Neuromodulation Combined With Dual FES Cycling and Cognitive Training After Stroke

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).