12 Participants Needed

TMS for Cerebellar Ataxia

AS
GL
Overseen ByGrace Loscalzo
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Albert Einstein Healthcare Network
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment TMS for cerebellar ataxia?

Research shows that repetitive transcranial magnetic stimulation (rTMS) can improve symptoms of cerebellar ataxia, such as balance and coordination, without significant negative effects. Studies found that rTMS improved scores on tests measuring ataxia severity and postural control, suggesting it could be a promising treatment option.12345

Is transcranial magnetic stimulation (TMS) safe for humans?

Transcranial magnetic stimulation (TMS), including repetitive TMS (rTMS), is generally considered safe for humans, with studies showing only a slight risk of seizures and mild side effects. Research on various conditions, including Parkinson's disease and cerebellar ataxia, indicates that rTMS does not result in significant adverse events, making it a promising and safe technique for treatment.12467

How does the treatment TMS differ from other treatments for cerebellar ataxia?

Transcranial Magnetic Stimulation (TMS) is unique because it is a non-invasive treatment that uses magnetic fields to stimulate the brain, specifically targeting the cerebellum to improve symptoms of cerebellar ataxia. Unlike traditional drug therapies, TMS does not involve medication and has shown promise in improving balance and coordination without significant adverse effects.12489

What is the purpose of this trial?

This trial aims to see if brain activity can predict and improve motor learning in people with cerebellar ataxia. It uses non-invasive brain stimulation to adjust brain activity and tests if this helps patients learn new movement skills better.

Research Team

AS

Amanda S Therrien, PhD

Principal Investigator

Moss Rehabilitation Research Institute

Eligibility Criteria

This trial is for individuals with cerebellar ataxia due to cerebellar degeneration. Participants must have normal or corrected vision and hearing, and meet safety criteria for transcranial magnetic stimulation (TMS). They cannot join if they have drug abuse history, sensory loss in arms, cognitive issues affecting testing or consent, or arm injuries causing pain.

Inclusion Criteria

I am cleared to receive brain stimulation treatment.
My vision is normal or corrected to normal with glasses or contacts.
My hearing is normal or corrected to normal.
See 1 more

Exclusion Criteria

I have unusual movements or symptoms like Parkinson's.
I can understand and follow instructions without any cognitive issues.
You have a history of drinking too much alcohol or using illegal drugs.
See 2 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

TMS is used to assess baseline recruitment curves for corticomotor excitability and short-interval intracortical inhibition, and the cortical silent period. Participants complete a standardized clinical rating of their ataxia severity and a behavioral task using the RL paradigm.

1 session
1 visit (in-person)

Intervention

Participants receive cTBS, iTBS, or sham stimulation to modulate intracortical inhibition in M1 prior to performing the RL task. This phase includes 3 sessions of the RL task.

6 months
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • TMS
Trial Overview The study aims to see if the activity level in the primary motor cortex can predict how well people with cerebellar damage learn motor skills. It also tests whether using TMS to change motor cortex activity improves their ability to learn new movements.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: rTMS InterventionExperimental Treatment1 Intervention
In aim 2 of the study, participants receive a repetitive transcranial magnetic stimulation intervention called theta burst stimulation (TBS) to study its effect on motor learning behavior. All participants will complete 3 sessions in which they will receive continuous TBS, intermittent TBS, or sham TBS before completing a behavioral motor learning task. The order of TBS sessions will be counter-balanced across participants.

TMS is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Transcranial Magnetic Stimulation for:
  • Depression
  • Anxiety disorders
  • Post-traumatic stress disorder (PTSD)
  • Obsessive-compulsive disorder (OCD)
🇪🇺
Approved in European Union as Transcranial Magnetic Stimulation for:
  • Depression
  • Anxiety disorders
  • Post-traumatic stress disorder (PTSD)
  • Obsessive-compulsive disorder (OCD)
🇨🇦
Approved in Canada as Transcranial Magnetic Stimulation for:
  • Depression
  • Anxiety disorders
  • Post-traumatic stress disorder (PTSD)
  • Obsessive-compulsive disorder (OCD)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Albert Einstein Healthcare Network

Lead Sponsor

Trials
65
Recruited
869,000+

Medical University of South Carolina

Collaborator

Trials
994
Recruited
7,408,000+

Findings from Research

A review of 84 single pulse and paired-pulse TMS studies with 1091 Parkinson's disease patients, and 77 repetitive TMS studies with 1137 patients, found a very low risk of adverse events, with no seizures reported.
The overall risk of adverse events from rTMS was 0.040 per patient, with common side effects being mild and transient, such as headaches and scalp pain, indicating that TMS is generally safe for Parkinson's patients.
Safety of transcranial magnetic stimulation in Parkinson's disease: a review of the literature.Vonloh, M., Chen, R., Kluger, B.[2021]

References

Reduced intracortical facilitation in patients with cerebellar degeneration. [2019]
Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation in Cerebellar Ataxia: a Systematic Review and Meta-analysis. [2023]
Cerebellar TMS in treatment of a patient with cerebellar ataxia: evidence from clinical, biomechanics and neurophysiological assessments. [2021]
Repetitive Transcranial Magnetic Stimulation in Spinocerebellar Ataxia: A Pilot Randomized Controlled Trial. [2020]
Effectiveness of High-Frequency Repetitive Transcranial Magnetic Stimulation in Patients With Spinocerebellar Ataxia Type 3. [2023]
Safety of transcranial magnetic stimulation in Parkinson's disease: a review of the literature. [2021]
The Effect of Cerebellar rTMS on Modulating Motor Dysfunction in Neurological Disorders: a Systematic Review. [2023]
Bilateral Cerebellar Repetitive Transcranial Magnetic Stimulation for Chronic Ataxia After Hemorrhagic Stroke: a Case Report. [2023]
9.United Arab Emiratespubmed.ncbi.nlm.nih.gov
Noninvasive Cerebellar Stimulation as a Complement Tool to Pharmacotherapy. [2020]
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