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Non-invasive Brain Stimulation

tDCS for Cognitive Impairment in Parkinson's Disease (tDCS-PD-fMRI Trial)

N/A
Recruiting
Research Sponsored by University of Manitoba
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients must meet diagnostic criteria for idiopathic Parkinson's disease, defined as the presence of two or more of the cardinal clinical features of PD in the absence of known causes of parkinsonism such as encephalitis or neuroleptic treatment
Age > 40
Must not have
Atypical parkinsonian features including myoclonus, apraxia, oculomotor abnormalities, ataxia, sensory loss, or pyramidal signs
Pregnant or breastfeeding women (female subjects of child bearing potential will be screened for pregnancy before MRI imaging)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years

Summary

This trial aims to use a novel personalized network analysis approach to elucidate the mechanisms of the effect of tDCS on cognitive dysfunction in non-demented PD patients.

Who is the study for?
This trial is for English-speaking adults over 40 with Parkinson's Disease who can consent and have at least two classic symptoms without other known causes. They should not be demented, as determined by a specific cognitive test, and must not have severe movement issues that could affect scans.
What is being tested?
The study tests if high-definition transcranial direct current stimulation (tDCS) on the prefrontal cortex can improve cognitive function in non-demented Parkinson's patients by affecting brain connectivity.
What are the potential side effects?
Potential side effects of tDCS may include discomfort at the electrode site, itching or tingling during stimulation, headache, fatigue, nausea or insomnia. Serious risks are rare but may include seizures.

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 Parkinson's disease based on having at least two main symptoms.
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I am over 40 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I experience unusual movement or sensory symptoms not typical for Parkinson's disease.
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I am not pregnant or breastfeeding.
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My family has a history of epilepsy.
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I have a history of severe neurological issues or take medication that lowers seizure threshold.
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I have very high blood pressure.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Real tDCS rightActive Control1 Intervention
Real anodal tDCS (right DLPFC)
Group II: Sham tDCSPlacebo Group1 Intervention
sham tDCS (30sec ramp-up and 3sec ramp-down)

Find a Location

Who is running the clinical trial?

Parkinson Society CanadaOTHER
3 Previous Clinical Trials
119 Total Patients Enrolled
University of ManitobaLead Sponsor
621 Previous Clinical Trials
206,527 Total Patients Enrolled

Media Library

High-definition transcranial direct current stimulation (Non-invasive Brain Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03025334 — N/A
Parkinson's Disease Research Study Groups: Sham tDCS, Real tDCS right
Parkinson's Disease Clinical Trial 2023: High-definition transcranial direct current stimulation Highlights & Side Effects. Trial Name: NCT03025334 — N/A
High-definition transcranial direct current stimulation (Non-invasive Brain Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03025334 — N/A
~3 spots leftby Aug 2025
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