tDCS on Parkinson's Disease Cognition

NCT ID: NCT03025334

Last Updated: 2023-12-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-22
• Study Completion Date: 2025-08-31

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Sham tDCS

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

Group Type: SHAM_COMPARATOR

High-definition transcranial direct current stimulation

Intervention Type: DEVICE

brain stimulation to increase neuronal excitability in the targeted regions

Real tDCS right

Real anodal tDCS (right DLPFC)

Group Type: ACTIVE_COMPARATOR

High-definition transcranial direct current stimulation

Intervention Type: DEVICE

brain stimulation to increase neuronal excitability in the targeted regions

Interventions

High-definition transcranial direct current stimulation

brain stimulation to increase neuronal excitability in the targeted regions

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Parkinson Society Canada

OTHER

Sponsor Role: collaborator

University of Manitoba

OTHER

Sponsor Role: lead

Responsible Party

Ji Hyun Ko, PhD

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University of Manitoba

Winnipeg, Manitoba, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Ji Hyun Ko, PhD

Role: CONTACT

Phone: 204-318-2566

Email: ji.ko@umanitoba.ca

Facility Contacts

Ji Hyun Ko, PhD

Role: primary

Other Identifiers

B2016:052

Identifier Type: -

Identifier Source: org_study_id