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

The Hong Kong Polytechnic University

Status: Enrolling

Conditions: Stroke

Treatments: Other: active rTMS with dual-task training; Other: sham rTMS with dual-task training

Study type: Interventional

Funder types: Other

Identifiers

NCT07356687

HSEARS20250731004

Details and patient eligibility

About

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.

Full description

Cognitive-motor interference after stroke can reduce walking safety and functional independence, especially during everyday dual-task situations. Dual-task gait training can improve performance, but response varies, potentially due to limitations in executive control and prefrontal network engagement. The DLPFC is central to attention and executive function; therefore, rTMS targeting the DLPFC may prime relevant neural circuits and improve responsiveness to subsequent dual-task training.

This study is a parallel-group, randomized, double-blind, placebo-controlled trial. Community dwelling adults with chronic unilateral stroke will be recruited and randomized 1:1. Participants and outcome assessors will be blinded.

Both groups will complete 12 supervised sessions over 3 weeks. In each session, participants will first receive either: Active rTMS to the DLPFC of the affected hemisphere (5 Hz; 90% resting motor threshold; total 1,200 pulses), or Sham rTMS using the placebo side of the coil with similar auditory sensations.

Dual-task gait training will begin shortly after stimulation. Training will combine functional walking/balance tasks with progressively challenging cognitive tasks (e.g., mental arithmetic, verbal fluency, working memory tasks, and a shopping-list recall task), with difficulty adjusted to participant ability.

Assessments will be conducted at baseline, post-intervention, and 4-week follow-up. Co-primary outcomes are DTC of gait speed and cognitive performance during dual-task walking.

Enrollment: 184 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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184 participants in 2 patient groups

active rTMS with dual-task training

Experimental group

Description:

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)

Treatment:

Other: active rTMS with dual-task training

sham rTMS with dual-task training

Active Comparator group

Description:

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).

Treatment:

Other: sham rTMS with dual-task training