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

Official title

Effects of Dorsolateral Prefrontal Cortex rTMS Primed Dual-Task Gait Training on Walking and Cognitive Outcomes After Stroke: A Randomized Sham-Controlled Trial

Overview

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.

Detailed 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.

Interventions

• Other active rTMS with dual-task training
  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.
• Other sham rTMS with dual-task training
  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.

Primary outcome measures

• Dual-task cost (DTC) of walking speed (%) [Time frame: 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 (%) [Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)]

Secondary outcome measures (12)

• Timed Up and Go (TUG) time (seconds) [Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)]
• Mini-BESTest total score [Time frame: 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 [Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)]
• Fall incidence (number of falls) [Time frame: During 12 months post-intervention follow-up]
• Stride length (cm) [Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)]
• Reintegration to Normal Living Index (RNLI) score [Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)]
• Cadence (steps/min) [Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)]
• Double support time (%) [Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)]
• Gait Speed (m/s) [Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)]
• Foot Strike Angle (degrees) [Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)]
• Turns - Duration (seconds) [Time frame: Baseline (pre-intervention), 1-week post-intervention (Week 4), and 4-week post-intervention follow-up (Week 8)]
• Session-level perceived fatigue (0-10 rating) [Time frame: Before and after each training session (3 weeks)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

Hong Kong · 1 center

• The Hong Kong Polytechnic University — Hong Kong

Identifiers

NCT: NCT07356687 · HSEARS20250731004

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗