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Noninvasive Brain Stimulation
Transcranial Pulsed Current Stimulation for Ataxia (tPCS Trial)
N/A
Waitlist Available
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 belowSelect...
I have been diagnosed with neurodegenerative ataxia.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have metal implants in my head or neck.
Select...
I am unable to understand and give consent for treatment.
Select...
I cannot communicate in English.
Select...
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
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 moreAwards & 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.
Find a Location
Who is running the clinical trial?
Western University, CanadaLead Sponsor
254 Previous Clinical Trials
59,271 Total Patients Enrolled
1 Trials studying Cerebellar Ataxia
15 Patients Enrolled for Cerebellar Ataxia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have metal implants in my head or neck.You have a pacemaker.My other health conditions do not affect my movement or brain wave tests.I am unable to understand and give consent for treatment.I cannot communicate in English.I have been diagnosed with neurodegenerative ataxia.You use drugs that are not allowed by law.I cannot walk at all, even with help.
Research Study Groups:
This trial has the following groups:- Group 1: Sham tPCS
- Group 2: Experimental: Real tPCS
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.