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NCT07356687
Effects of rTMS Combined With Dual-Task Gait Training on Walking and Cognition After Stroke
Conditions: Stroke
Sex: All
Ages: 50 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 184
Sponsor: The Hong Kong Polytechnic University
Location: The Hong Kong Polytechnic University Hong Kong HongKong
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07356687). StuddyBuddy aggregates publicly available trial information.