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

NCT04811066 | Completed

• 1 other identifier: HSEARS20200203002
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; Transcranial direct current stimulation; Motor sequence learning

Outcome Measures

Primary Outcomes (2)

• Change from baseline: sequential finger tapping performance

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

  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.

• Change from baseline: shape-counting error

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

  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.

Secondary Outcomes (4)

• Change from baseline: oxygenated haemoglobin response

  Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention

• Change from baseline: Movement Disorders Society Unified Parkinson's Disease Rating Scale Motor Section (Part 3)

  Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention

• Change from baseline: upper limb motor task performance

  Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention

• Change from baseline: Purdue pegboard task performance

  Four assessments: Baseline / pre-intervention, three-days post intervention, 1 week post intervention, and 4 weeks post intervention

Study Arms (3)

Anodal tDCS

EXPERIMENTAL

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

Cathodal tDCS

EXPERIMENTAL

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

Sham tDCS

SHAM COMPARATOR

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

Interventions

Transcranial direct current stimulation DEVICE

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.

Also known as: tDCS

Anodal tDCS; Cathodal tDCS; Sham tDCS

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of stroke
• Comorbidity
• Cephalic implants

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hung Hom, Hong Kong

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Margaret Mak, Dr

  The Hong Kong Polytechnic University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2021
• First Posted: March 23, 2021
• Study Start: April 19, 2021
• Primary Completion: October 2, 2021
• Study Completion: October 2, 2021
• Last Updated: June 13, 2022

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)