What side effects are associated with this type of intervention?

Common treatments for Tourette Syndrome, particularly neuromodulation techniques like repetitive transcranial magnetic stimulation (rTMS) and intermittent theta-burst stimulation (iTBS), generally have mild side effects. These can include headaches, scalp discomfort at the stimulation site, and transient mood changes. Serious adverse events are rare. Other treatments for Tourette Syndrome, such as medications, may have side effects including sedation, weight gain, and metabolic changes. Overall, neuromodulation techniques are considered relatively safe with a favorable side effect profile compared to pharmacological treatments.

What prior FDA approvals exist?

The FDA has approved several medications for the treatment of Tourette Syndrome, including antipsychotics like haloperidol and pimozide, and alpha-2 adrenergic agonists such as clonidine and guanfacine. These medications primarily target neurotransmitter pathways to reduce tics. While neuromodulation techniques like repetitive transcranial magnetic stimulation (rTMS) and its variant, Intermittent Theta-Burst Stimulation (iTBS), are being studied for their potential to enhance neuroplasticity and improve motor inhibition, they are not yet FDA-approved for Tourette Syndrome. These techniques offer a non-invasive alternative that could complement or replace pharmacologic treatments in the future.

What other types of research exist?

Promising, novel alternatives to iTBS for Tourette Syndrome patients include: 1) Repetitive Transcranial Magnetic Stimulation (rTMS), which has been used to modulate brain circuits in various neuropsychiatric disorders. 2) Transcranial Direct Current Stimulation (tDCS), which has shown potential in enhancing neurocognition and modulating brain activity. 3) Deep Brain Stimulation (DBS), although more invasive, has been effective in treatment-resistant cases of other movement disorders. 4) Cranial Electrotherapy Stimulation (CES), which has shown safety and efficacy in mood disorders and may offer benefits for TS.

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Non-invasive Brain Stimulation

Theta Burst Stimulation for Tourette Syndrome

Q: What is the mechanism of action of this treatment?

The most common treatments for Tourette Syndrome include pharmacotherapy and neuromodulation techniques. Neuromodulation, such as Intermittent Theta-Burst Stimulation (iTBS), works by modulating brain circuits through the concept of neuroplasticity. iTBS specifically targets the pre-supplementary motor area (pre-SMA) to enhance motor inhibition, which is crucial for reducing tics in Tourette Syndrome patients. This matters because improving inhibitory control can lead to a significant reduction in the frequency and severity of tics, thereby improving the quality of life for patients.

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

Summary

This trial uses a non-invasive magnetic pulse therapy to help Tourette Syndrome patients by improving their brain's ability to control movements and reduce tics. This therapy has shown promising results in reducing tic severity in Tourette Syndrome.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Tourette Syndrome include pharmacotherapy and neuromodulation techniques. Neuromodulation, such as Intermittent Theta-Burst Stimulation (iTBS), works by modulating brain circuits through the concept of neuroplasticity. iTBS specifically targets the pre-supplementary motor area (pre-SMA) to enhance motor inhibition, which is crucial for reducing tics in Tourette Syndrome patients. This matters because improving inhibitory control can lead to a significant reduction in the frequency and severity of tics, thereby improving the quality of life for patients.

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