Effects of rTMS Combined With Dual-Task Gait Training on Walking and Cognition After Stroke

NCT07356687 | Recruiting

• 1 other identifier: HSEARS20250731004
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized, double-blind, placebo-controlled trial will investigate whether repetitive transcranial magnetic stimulation (rTMS) applied to the dorsolateral prefrontal cortex (DLPFC) can enhance the effects of dual-task gait training in people with chronic stroke. Participants will be randomly allocated to receive either active rTMS or sham rTMS immediately before the same standardized dual-task gait training program. The intervention includes 12 sessions over 3 weeks. Outcomes will be assessed at baseline, immediately after training, and at 4-week follow-up. Co-primary outcomes are dual-task mobility and cognitive performance during walking, quantified using dual-task cost (DTC) for gait speed and cognitive-task performance during dual-task walking (e.g., Serial 7s; Shopping List Recall). Secondary outcomes include balance/mobility, community participation, mood/sleep measures, and fall incidence. To explore mechanisms, prefrontal cortex activity during single- and dual-task walking will be recorded using functional near-infrared spectroscopy (fNIRS), and mediation analyses will examine whether changes in PFC activity explain intervention effects.

Conditions

Stroke

Keywords

Dual-task training; rTMS; Post-stroke rehabilitation; Cognitive-motor interference

Outcome Measures

Primary Outcomes (2)

• Dual-task cost (DTC) of walking speed (%)

  Walking speed (m/s) measured during single-task walking and dual-task walking (walking + Serial 7s; walking + Shopping List Recall). DTC computed as (single-task - dual-task) / single-task × 100%; higher DTC indicates greater cognitive-motor interference. Speed will be averaged across three 45-s trials per condition.

  Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)

• Dual-task cost (DTC) of cognitive performance (%)

  Cognitive performance recorded as number of correct responses during dual-task walking conditions: Serial 7s: number of correct subtractions during the 45-s trial Shopping List Recall: number of items correctly recalled immediately after the 45-s sitting/walking trial. DTC computed as (single-task - dual-task) / single-task × 100%; higher DTC indicates worse cognitive-motor interference. Values averaged across three trials per condition.

  Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)

Secondary Outcomes (13)

• Timed Up and Go (TUG) time (seconds)

  Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)

• Mini-BESTest total score

  Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)

• Activities-specific Balance Confidence Scale (ABC) score

  Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)

• Fall incidence (number of falls)

  During 6 months post-intervention follow-up

• Stride length (cm)

  Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)

Other Outcomes (4)

• Prefrontal cortex hemodynamic response (fNIRS HbO) during walking

  Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)

• Depression Anxiety Stress Scales-21 (DASS-21) subscale scores

  Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)

• Pittsburgh Sleep Quality Index (PSQI) global score

  Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)

Study Arms (2)

active rTMS with dual-task training

EXPERIMENTAL

Participants will receive rTMS targeting the DLPFC of the affected hemisphere immediately before each session of standardized dual-task gait training (12 sessions over 3 weeks)

Other: active rTMS with dual-task training

sham rTMS with dual-task training

ACTIVE COMPARATOR

Participants will receive sham rTMS (placebo stimulation) targeting the same DLPFC location immediately before each session of the same standardized dual-task gait training (12 sessions over 3 weeks).

Other: sham rTMS with dual-task training

Interventions

active rTMS with dual-task training OTHER

Participants will receive active rTMS targeting the DLPFC of the affected hemisphere before each training session: 5 Hz, 90% resting motor threshold (RMT), 10-second trains with 30-second inter-train intervals, total 1,200 pulses (≈ 16 minutes) per session. Dual-task gait training will start within \~10 minutes after rTMS. The program includes 12 sessions over 3 weeks.

active rTMS with dual-task training

sham rTMS with dual-task training OTHER

Participants will receive sham rTMS delivered using the placebo side of the same coil at the same DLPFC target location and with identical session duration and procedures (≈ 16 minutes) before each training session. Dual-task gait training will start within \~10 minutes after sham stimulation. The program includes 12 sessions over 3 weeks.

sham rTMS with dual-task training

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Unilateral ischemic or hemorrhagic hemispheric stroke
• Age ≥ 50 years
• ≥ 6 months post-stroke
• Medically stable
• Able to walk independently ≥ 1 minute (assistive device allowed)
• Able to follow commands
• mRS 1-3
• MoCA ≥ 22

You may not qualify if:

• Other neurological disorders
• Cerebellar/brainstem injury
• TMS contraindications (e.g., pacemaker, intracranial metal, seizure history, pregnancy)
• Contraindications to exercise (e.g., unstable angina)
• Severe aphasia (NIHSS item 9 ≥ 2)
• Pain/illness limiting performance
• Concurrent formal rehabilitation elsewhere
• RMT cannot be determined
• Fails TMS safety screening

Sponsors & Collaborators

• Research Grants Council, Hong Kong: collaborator
• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, HongKong, HKG, Hong Kong

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Shuning LI

CONTACT

+852 66770121; shunli.li@connect.polyu.hk

Prof. Marco PANG

CONTACT

+852 2766 7156; marco.pang@polyu.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair professor

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 21, 2026
• Study Start: January 21, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: February 6, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)