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NOT YET RECRUITING
NCT07807176
NA

Neuromodulation Combined With Dual FES Cycling and Cognitive Training After Stroke

Sponsor: Chang Gung Memorial Hospital

View on ClinicalTrials.gov

Summary

This study will evaluate the effects of functional electrical stimulation (FES) cycling, cognitive task training, and non-invasive photobiomodulation on cognitive and upper-limb motor performance in adults after stroke. The study includes three stages to identify favorable FES cycling and neuromodulation approaches and to evaluate their combined effects. Participants will complete 10 intervention sessions over 2 weeks. Cognitive and motor outcomes will be assessed before treatment, immediately after treatment, and at 3-month follow-up. Feasibility, tolerance, and adverse events will also be evaluated.

Official title: Exploratory Evaluation of Neuromodulation Combined With Dual Functional Electrical Stimulation Cycling and Cognitive Task Training on Cognitive-Motor Performance in Individuals After Stroke

Key Details

Gender

All

Age Range

20 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2026-10-01

Completion Date

2028-10-01

Last Updated

2026-09-08

Healthy Volunteers

No

Conditions

Interventions

DEVICE

Functional Electrical Stimulation Cycling

FES-assisted arm cycling is provided for approximately 40 minutes per session, 5 sessions per week for 2 weeks.

BEHAVIORAL

Cognitive Task Training

Cognitive tasks are performed during FES cycling and progressively target attention, working memory, and executive control.

DEVICE

Transcutaneous Auricular Photobiomodulation

Photobiomodulation is applied to the outer ear for approximately 20 to 30 minutes.

DEVICE

Transcutaneous Forehead Photobiomodulation

Photobiomodulation is applied to the forehead for approximately 20 to 30 minutes.

DEVICE

Sham Functional Electrical Stimulation Cycling

Participants receive the sham FES cycling control condition.

DEVICE

Sham Photobiomodulation

Participants receive the sham photobiomodulation control condition.

OTHER

Optimal FES Cycling Protocol

The FES cycling condition associated with the most favorable cognitive-motor performance pattern in Stage 1 will be selected for use in Stage 3. The selected protocol will consist of either FES cycling alone or FES cycling combined with cognitive task training.

DEVICE

Optimal Neuromodulation Protocol

The photobiomodulation condition associated with the most favorable cognitive-motor performance pattern in Stage 2 will be selected for use in Stage 3. The selected protocol will consist of either transcutaneous auricular photobiomodulation (taPBM) or transcutaneous forehead photobiomodulation (tfPBM).