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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a type of non-invasive brain stimulation, called TMS (transcranial magnetic stimulation), can help individuals with cerebellar ataxia, a condition affecting movement and balance. Researchers aim to determine if this treatment can enhance motor learning, which involves learning and performing new movements. Participants will undergo various TMS sessions and a sham session to assess their impact on motor task learning. Individuals diagnosed with cerebellar ataxia due to cerebellar degeneration, who have normal vision and hearing, are well-suited for this trial. As an unphased trial, this study offers a chance to contribute to groundbreaking research that could lead to new treatment options for cerebellar ataxia.

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 prior data suggests that TMS is safe for individuals with cerebellar ataxia?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) is a safe and noninvasive brain treatment. Studies indicate it can help with brain conditions like Parkinson's and Alzheimer's. It may also improve movement problems in people with cerebellar ataxia, a disorder affecting coordination.

In clinical trials, patients with cerebellar ataxia who received rTMS experienced noticeable improvements, suggesting the treatment is well-tolerated. These studies did not report any severe side effects, which is encouraging.

Overall, rTMS has been tested in many settings and is considered safe. While more research is ongoing, current evidence supports its safety.12345

Why are researchers excited about this trial?

Researchers are excited about the use of repetitive transcranial magnetic stimulation (rTMS) for cerebellar ataxia because it offers a non-invasive approach that directly targets brain activity, which is different from traditional medications. While most treatments for cerebellar ataxia focus on managing symptoms through drugs or physical therapy, rTMS uses magnetic fields to stimulate specific areas of the brain, potentially improving motor learning and coordination. This technique, particularly the theta burst stimulation (TBS) variant, could provide faster and more targeted improvements in motor function, offering new hope where current therapies have limitations.

What evidence suggests that TMS is effective for cerebellar ataxia?

Research has shown that repetitive transcranial magnetic stimulation (rTMS) can greatly improve symptoms in people with cerebellar ataxia. Studies have found that rTMS, a non-invasive method using magnetic fields to stimulate the brain, can have lasting positive effects on various neurological conditions, including ataxia. In this trial, participants will receive different forms of rTMS—continuous TBS, intermittent TBS, or sham TBS—to study its effect on motor learning behavior. While the level of improvement can differ, rTMS is generally considered a safe and promising way to reduce ataxia symptoms.15678

Who Is on the Research Team?

AS

Amanda S Therrien, PhD

Principal Investigator

Moss Rehabilitation Research Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: rTMS InterventionExperimental Treatment1 Intervention

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

🇺🇸
Approved in United States as Transcranial Magnetic Stimulation for:
🇪🇺
Approved in European Union as Transcranial Magnetic Stimulation for:
🇨🇦
Approved in Canada as Transcranial Magnetic Stimulation for:

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+

Published Research Related to This Trial

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]

Citations

Repetitive transcranial magnetic stimulation for cerebellar ataxiarTMS can generate long-lasting effects in treating various complicated neurological diseases such as Parkinson's (50), Alzheimer's (51), and ataxia (52).
Effects of transcranial magnetic stimulation on cerebellar ...The effects of transcranial magnetic stimulation in improving cerebellar ataxia in the affected patients are significant.
The efficacy of repetitive transcranial magnetic stimulationThe rTMS is a safe, noninvasive technique for brain stimulation that has attracted growing interest as a treatment for ataxia due to its capacity to promote ...
4.movementdisorders.onlinelibrary.wiley.commovementdisorders.onlinelibrary.wiley.com/doi/10.1002/mdc3.14205
Effects of Non‐Invasive Brain Stimulation for Degenerative ...Non-invasive brain stimulation may reduce ataxia in DCA patients, but the estimated effect size may change in future studies.
Repetitive transcranial magnetic stimulation of the ...Previous research has demonstrated temporary functional improvement after sessions of high frequency cerebellar rTMS in patients with ataxia [22 ...
Effects of cerebellar repetitive transcranial magnetic ...Additionally, a study involving six stroke patients treated with ipsilateral cerebellar iTBS found improvements in ataxia symptoms (Bonnì et al.
Effects of cerebellar repetitive transcranial magnetic ...In this randomized sham controlled trial, 5 days of cerebellar transcranial magnetic stimulation plus physiotherapy improved ataxia severity.
Effects of transcranial magnetic stimulation on cerebellar ...The effects of transcranial magnetic stimulation in improving cerebellar ataxia in the affected patients are significant.
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