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.

Study Overview

• Status: Not yet recruiting
• Conditions: Stroke
• Intervention / Treatment: Device: Functional Electrical Stimulation Cycling; Behavioral: Cognitive Task Training; Device: Sham Functional Electrical Stimulation Cycling; Device: Transcutaneous Auricular Photobiomodulation; Device: Transcutaneous Forehead Photobiomodulation; Device: Sham Photobiomodulation; Other: Optimal FES Cycling Protocol; Device: Optimal Neuromodulation Protocol

Detailed Description

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
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chia-Ling Chen; Phone Number: 8148 +883-3-3281200; Email: clingchen@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

10

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stage 1: FES Cycling Alone; Participants receive FES-assisted arm cycling.	Device: Functional Electrical Stimulation Cycling; FES-assisted arm cycling is provided for approximately 40 minutes per session, 5 sessions per week for 2 weeks.
Experimental: Stage 1: Dual-Task FES Cycling; Participants receive FES-assisted arm cycling combined with cognitive task training.	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.
Placebo Comparator: Stage 1: Sham FES Cycling; Participants receive sham FES cycling.	Device: Sham Functional Electrical Stimulation Cycling; Participants receive the sham FES cycling control condition.
Experimental: Stage 2: Auricular Photobiomodulation; Participants receive transcutaneous auricular photobiomodulation (taPBM).	Device: Transcutaneous Auricular Photobiomodulation; Photobiomodulation is applied to the outer ear for approximately 20 to 30 minutes.
Experimental: Stage 2: Forehead Photobiomodulation; Participants receive transcutaneous forehead photobiomodulation (tfPBM).	Device: Transcutaneous Forehead Photobiomodulation; Photobiomodulation is applied to the forehead for approximately 20 to 30 minutes.
Placebo Comparator: Stage 2: Sham Photobiomodulation; Participants receive sham photobiomodulation.	Device: Sham Photobiomodulation; Participants receive the sham photobiomodulation control condition.
Experimental: Stage 3: Optimal FES Cycling + Sham Neuromodulation; Participants receive the optimal FES cycling protocol identified in Stage 1 combined with sham neuromodulation.	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.
Experimental: Stage 3: Optimal Neuromodulation + Sham FES Cycling; Participants receive the optimal neuromodulation protocol identified in Stage 2 combined with sham FES cycling.	Device: Sham Functional Electrical Stimulation Cycling; Participants receive the sham FES cycling control condition.; 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).
Experimental: Stage 3: Optimal FES Cycling + Optimal Neuromodulation; Participants receive the optimal FES cycling protocol combined with the optimal neuromodulation protocol.	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).
Placebo Comparator: Stage 3: Sham FES Cycling + Sham Neuromodulation; Participants receive sham FES cycling combined with sham neuromodulation.	Device: Sham Functional Electrical Stimulation Cycling; Participants receive the sham FES cycling control condition.; Device: Sham Photobiomodulation; Participants receive the sham photobiomodulation control condition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Intra-Extra Dimensional Shift (IED)	The IED assesses set-shifting ability and cognitive flexibility. Fewer errors indicate better performance.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Rapid Visual Information Processing (RVP)	The RVP assesses sustained attention. Higher accuracy indicates better sustained attention.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Digit Span Test	The Digit Span Test assesses working memory and sustained attention. Higher span scores indicate stronger working memory and sustained attention.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Fugl-Meyer Assessment-Upper Extremity (FMA-UE)	The FMA-UE assesses upper-extremity motor control. Scores range from 0 to 66, with higher scores indicating better motor control.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Action Research Arm Test (ARAT)	The ARAT assesses upper-limb functional performance. Scores range from 0 to 57, with higher scores indicating better upper-limb function.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment (MoCA)	The MoCA assesses cognitive functioning across domains including attention, executive function, memory, and visuospatial skills. Scores range from 0 to 30, with higher scores indicating better cognitive functioning.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Trail Making Test-Part A (TMT-A)	The TMT-A assesses processing speed and attention. Longer completion times indicate poorer processing speed and attention.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Symbol Digit Modalities Test (SDMT)	The SDMT assesses processing speed. More correct responses indicate better processing speed.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Spatial Working Memory (SWM)	The SWM assesses working memory. Fewer errors indicate better working memory performance.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Paired Associates Learning (PAL)	The PAL assesses visual learning. Fewer errors indicate better visual learning performance.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Modified Ashworth Scale (MAS)	The MAS assesses muscle spasticity. Scores range from 0 to 4, with higher scores indicating greater spasticity.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Grip and Pinch Dynamometry	Grip and pinch dynamometry measures upper-extremity muscle strength. Higher force output indicates greater muscle strength.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Box and Block Test (BBT)	The BBT assesses gross manual dexterity. More blocks transferred indicate better gross manual dexterity.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Nine-Hole Peg Test (9HPT)	The 9HPT assesses fine motor coordination. Shorter completion times indicate better fine motor coordination.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Motor Activity Log (MAL)	The MAL assesses use of the affected arm in daily activities and perceived quality of movement. Scores range from 0 to 5, with higher ratings indicating greater daily arm use and better movement quality.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
ABILHAND Questionnaire	The ABILHAND Questionnaire assesses perceived manual ability in daily activities. Higher logit scores indicate better perceived manual ability.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Functional Independence Measure (FIM)	The FIM assesses functional independence. Scores range from 18 to 126, with higher scores indicating greater functional independence.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Stroke Impact Scale (SIS)	The SIS assesses the impact of stroke on functional recovery. Domain scores range from 0 to 100, with higher scores indicating better functional recovery.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).
Stroke-Specific Quality of Life Scale (SS-QOL)	The SS-QOL assesses stroke-specific health-related quality of life. Higher scores indicate better health-related quality of life.	Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital
• Investigators: Study Director: Chia-Ling Chen, Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: September 2, 2026
• First Submitted That Met QC Criteria: September 2, 2026
• First Posted (Actual): September 8, 2026

Study Record Updates

• Last Update Posted (Actual): September 8, 2026
• Last Update Submitted That Met QC Criteria: September 2, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: Neuromodulation; Photobiomodulation; Stroke Rehabilitation; Functional Electrical Stimulation; Upper Extremity Rehabilitation; FES Cycling; Dual-Task Training; Cognitive-Motor Performance; Cognitive Task Training
• Additional Relevant MeSH Terms: Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Stroke
• Other Study ID Numbers: 202502050A3

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No