Recruiting

tDCS

Sponsor:

University of Manitoba

Code:

NCT03025334

Conditions

Parkinson Disease

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

Interventions

High-definition transcranial direct current stimulation

Study Details

Brief summary:

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.

Conditions

Parkinson Disease

Mild Cognitive Impairment

Study ID

NCT03025334

Start date

Mar 22, 2017

Status verified date

Apr, 2026

Completion date

Aug 31, 2027

Anticipated

Primary completion date

Aug 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40+

Healthy Volunteers: Not accepted

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 Design

Enrollment

36 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

sham comparator: Sham tDCS

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

active comparator: Real tDCS right

Real anodal tDCS (right DLPFC)

Interventions

High-definition transcranial direct current stimulation

brain stimulation to increase neuronal excitability in the targeted regions

Primary outcome measure

  • cognitive performance in neuropsychological tests [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

Ji Hyun Ko, PhD

204-318-2566ji.ko@umanitoba.ca

Locations

University of Manitoba

Recruiting

Winnipeg, Manitoba, Canada, R3E 0J9

Contacts

Ji Hyun Ko, PhD

204-318-2566ji.ko@umanitoba.ca

More Information

Sponsor

University of Manitoba

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Manitoba on 2026-05-01.