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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Hong Kong Special Administrative Region
The Hong Kong Polytechnic University
RECRUITING
Hong Kong
Contact Information
Primary
Shuning LI
shunli.li@connect.polyu.hk
+852 66770121
Backup
Prof. Marco PANG
marco.pang@polyu.edu.hk
+852 2766 7156
Time Frame
Start Date: 2026-01-21
Estimated Completion Date: 2029-01
Participants
Target number of participants: 184
Treatments
Experimental: active rTMS with dual-task training
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)
Active_comparator: sham rTMS with dual-task training
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).
Related Therapeutic Areas
Sponsors
Collaborators: Research Grants Council, Hong Kong
Leads: The Hong Kong Polytechnic University

This content was sourced from clinicaltrials.gov