tDCS on Parkinson's Disease Cognition (tDCS-PD-fMRI)
Primary Purpose
Parkinson Disease, Mild Cognitive Impairment
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High-definition transcranial direct current stimulation
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease
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.
Sites / Locations
- University of ManitobaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Sham Comparator
Active Comparator
Arm Label
Sham tDCS
Real tDCS right
Arm Description
sham tDCS (30sec ramp-up and 3sec ramp-down)
Real anodal tDCS (right DLPFC)
Outcomes
Primary Outcome Measures
cognitive performance in neuropsychological tests
Secondary Outcome Measures
Full Information
NCT ID
NCT03025334
First Posted
January 16, 2017
Last Updated
May 10, 2023
Sponsor
University of Manitoba
Collaborators
Parkinson Society Canada
1. Study Identification
Unique Protocol Identification Number
NCT03025334
Brief Title
tDCS on Parkinson's Disease Cognition
Acronym
tDCS-PD-fMRI
Official Title
Transcranial Direct Current Stimulation Treatment of Cognitive Dysfunction in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2017 (Actual)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba
Collaborators
Parkinson Society Canada
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Mild Cognitive Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
sham tDCS (30sec ramp-up and 3sec ramp-down)
Arm Title
Real tDCS right
Arm Type
Active Comparator
Arm Description
Real anodal tDCS (right DLPFC)
Intervention Type
Device
Intervention Name(s)
High-definition transcranial direct current stimulation
Intervention Description
brain stimulation to increase neuronal excitability in the targeted regions
Primary Outcome Measure Information:
Title
cognitive performance in neuropsychological tests
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ji Hyun Ko, PhD
Phone
204-318-2566
Email
ji.ko@umanitoba.ca
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0J9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Hyun Ko, PhD
Phone
204-318-2566
Email
ji.ko@umanitoba.ca
12. IPD Sharing Statement
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tDCS on Parkinson's Disease Cognition
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