in TS patients.See study design

What are the potential side effects?

While iTBS is generally considered safe, potential side effects may include discomfort at the stimulation site on the scalp, headache, lightheadedness, or seizures; however these are rare. The actual experience of side effects varies from person to person.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ on the same day, we will assess change in csp prior to active (or sham) itbs treatment and immediately after itbs treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~on the same day, we will assess change in csp prior to active (or sham) itbs treatment and immediately after itbs treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and on the same day, we will assess change in csp prior to active (or sham) itbs treatment and immediately after itbs treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

change in cortical silent period (cSP)

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: iTBSExperimental Treatment1 Intervention

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.

Group II: Sham iTBSPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

iTBS

2019

Completed Phase 3

~640

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Tourette Association of AmericaOTHER

11 Previous Clinical Trials

496 Total Patients Enrolled

11 Trials studying Tourette Syndrome

496 Patients Enrolled for Tourette Syndrome

Children's Hospital Medical Center, CincinnatiLead Sponsor

815 Previous Clinical Trials

6,531,561 Total Patients Enrolled

3 Trials studying Tourette Syndrome

96 Patients Enrolled for Tourette Syndrome

Media Library

iTBS (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05628805 — Phase < 1

Tourette Syndrome Research Study Groups: iTBS, Sham iTBS

Tourette Syndrome Clinical Trial 2023: iTBS Highlights & Side Effects. Trial Name: NCT05628805 — Phase < 1

iTBS (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05628805 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is registration for this clinical trial still available?

"Affirmative, clinicaltrials.gov's records demonstrate that this medical trial is actively recruiting patients as of now. This study was initially posted on November 1st 2022 and its latest edition occurred on November 23rd 2022. The research requires 30 participants to be enrolled at a single site."

Answered by AI

Is this clinical trial open to all individuals, or are there certain eligibility criteria?

"Applicants for this trial must be between 10 and 21 years old with a diagnosis of gilles de la tourette syndrome. A total of 30 candidates are being sought after to participate in the study."

Answered by AI

What is the aggregate enrollment for this scientific investigation?

"Indeed, the information on clinicaltrials.gov affirms that this trial is in search of volunteers. The study was initially published on November 1st 2022 and has been recently updated as of November 23rd 2022. This examination requires 30 participants at one site to begin."

Answered by AI

Does this research incorporate individuals who are elderly?

"Patients who meet the trial's inclusion criteria must be between 10 and 21 years old. Notably, there are 382 trials recruiting patients under 18 while 990 recruit those over 65."

Answered by AI