36 Participants Needed

tDCS for Cognitive Impairment in Parkinson's Disease

(tDCS-PD-fMRI Trial)

JH
Overseen ByJi Hyun Ko, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment High-definition transcranial direct current stimulation (tDCS) for cognitive impairment in Parkinson's Disease?

Research shows that tDCS can improve certain cognitive functions in Parkinson's patients, like executive functions, which involve planning and decision-making. However, the effects on other cognitive areas like memory and attention are less clear, and more research is needed to confirm long-term benefits.12345

Is transcranial direct current stimulation (tDCS) safe for humans?

Research shows that tDCS is generally safe for humans, with no reports of serious or lasting side effects when used at standard levels (up to 4 milliamperes for 40 minutes). This includes studies involving over 33,200 sessions and 1,000 subjects, even among potentially vulnerable groups like the elderly and those with mood disorders.36789

How does high-definition transcranial direct current stimulation (tDCS) differ from other treatments for cognitive impairment in Parkinson's disease?

High-definition transcranial direct current stimulation (tDCS) is unique because it is a non-invasive brain stimulation technique that modulates brain activity to improve cognitive and motor functions in Parkinson's disease, unlike traditional drug therapies that primarily target symptoms through medication. It involves applying a mild electrical current to specific brain areas, which can enhance cognitive abilities and reduce movement-related symptoms without the side effects associated with medications.12345

What is the purpose of this trial?

Parkinson's disease (PD) has been classically regarded as a "movement disorder", so earlier work has focused on treating motor symptoms only. As PD patients now have longer life expectancy, the relatively slowly progressing cognitive deficits (compared to their motor deficits) have become one of the major challenges. Approximately 80% of PD patients eventually become demented. Therefore cognitive dysfunction is one of the most significant factors affecting the quality of life of patients with PD. While dementia in Parkinson's disease is routinely treated by cholinesterase inhibitors (e.g., donepezil and rivastigmine), their efficacy on mild cognitive impairment found in non-demented PD is questionable. Alternative approaches have been proposed including transcranial direct current stimulation (tDCS) but no consensus has been reached. This can be attributed mainly to: (1) imprecise knowledge of the underlying functional circuitry mediating this disease manifestation and (2) inter-individual variability. Here, the investigators will utilize a novel personalized network analysis approach to elucidate on the underlying mechanisms of the effect of tDCS on cognitive dysfunction in non-demented PD patients.It has been well documented that the caudate nucleus plays an important role in cognitive dysfunction found in PD. In the investigators' preliminary resting-state functional magnetic resonance imaging (fMRI) study, they have shown that the connectivity of the right caudate nucleus is correlated to cognitive status of PD patients measured by the Montreal Cognitive Assessment (MoCA). The investigators hypothesize that tDCS on the left and/or right dorsolateral prefrontal cortex may restore the functional connectivity of the right caudate nucleus which may in turn improve patients' cognitive performance.

Eligibility Criteria

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.
See 2 more

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.
See 7 more

Timeline

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

Treatment Details

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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

University of Manitoba

Lead Sponsor

Trials
628
Recruited
209,000+

Parkinson Society Canada

Collaborator

Trials
4
Recruited
160+

Findings from Research

Transcranial direct current stimulation (tDCS) shows potential in improving executive functions in Parkinson's disease patients, with a strong effect size (g = 1.51) reported in a meta-analysis of 8 studies involving 168 participants.
However, the study found no significant effects on other cognitive areas like attention, memory, and language, and it could not establish a clear cause-effect relationship between tDCS and cognitive improvements, indicating the need for further research and methodological enhancements.
Transcranial Direct Current Stimulation to Enhance Cognitive Impairment in Parkinson's Disease: A Systematic Review and Meta-Analysis.Suarez-García, DMA., Grisales-Cárdenas, JS., Zimerman, M., et al.[2020]
Transcranial direct current stimulation (tDCS) has shown significant improvements in motor function for patients with Parkinson's disease (PD), based on a systematic review of 10 studies conducted over the last decade.
While tDCS appears to enhance neurophysiological mechanisms in the PD brain, the exact physiological processes behind its long-term effects on cortical excitability remain unclear, indicating a need for further research.
Transcranial direct current stimulation in Parkinson's disease: Neurophysiological mechanisms and behavioral effects.Broeder, S., Nackaerts, E., Heremans, E., et al.[2019]
In a study involving nine patients with Parkinson's disease, five consecutive days of anodal transcranial direct current stimulation (tDCS) over the motor cortex and cerebellum significantly improved levodopa-induced dyskinesias, as measured by the UPDRS IV scale (p < 0.001).
While the study showed promising results for reducing dyskinesias, other motor and cognitive symptoms did not show significant changes with either tDCS or sham treatment, indicating that tDCS may specifically target dyskinesias in Parkinson's patients.
Cerebellar and Motor Cortical Transcranial Stimulation Decrease Levodopa-Induced Dyskinesias in Parkinson's Disease.Ferrucci, R., Cortese, F., Bianchi, M., et al.[2019]

References

Transcranial Direct Current Stimulation to Enhance Cognitive Impairment in Parkinson's Disease: A Systematic Review and Meta-Analysis. [2020]
Transcranial direct current stimulation in Parkinson's disease: Neurophysiological mechanisms and behavioral effects. [2019]
Cerebellar and Motor Cortical Transcranial Stimulation Decrease Levodopa-Induced Dyskinesias in Parkinson's Disease. [2019]
Transcranial Direct Current Stimulation (tDCS) as a Useful Rehabilitation Strategy to Improve Cognition in Patients With Alzheimer's Disease and Parkinson's Disease: An Updated Systematic Review of Randomized Controlled Trials. [2022]
Effects of transcranial direct current stimulation on working memory in patients with Parkinson's disease. [2022]
Changes of regional cerebral blood flow after repeated transcranial direct current stimulation in healthy participants: a pilot study. [2023]
Safety of Transcranial Direct Current Stimulation: Evidence Based Update 2016. [2022]
Safety of Transcranial Direct Current Stimulation in Neurorehabilitation. [2023]
A Systematic Review on the Acceptability and Tolerability of Transcranial Direct Current Stimulation Treatment in Neuropsychiatry Trials. [2018]
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