tDCS on Parkinson's Disease Cognition (tDCS-PD-fMRI)

November 29, 2023 updated by: Ji Hyun Ko, PhD, University of Manitoba

Transcranial Direct Current Stimulation Treatment of Cognitive Dysfunction in Parkinson's Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 0J9
        • Recruiting
        • University of Manitoba
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • Ability to provide written informed consent
  • defined by the Diagnostic and Statistical Manual of Mental Disorders; DSM-5)
  • Age > 40
  • fluent in English.
  • Patients' cognitive statuses will be evaluated by the participating neuropsychiatrist or a trained psychiatry or neurology resident.

Exclusion Criteria:

  • Patients with dementia (defined as a Montreal Cognitive Assessment score < 18)
  • Atypical parkinsonian features including myoclonus, apraxia, oculomotor abnormalities, ataxia, sensory loss, or pyramidal signs.
  • Abnormal MRI
  • metal implants or a cardiac pacemaker
  • Pregnant or breastfeeding women (female subjects of child bearing potential will be screened for pregnancy before MRI imaging).
  • severe dyskinesia that may interfere with the quality of the scan (e.g., dyskinesia involving head movement).
  • severe hypertension.
  • cardiovascular disease.
  • Patients with a history of seizure, stroke, moderate to severe head injury, high intracranial pressure, severe headaches, or presence of other neurologic disease that may be associated with an altered seizure threshold; or concurrent medication use, such as tricyclic antidepressants, neuroleptic medications, or other drugs that are known to lower seizure threshold
  • secondary conditions that may significantly alter electrolyte balance or lower seizure threshold.
  • Family history of epilepsy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Sham tDCS
sham tDCS (30sec ramp-up and 3sec ramp-down)
Device: High-definition transcranial direct current stimulation
brain stimulation to increase neuronal excitability in the targeted regions
Active Comparator: Real tDCS right
Real anodal tDCS (right DLPFC)
Device: High-definition transcranial direct current stimulation
brain stimulation to increase neuronal excitability in the targeted regions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
cognitive performance in neuropsychological tests
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Manitoba

Collaborators

Parkinson Society Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2017

Primary Completion (Estimated)

August 31, 2025

Study Completion (Estimated)

August 31, 2025

Study Registration Dates

First Submitted

January 16, 2017

First Submitted That Met QC Criteria

January 18, 2017

First Posted (Estimated)

January 19, 2017

Study Record Updates

Last Update Posted (Actual)

December 1, 2023

Last Update Submitted That Met QC Criteria

November 29, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B2016:052

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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