NCT04787406

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Jan 2019

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2019

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2019

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
Last Updated

August 26, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

March 1, 2021

Last Update Submit

August 24, 2021

Conditions

Parkinson Disease

Keywords

Parkinson's diseaseTranscranial direct current stimulationMotor sequence learning

Outcome Measures

Primary Outcomes (3)

  • Change from baseline sequential finger tapping performance

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

    Two assessments: Baseline / pre-intervention, and immediately post-intervention

  • Change from baseline oxygenated haemoglobin response

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

    Two assessments: Baseline / pre-intervention, and immediately post-intervention

  • Change from baseline shape-counting error

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

    Two assessments: Baseline / pre-intervention, and immediately post-intervention

Study Arms (3)

Anodal tDCS

ACTIVE COMPARATOR

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

ACTIVE COMPARATOR

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 stimulationDEVICE

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.

Also known as: tDCS
Anodal tDCSCathodal tDCSSham tDCS

Eligibility Criteria

Age40 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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)

You may not qualify if:

  • History of stroke
  • Comorbidity
  • Cephalic implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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 DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsConvulsive TherapyPsychiatric Somatic TherapiesBehavioral Disciplines and ActivitiesElectroshockPsychological Techniques

Study Officials

  • Magaret Mak, Dr

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2021

First Posted

March 8, 2021

Study Start

January 7, 2019

Primary Completion

September 27, 2019

Study Completion

September 27, 2019

Last Updated

August 26, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)