Neuromodulation Combined With Dual FES Cycling and Cognitive Training After Stroke

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

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.

This is a three-stage, randomized, sham-controlled study in individuals after stroke. Stage 1 will compare FES cycling alone, FES cycling combined with cognitive task training, and sham FES cycling. Stage 2 will compare photobiomodulation applied to the ear, forehead, and sham stimulation. Stage 3 will evaluate the selected FES cycling and neuromodulation approaches alone and in combination. Participants will complete 10 sessions over 2 weeks. Cognitive, upper-extremity motor, functional, participation, and quality-of-life outcomes will be assessed at baseline, immediately after treatment, and at 3-month follow-up. Feasibility, adherence, tolerance, and adverse events will also be monitored.

Inclusion Criteria:

• Adults aged 20 to 80 years.
• First-ever ischemic or hemorrhagic stroke with unilateral impairment in hand or arm strength or motor function.
• Medically stable and able to participate safely in the training program.
• Able to understand the study procedures and sign the informed consent form.
• Able to follow verbal instructions, comply with study procedures, and complete all assessments.
• Able to maintain a seated position and participate in each training session (approximately 40-60 minutes).

Exclusion Criteria:

• Stroke involving the brainstem or cerebellum.
• History of epilepsy, photosensitive epilepsy, or a tendency to faint.
• Presence of implanted electronic devices, such as pacemakers, implantable cardioverter-defibrillators (ICD), or other electronic medical implants (e.g., artificial heart, infusion pumps, cochlear implants).
• Wounds, infections, or significant skin problems at potential stimulation sites (ear or scalp).
• Presence of major psychiatric disorders or inability to understand or cooperate with testing.
• Cardiovascular or vascular-related conditions, including severe heart disease, uncontrolled arrhythmia, or medical advice against exercise; use of anticoagulant medication that makes laser stimulation inappropriate.
• Acute illness, such as fever or active infection.
• Botulinum toxin injections or relevant surgeries within the past six months.
• Photosensitive disorders (e.g., lupus, porphyria) or current use of photosensitizing medications.
• Inability to safely perform cycling training (e.g., recent fractures, severe spasticity, difficulty maintaining seated posture).
• Pregnant or breastfeeding individuals.
• Any other condition deemed unsuitable by the study physician (e.g., severe claustrophobia).