What side effects are associated with this type of intervention?

Non-invasive brain stimulation treatments like transcranial magnetic stimulation (TMS) for cerebellar ataxia are generally well-tolerated but can have some side effects. Common side effects include mild headaches, scalp discomfort at the stimulation site, tingling, and lightheadedness. Rarely, TMS can cause more serious side effects such as seizures, particularly in individuals with a predisposition to epilepsy. Overall, these treatments are considered safe with a low incidence of severe adverse events.

What prior FDA approvals exist?

There are no specific FDA-approved treatments for Cerebellar Ataxia that involve non-invasive brain stimulation or modulation of primary motor cortex activity. However, treatments such as transcranial magnetic stimulation (TMS) have been explored in clinical trials for other neurological conditions, including migraine and schizophrenia, showing some efficacy in symptom management. These findings suggest potential future applications for Cerebellar Ataxia, but as of now, no such treatments have received FDA approval for this specific condition.

What other types of research exist?

Promising novel alternatives to non-invasive brain stimulation for Cerebellar Ataxia patients include: 1) Antisense oligonucleotide therapy, which has shown potential in neurodegenerative diseases like ALS. 2) Sodium phenylbutyrate/taurursodiol, which has demonstrated benefits in ALS patients. 3) Levosimendan, an oral medication that has been tested in ALS for improving muscle function. These treatments are in various stages of clinical trials and may offer new avenues for managing Cerebellar Ataxia.

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Non-invasive Brain Stimulation

TMS for Cerebellar Ataxia

N/A

Waitlist Available

Led By Amanda S Therrien, PhD

Research Sponsored by Albert Einstein Healthcare Network

Eligibility Criteria Checklist

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

Must have

Meet safety criteria for receipt of transcranial magnetic stimulation

Normal or corrected-to-normal vision

Must not have

Extrapyramidal signs on neurologic examination

Cognitive or attention deficits that interfere with testing, the capacity to understand and follow task instructions, or the capacity to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

TMS may cause discomfort at the stimulation site, headache, lightheadedness, or seizures in very rare cases. Most side effects are mild and temporary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am cleared to receive brain stimulation treatment.

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My vision is normal or corrected to normal with glasses or contacts.

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My hearing is normal or corrected to normal.

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I have been diagnosed with cerebellar ataxia due to cerebellar degeneration.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have unusual movements or symptoms like Parkinson's.

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I can understand and follow instructions without any cognitive issues.

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I experience numbness or loss of sensation in my arms.

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I have an injury or pain in my arms.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Cortical Silent Period

International Cooperative Ataxia Rating Scale Limb Coordination Sub-Score

International Cooperative Ataxia Rating Scale Total Score

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcranial Magnetic Stimulation (TMS)

2018

Completed Phase 4

~550

0 / 8Eligibility criteria met

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

Non-invasive brain stimulation, such as transcranial magnetic stimulation (TMS), targets the primary motor cortex to modulate its activity. This technique uses magnetic fields to stimulate nerve cells in the brain, which can enhance motor learning and improve motor function. For patients with Cerebellar Ataxia, this is particularly important as the cerebellum plays a crucial role in coordinating movement and balance. By modulating the activity of the primary motor cortex, non-invasive brain stimulation can potentially compensate for the impaired cerebellar function, leading to better motor control and reduced ataxic symptoms.