NCT06818240

Brief Summary

Stroke often impairs lower limb control, resulting in gait abnormalities and difficulties in dual-task performance, such as walking while engaging in cognitive activities. This study examines the effects of a single session of transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex (DLPFC) on dual-task walking performance in individuals with chronic stroke. Using a cross-over design, participants will undergo two sessions (active or sham tDCS, 7 ± 2 days apart) of stimulation at 2 mA for 30 minutes. Walking performance will be measured using single and dual-task conditions combining motor (e.g., 20 m walk) and cognitive tasks (e.g., word association, random number recall). Primary outcomes include walking speed (m/s), stride length (m), and dual-task cost (DTC) for mobility and cognitive speed. The study aims to evaluate tDCS as a potential tool to reduce DTC, improve dual-task performance, and improve daily function and quality of life in stroke survivors. Results may guide the development of tailored dual-task interventions in stroke rehabilitation.

Trial Health

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Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 10, 2025

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2025

Completed
Last Updated

February 10, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

January 23, 2025

Last Update Submit

February 4, 2025

Conditions

Keywords

transcranial direct current stimulationstrokedual task

Outcome Measures

Primary Outcomes (5)

  • Gait speed

    Kinematic data will be collected using a motion tracking system, the MobilityLab system (APDM Inc., Portland, OR, USA), and the Opal IMU sensor module (with 128 Hz sampling frequency). A total of eight sensors will be attached with Velcro straps to the sternum of the upper body, the lumbar region, and pairs of thighs, lower legs, and feet. The walking speed (m/s) will be recorded during each walking task.

    Immediately after the active/sham tDCS intervention

  • Stride length

    Kinematic data will be collected using a motion tracking system, the MobilityLab system (APDM Inc., Portland, OR, USA), and the Opal IMU sensor module (with 128 Hz sampling frequency). A total of eight sensors will be affixed using velcro belts, positioned on the sternum of the upper body, at the lumbar region, and on pairs of upper legs, lower legs, and feet. Stride length (m) will be recorded during each walking task.

    Immediately after the active/sham tDCS intervention

  • Cognitive response rate

    Cognitive performance will be evaluated during each task by the number of correct words per second, defined as the response rate (correct responses/second).

    Immediately after the active/sham tDCS intervention

  • DTC- Mobility speed

    The impact of dual-tasking will be quantified by calculating the dual-task cost (DTC) using the following formula: DTC (%) = (dual task outcome measure-single task outcome measure)/single task outcome measure × 100. DTC-mobility speed indicates the variation in speed used under dual-task versus single-task conditions.

    Immediately after the active/sham tDCS intervention

  • DTC- Cognitive speed

    The impact of dual-tasking will be quantified by calculating the dual-task cost (DTC) using the following formula: DTC (%) = (dual task outcome measure-single task outcome measure)/single task outcome measure × 100. For example, DTC-time reflects the variation in time taken to complete the SWR test under dual-task versus single-task conditions. DTC- Cognitive speed represents the variation in response rate under both conditions.

    Immediately after the active/sham tDCS intervention

Study Arms (2)

A constant current of 2 mA was applied for 30 minutes

ACTIVE COMPARATOR

In the active tDCS session, a constant current of 2 mA was applied for 30 minutes, with a 30-second ramp-up and ramp-down for comfort.

Device: Active transcranial direct current stimulation

no active current was applied throughout the stimulation phase

SHAM COMPARATOR

For the sham condition, no active current was applied throughout the stimulation phase, except for an electrical current of 1 mA, which was delivered for the first and last 60 seconds, with similar ramping to control for potential sensation bias.

Device: Sham transcranial direct current stimulation

Interventions

In the active tDCS session, real stimulation was delivered via a current stimulator (DC-STIMULATOR MC, NeuroConn, Germany) using saline-soaked 4×6 cm² electrodes. The anode was positioned over the left-DLPFC identified as F3 according to the 10-20 international EEG system, and the cathode over the right supraorbital ridge.

A constant current of 2 mA was applied for 30 minutes

In the Sham tDCS session, Sham stimulation was delivered via a current stimulator (DC-STIMULATOR MC, NeuroConn, Germany) using saline-soaked 4×6 cm² electrodes. The anode was positioned over the left-DLPFC identified as F3 according to the 10-20 international EEG system, and the cathode over the right supraorbital ridge.

no active current was applied throughout the stimulation phase

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age between 50 and 80 years
  • at least 6 months post-first-ever stroke with unilateral motor deficits
  • ability to walk independently for at least 10 m without the use of walking aids
  • a score of 24 or higher on the Mini-Mental State Examination (MMSE)

You may not qualify if:

  • unstable medical conditions, such as heart failure, uncontrolled hypertension, or cancer
  • presence of other comorbidities that could interfere with gait
  • history of contraindications to tDCS, such as epilepsy or metal implants
  • history of head injury, head surgery, or lower limb orthopedic issues

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, China, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Shamay SM NG, PhD

    The Hong Kong Polytechnic University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shamay SM NG, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof.

Study Record Dates

First Submitted

January 23, 2025

First Posted

February 10, 2025

Study Start

November 1, 2024

Primary Completion

February 28, 2025

Study Completion

February 28, 2025

Last Updated

February 10, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations