Motor Learning and tDCS in Parkinson's Disease

Sponsor
The Hong Kong Polytechnic University (Other)
Overall Status
Completed
CT.gov ID
NCT04787406
Collaborator
(none)
33
1
3
8.6
3.8

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transcranial direct current stimulation
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
33 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
The Effect of Single Session Transcranial Direct Current Stimulation on Sequential Motor Learning in Parkinson's Disease
Actual Study Start Date :
Jan 7, 2019
Actual Primary Completion Date :
Sep 27, 2019
Actual Study Completion Date :
Sep 27, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Anodal tDCS

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.

Device: Transcranial direct current stimulation
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.
Other Names:
  • tDCS
  • Active Comparator: Cathodal tDCS

    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.

    Device: Transcranial direct current stimulation
    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.
    Other Names:
  • tDCS
  • Sham Comparator: Sham tDCS

    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.

    Device: Transcranial direct current stimulation
    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.
    Other Names:
  • tDCS
  • Outcome Measures

    Primary Outcome Measures

    1. Change from baseline sequential finger tapping performance [Two assessments: Baseline / pre-intervention, and immediately post-intervention]

      A skill index reflecting the accuracy and speed of which participants perform a specified finger tapping sequence.

    2. Change from baseline oxygenated haemoglobin response [Two assessments: Baseline / pre-intervention, and immediately post-intervention]

      Task related changes of oxygenated haemoglobin as measured using functional near-infrared spectroscopy.

    3. Change from baseline shape-counting error [Two assessments: Baseline / pre-intervention, and immediately post-intervention]

      The percentage of shape counting error during dual task assessments. Sequential finger tapping + visual shape counting task.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Hong Kong Polytechnic University Hong Kong Hung Hom Hong Kong

    Sponsors and Collaborators

    • The Hong Kong Polytechnic University

    Investigators

    • Principal Investigator: Magaret Mak, Dr, The Hong Kong Polytechnic University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    The Hong Kong Polytechnic University
    ClinicalTrials.gov Identifier:
    NCT04787406
    Other Study ID Numbers:
    • HSEARS20181226002
    First Posted:
    Mar 8, 2021
    Last Update Posted:
    Aug 26, 2021
    Last Verified:
    Feb 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by The Hong Kong Polytechnic University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 26, 2021