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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline - 2 weeks - 1 month - 3 months
Awards & highlights

tPCS Trial Summary

This trial will study the effect of non-invasive brain stimulation on patients with neurodegenerative ataxia, to improve their balance, speech and hand coordination.

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.Check my eligibility
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.See study design
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.

tPCS Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with neurodegenerative ataxia.

tPCS Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in the Scale for the Assessment and Rating of Ataxia (SARA) Score From Baseline after 2-week/daily tPCS
Secondary outcome measures
Change in speech
Change in the Cerebellar cognitive affective syndrome (CCAS) Scale From Baseline
Change in upper limb co-ordination
+1 more

tPCS 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
239 Previous Clinical Trials
57,468 Total Patients Enrolled
1 Trials studying Cerebellar Ataxia
15 Patients Enrolled for Cerebellar Ataxia

Media Library

Cerebellar-spinal Transcranial Pulsed Current Stimulation (tPCS) (Noninvasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT05625620 — N/A
Cerebellar Ataxia Research Study Groups: Experimental: Real tPCS, Sham tPCS
Cerebellar Ataxia Clinical Trial 2023: Cerebellar-spinal Transcranial Pulsed Current Stimulation (tPCS) Highlights & Side Effects. Trial Name: NCT05625620 — N/A
Cerebellar-spinal Transcranial Pulsed Current Stimulation (tPCS) (Noninvasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05625620 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is permitted to enroll in this experiment?

"Fifteen individuals with hypermetria, between the age of 18 and 70 will be recruited for this project. The primary prerequisites are as follows: Diagnosed cases of neurodegenerative ataxia (diagnosis confirmed through clinical or genetic research)."

Answered by AI

Is enrollment for this research endeavor currently available?

"Affirmative. The clinicaltrials.gov website confirms that this investigation is in the midst of patient recruitment, with an initial posting date on January 1st 2023 and a most recent update from November 14th 2022. Altogether, 15 people need to be recruited across 1 site for successful trial completion."

Answered by AI

To what extent is this research project engaged with participants?

"Indeed, the information on clinicaltrials.gov affirms that this experiment is actively recruiting patients; it was initially posted in January 1st 2023 and last modified on November 14th 2022. The study requires 15 individuals to participate at a single location."

Answered by AI

Are individuals aged fifty and above being invited to participate in this trial?

"Patients that meet the requirements for this clinical trial must be aged between 18 and 70. Should a younger or older individual desire to participate in a medical study, there are 18 trials available for minors and 33 specifically catered towards seniors."

Answered by AI

Who else is applying?

What site did they apply to?
London Health Sciences Centre
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What state do they live in?
New York
~2 spots leftby Jun 2024