TMS for Cerebellar Ataxia

Overseen By Grace Loscalzo

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Albert Einstein Healthcare Network

Disqualifiers: Extrapyramidal signs, Drug abuse, Cognitive deficits, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

12 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

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

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. ^{1 2 3 4 5}

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. ^{2 3 5 6 7}

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. ^{2 3 5 8 9}

Who Is on the Research Team?

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.

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.

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?

Group I: rTMS Intervention Experimental Treatment 1 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)

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of transcranial magnetic stimulation in Parkinson's disease: a review of the literature. Vonloh, M., Chen, R., Kluger, B.[2021]

Citations

1. Denmark pubmed.ncbi.nlm.nih.gov

Reduced intracortical facilitation in patients with cerebellar degeneration. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Repetitive Transcranial Magnetic Stimulation in Cerebellar Ataxia: a Systematic Review and Meta-analysis. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Cerebellar TMS in treatment of a patient with cerebellar ataxia: evidence from clinical, biomechanics and neurophysiological assessments. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Repetitive Transcranial Magnetic Stimulation in Spinocerebellar Ataxia: A Pilot Randomized Controlled Trial. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Effectiveness of High-Frequency Repetitive Transcranial Magnetic Stimulation in Patients With Spinocerebellar Ataxia Type 3. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Safety of transcranial magnetic stimulation in Parkinson's disease: a review of the literature. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

The Effect of Cerebellar rTMS on Modulating Motor Dysfunction in Neurological Disorders: a Systematic Review. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Bilateral Cerebellar Repetitive Transcranial Magnetic Stimulation for Chronic Ataxia After Hemorrhagic Stroke: a Case Report. [2023]

9. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Noninvasive Cerebellar Stimulation as a Complement Tool to Pharmacotherapy. [2020]