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Noninvasive Brain Stimulation

Transcranial Pulsed Current Stimulation for Ataxia (tPCS Trial)

N/A

Recruiting

Research Sponsored by Western University, Canada

Eligibility Criteria Checklist

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

Must have

Patients diagnosed with neurodegenerative ataxia (clinically or by genetic study)

Be older than 18 years old

Must not have

Patients with metal implants in the head/neck region

Patients unable to provide informed consent

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline - 2 weeks - 1 month - 3 months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a method that uses small electrical currents sent through scalp electrodes on patients with neurodegenerative ataxia. These patients have severe balance, speech, and coordination problems. The goal is to see if the electrical currents can improve their brain and nerve function.

Who is the study for?

This trial is for individuals diagnosed with neurodegenerative ataxia who can walk with support and communicate in English. It excludes pregnant women, those unable to consent, using illegal drugs, with pacemakers or metal implants in the head/neck area, and severe other illnesses.

What is being tested?

The study tests Transcranial Pulsed Current Stimulation (tPCS) on patients with ataxia. Participants will receive either real tPCS or a sham (fake) treatment daily for two weeks and be assessed over three months to see if it improves balance, coordination, speech, and motor function.

What are the potential side effects?

While not explicitly stated here, side effects of tPCS may include discomfort at the electrode sites on the scalp, headache, dizziness or nausea during stimulation. Long-term side effects are still being studied.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with neurodegenerative ataxia.

Exclusion Criteria

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

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I have metal implants in my head or neck.

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I am unable to understand and give consent for treatment.

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I cannot communicate in English.

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I cannot walk at all, even with help.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline - 2 weeks - 1 month - 3 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline - 2 weeks - 1 month - 3 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline - 2 weeks - 1 month - 3 months 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 the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline after 2-week/daily tPCS

Secondary study objectives

Change in speech

Change in the Cerebellar cognitive affective syndrome (CCAS) Scale From Baseline

Change in upper limb co-ordination

+1 more

Awards & Highlights

No Placebo-Only Group

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

Trial Design

2Treatment groups

Experimental Treatment

Group I: Sham tPCSExperimental Treatment1 Intervention

All patients will be randomized into daily cerebello- spinal tPCS or sham stimulation. Randomization will occur in a ratio of 1:1. Sham tPCS arm will receive active tPCS. Then they will be crossed over to Real tPCS arm.

Group II: Experimental: Real tPCSExperimental Treatment1 Intervention

All patients will be randomized into daily cerebello- spinal tPCS or sham stimulation. Randomization will occur in a ratio of 1:1. Real tPCS arm will receive active tPCS. Then they will be crossed over to Sham tPCS arm.

0 / 5Eligibility criteria met