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Motor Learning and tDCS in Parkinson's Disease

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
The Hong Kong Polytechnic University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, Transcranial direct current stimulation, Motor sequence learning

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Right-handed (Edinburgh Handedness Inventory; ≥50)
  • Cognitively capable (Montreal Cognitive Assessment (MoCA); ≥23)
  • Mild to moderate Parkinson's disease severity (Hoehn and Yar disease stage 2-3)

Exclusion Criteria:

  • History of stroke
  • Comorbidity
  • Cephalic implants

Sites / Locations

  • The Hong Kong Polytechnic University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Anodal tDCS

Cathodal tDCS

Sham tDCS

Arm Description

Anodal electrode (35 cm2 sponge electrode) placed over C3. Cathodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area. 20 minutes of stimulation at 2 mA with a 30-second phase-in and phase-out period.

Cathodal electrode (35 cm2 sponge electrode) placed over C3. Anodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area. 20 minutes of stimulation at 2 mA with a 30-second phase-in and phase-out period.

Anodal electrode (35 cm2 sponge electrode) placed over C3. Cathodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area. Stimulation was phased in for 30 seconds up to 2 mA and then switched off. Stimulation was again phased in for 30 seconds following 20 minutes of no stimulation.

Outcomes

Primary Outcome Measures

Change from baseline sequential finger tapping performance
A skill index reflecting the accuracy and speed of which participants perform a specified finger tapping sequence.
Change from baseline oxygenated haemoglobin response
Task related changes of oxygenated haemoglobin as measured using functional near-infrared spectroscopy.
Change from baseline shape-counting error
The percentage of shape counting error during dual task assessments. Sequential finger tapping + visual shape counting task.

Secondary Outcome Measures

Full Information

First Posted
March 1, 2021
Last Updated
August 24, 2021
Sponsor
The Hong Kong Polytechnic University
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1. Study Identification

Unique Protocol Identification Number
NCT04787406
Brief Title
Motor Learning and tDCS in Parkinson's Disease
Official Title
The Effect of Single Session Transcranial Direct Current Stimulation on Sequential Motor Learning in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
January 7, 2019 (Actual)
Primary Completion Date
September 27, 2019 (Actual)
Study Completion Date
September 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Hong Kong Polytechnic University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The present study sought to examine the efficacy of single session transcranial direct current stimulation applied over the primary motor cortex in people with Parkinson's disease on sequential motor learning performance.
Detailed Description
Parkinson's disease is characterised by deficits of motor control triggered by impaired basal ganglia function, such as bradykinesia and tremor. Beyond the visibly recognisable motor symptoms of Parkinson's disease, the ability to learn a sequence of movements is also compromised and poses a significant barrier to effective rehabilitation. In healthy individuals, transcranial direct current stimulation applied over the primary motor cortex during motor task practice has been shown to significantly improve motor learning compared to placebo conditions. The present study sought to examine the effect of a single session of transcranial direct current stimulation applied over the primary motor cortex in people with Parkinson's disease on sequential motor learning performance. Participants learnt two finger tapping sequences, with task difficulty indexed by sequence length, and task consolidation further examined using a dual-task paradigm. Task related cortical haemodynamic activity was recorded using functional near-infrared spectroscopy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, Transcranial direct current stimulation, Motor sequence learning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anodal tDCS
Arm Type
Active Comparator
Arm Description
Anodal electrode (35 cm2 sponge electrode) placed over C3. Cathodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area. 20 minutes of stimulation at 2 mA with a 30-second phase-in and phase-out period.
Arm Title
Cathodal tDCS
Arm Type
Active Comparator
Arm Description
Cathodal electrode (35 cm2 sponge electrode) placed over C3. Anodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area. 20 minutes of stimulation at 2 mA with a 30-second phase-in and phase-out period.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Anodal electrode (35 cm2 sponge electrode) placed over C3. Cathodal electrode (35 cm2 sponge electrode) placed over the right supraorbital area. Stimulation was phased in for 30 seconds up to 2 mA and then switched off. Stimulation was again phased in for 30 seconds following 20 minutes of no stimulation.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation
Other Intervention Name(s)
tDCS
Intervention Description
Transcranial electrical stimulation device. A weak direct electrical current, up to 2 mA, is passed between two electrodes placed on the scalp. Electrodes are housed in 35 cm2 sponges saturated with 4 ml of saline solution (0.9 % NaCl) per side, per pad. Stimulation is phased in with a 30 second ramp up period prior to the specified stimulation period and phased-out with a ramp down of the current following the specified stimulation period. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off for during the specified stimulation period.
Primary Outcome Measure Information:
Title
Change from baseline sequential finger tapping performance
Description
A skill index reflecting the accuracy and speed of which participants perform a specified finger tapping sequence.
Time Frame
Two assessments: Baseline / pre-intervention, and immediately post-intervention
Title
Change from baseline oxygenated haemoglobin response
Description
Task related changes of oxygenated haemoglobin as measured using functional near-infrared spectroscopy.
Time Frame
Two assessments: Baseline / pre-intervention, and immediately post-intervention
Title
Change from baseline shape-counting error
Description
The percentage of shape counting error during dual task assessments. Sequential finger tapping + visual shape counting task.
Time Frame
Two assessments: Baseline / pre-intervention, and immediately post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Right-handed (Edinburgh Handedness Inventory; ≥50) Cognitively capable (Montreal Cognitive Assessment (MoCA); ≥23) Mild to moderate Parkinson's disease severity (Hoehn and Yar disease stage 2-3) Exclusion Criteria: History of stroke Comorbidity Cephalic implants
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magaret Mak, Dr
Organizational Affiliation
The Hong Kong Polytechnic University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hong Kong Polytechnic University
City
Hong Kong
State/Province
Hung Hom
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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Motor Learning and tDCS in Parkinson's Disease

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