tDCS for Cognitive Impairment in Parkinson's Disease

(tDCS-PD-fMRI Trial)

Overseen By Ji Hyun Ko, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Manitoba

Must not be taking: Tricyclics, Neuroleptics, others

Disqualifiers: Dementia, Severe hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether high-definition transcranial direct current stimulation (tDCS) can improve memory and thinking skills in people with Parkinson's disease. While Parkinson's is mainly known for affecting movement, it can also lead to memory and thinking problems over time. The trial uses a special type of brain stimulation to determine its effectiveness. Individuals diagnosed with Parkinson's who struggle with cognitive issues, but have not yet developed full dementia, may be suitable candidates for this trial. As an unphased study, this trial provides a unique opportunity to contribute to groundbreaking research that could enhance cognitive health in Parkinson's patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are taking tricyclic antidepressants, neuroleptic medications, or other drugs that lower seizure threshold, you may not be eligible to participate.

What prior data suggests that this device is safe for cognitive impairment in Parkinson's disease?

Research has shown that high-definition transcranial direct current stimulation (tDCS) is generally safe and easy to manage. In various studies, most participants felt either nothing or only mild sensations during sessions, indicating that the treatment is comfortable for most. One study found that tDCS does not cause significant side effects, as participants did not experience major changes in thinking or memory, meaning the treatment did not harm brain function. While tDCS is painless and non-invasive, individuals should consider personal reactions and consult healthcare professionals before joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for cognitive impairment in Parkinson's disease, which often involve medications like levodopa or dopamine agonists, high-definition transcranial direct current stimulation (tDCS) offers a non-invasive brain stimulation method. Researchers are excited about tDCS because it directly targets the right dorsolateral prefrontal cortex (DLPFC) to potentially enhance cognitive function without the side effects associated with drugs. Additionally, this approach is unique as it uses electrical currents to modulate brain activity, which could provide a more targeted and immediate impact on cognitive symptoms.

What evidence suggests that tDCS is effective for cognitive impairment in Parkinson's disease?

Research has shown that transcranial direct current stimulation (tDCS) might improve thinking skills in people with Parkinson's disease. Studies have found that tDCS can enhance overall brain function, particularly in decision-making and language areas. Early findings suggest that applying tDCS to specific brain regions might help rebuild crucial connections for thinking and memory. This trial will compare real tDCS, applied to the right DLPFC, with a sham tDCS procedure. This approach could be especially beneficial for those with mild memory problems in Parkinson's, where regular medications often prove ineffective. Although researchers continue to study this method, early results are promising for enhancing brain function without drugs. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My mental health will be checked by a specialist.

Fluent in English

I have been diagnosed with Parkinson's disease based on having at least two main symptoms.

Exclusion Criteria

I experience unusual movement or sensory symptoms not typical for Parkinson's disease.

I am not pregnant or breastfeeding.

You have other health conditions that can change the balance of minerals in your body or make you more likely to have seizures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial direct current stimulation (tDCS) on the left and/or right dorsolateral prefrontal cortex to improve cognitive performance

6 weeks

Weekly visits for tDCS sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High-definition transcranial direct current stimulation

Trial Overview 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.

How Is the Trial Designed?

Group I: Real tDCS right Active Control 1 Intervention

Real anodal tDCS (right DLPFC)

Group II: Sham tDCS Placebo Group 1 Intervention

sham tDCS (30sec ramp-up and 3sec ramp-down)

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials

628

Recruited

209,000+

Parkinson Society Canada

Collaborator

Trials

4

Recruited

160+

Citations

1. nature.com nature.com/articles/s41531-024-00821-z

Transcranial direct current stimulation for Parkinson's disease It appears, thus, that tDCS may exert beneficial effects on cognitive functioning in patients with PD while having no or only minor effects on ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11880240/

Efficacy of transcranial direct current stimulation on ... tDCS demonstrated substantial efficacy in enhancing overall cognition in patients with PD. The efficacy of tDCS was obvious in executive function, language, ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12491758/

Transcranial Direct Current Stimulation in Parkinson's Disease ... tDCS has demonstrated hypoalgesic effects on Parkinson's disease (PD)‐related pain applied in the On state but not in the Off state.

4. sciencedirect.com sciencedirect.com/science/article/pii/S2274580724006150

High definition transcranial direct current stimulation as an ... Cognitive outcomes were measured at baseline, after the last HD-tDCS session, and 8-weeks post-treatment. The primary outcome was change in total learning and ...

5. thejcn.com thejcn.com/DOIx.php?id=10.3988/jcn.2022.18.4.391

Potential of Transcranial Direct Current Stimulation in ... We provide a brief overview of the current development and application status of tDCS as a nonpharmacological therapeutic method for AD and mild cognitive ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11040101/

Safety and feasibility of optimized transcranial direct ... This study aims to determine the feasibility and safety of applying tDCS treatment using optimized and personalized tDCS electrode positions in patients with ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6742726/

A Randomized Sham-Controlled Pilot Study These findings suggest that tDCS is safe and tolerable but causes no statistically significant cognitive effects in patients with mild or major ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1935861X23019010

Tolerability and blinding of high-definition transcranial ... HD-tDCS was well tolerated with mostly no (“none”) or “mild” sensations reported across sessions, regardless of active or sham condition and in both stimulation ...

9. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2025.1495492/full

Efficacy of transcranial direct current stimulation on ... tDCS demonstrated substantial efficacy in enhancing overall cognition in patients with PD. The efficacy of tDCS was obvious in executive function, language, ...

10. sciencedirect.com sciencedirect.com/science/article/pii/S0188440924001383

Transcranial Direct Current Stimulation for Cognitive ... Recently, transcranial direct current stimulation (tDCS) has emerged as a safe, painless, and non-invasive brain stimulation technique capable of selectively ...