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Motor Learning and Multi-session tDCS in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT04811066
Recruitment Status : Recruiting
First Posted : March 23, 2021
Last Update Posted : March 23, 2021
Sponsor:
Information provided by (Responsible Party):
The Hong Kong Polytechnic University

Brief Summary:
The present study seeks to examine the efficacy of multi-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
Parkinson Disease Device: Transcranial direct current stimulation Not Applicable

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 seeks to examine the effect of multi-session transcranial direct current stimulation applied over the primary motor cortex in people with Parkinson's disease on sequential motor learning performance. Participants will be required to attend eight laboratory sessions, comprising five intervention and three assessment sessions and will be tested on their ability to learn a 16-digit finger tapping sequence with their right hand. Sessions one to five will form the intervention and will be performed at the same time on consecutive days (i.e. mon-fri). In addition, session one will double as a baseline assessment and intervention session. Assessments sessions will be performed once before the intervention (session one), and three times following the intervention on day three, one week, and four weeks post intervention.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effect of Multi-session Transcranial Direct Current Stimulation Applied Over the Primary Motor Cortex on Motor Sequence Learning in Parkinson's Disease
Estimated Study Start Date : April 5, 2021
Estimated Primary Completion Date : September 29, 2021
Estimated Study Completion Date : September 29, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 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 of the electrical current to the specified stimulation parameters. Following the specified stimulation period, the current is phased-out with a ramp down of the current. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off during the specified stimulation period.

Other Name: tDCS

Experimental: 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 of the electrical current to the specified stimulation parameters. Following the specified stimulation period, the current is phased-out with a ramp down of the current. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off during the specified stimulation period.

Other Name: 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 of the electrical current to the specified stimulation parameters. Following the specified stimulation period, the current is phased-out with a ramp down of the current. For sham stimulation, the ramp-up and ramp-down periods are retained, but stimulation is switched off during the specified stimulation period.

Other Name: tDCS




Primary Outcome Measures :
  1. Change from baseline: sequential finger tapping performance [ Time Frame: Four assessments: Baseline (pre-intervention), 3 days, 1 week, and 4 weeks post intervention. Performance is also assessed during the intervention period on each day the intervention is applied. Once immediately before and after intervention is applied. ]
    A skill index reflecting the accuracy and speed that participants perform a specified finger tapping sequence.

  2. Change from baseline: shape-counting error [ Time Frame: Four assessments: Baseline (pre-intervention), 3 days, 1 week, and 4 weeks post intervention. Performance is also assessed during the intervention period on each day the intervention is applied. Once immediately before and after intervention is applied. ]
    The percentage of shape counting error during dual task assessments. Sequential finger tapping + visual shape counting task.


Secondary Outcome Measures :
  1. Change from baseline: oxygenated haemoglobin response [ Time Frame: Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention ]
    Task related changes of oxygenated haemoglobin as measured using functional near-infrared spectroscopy.

  2. Change from baseline: Movement Disorders Society Unified Parkinson's Disease Rating Scale Motor Section (Part 3) [ Time Frame: Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention ]
    Participants physical function is assessed according to the criteria of the Movement Disorders Society Unified Parkinson's Disease Rating Scale Motor Section (Part 3).

  3. Change from baseline: upper limb motor task performance [ Time Frame: Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention ]
    Timed sequential movement of the arm and hand. The participant sits upright on a chair that has no arm support with their arms relaxed by their side. The time taken to perform the following sequence 10 times is recorded: 1. Close and open hand, 2) flex elbow, 3) close and open hand, 4) extend elbow. Right and left arms are assessed separately.

  4. Change from baseline: Purdue pegboard task performance [ Time Frame: Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention ]
    Participants are required to pick up a metal peg and place the peg in a specified row of holes. Pegs must be placed one at a time. The maximum number of pegs placed within 30 seconds is recorded. The assessment is repeated three times for each hand. Each hand is assessed separately.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
  • On stable dopaminergic medication

Exclusion Criteria:

  • History of stroke
  • Comorbidity
  • Cephalic implants

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04811066


Contacts
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Contact: Michael Simpson 2766 6693 ext +852 michael.simpson@connect.polyu.hk
Contact: Michael Simpson 9177 6051 ext +852 michael.simpson@connect.polyu.hk

Locations
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Hong Kong
The Hong Kong Polytechnic University Recruiting
Hong Kong, Hung Hom, Hong Kong
Contact: Michael Simpson    2766 6693    michael.simpson@connect.polyu.hk   
Sponsors and Collaborators
The Hong Kong Polytechnic University
Investigators
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Principal Investigator: Margaret Mak, Dr The Hong Kong Polytechnic University
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Responsible Party: The Hong Kong Polytechnic University
ClinicalTrials.gov Identifier: NCT04811066    
Other Study ID Numbers: HSEARS20200203002
First Posted: March 23, 2021    Key Record Dates
Last Update Posted: March 23, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
Parkinson's disease
Transcranial direct current stimulation
Motor sequence learning
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases