Neuromodulation Combined With Dual FES Cycling and Cognitive Training After Stroke

N/ANot Yet RecruitingNCT07807176

Chang Gung Memorial Hospital150 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

150

Conditions

Stroke

Interventions

Functional Electrical Stimulation CyclingDEVICE

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

Cognitive Task TrainingBEHAVIORAL

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

Transcutaneous Auricular PhotobiomodulationDEVICE

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

Transcutaneous Forehead PhotobiomodulationDEVICE

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

Sham Functional Electrical Stimulation CyclingDEVICE

Participants receive the sham FES cycling control condition.

Sham PhotobiomodulationDEVICE

Participants receive the sham photobiomodulation control condition.

Optimal FES Cycling ProtocolOTHER

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.

Optimal Neuromodulation ProtocolDEVICE

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).

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Trail Making Test-Part B (TMT-B)

The TMT-B assesses executive function and cognitive flexibility. Longer completion times indicate poorer executive function and cognitive flexibility.