Neuromodulation Combined With Dual FES Cycling and Cognitive Training After Stroke

NCT07807176 | Not Yet Recruiting DMC

• 1 other identifier: 202502050A3
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stroke

Keywords

Functional Electrical Stimulation; FES Cycling; Photobiomodulation; Neuromodulation; Cognitive Task Training; Dual-Task Training; Upper Extremity Rehabilitation; Cognitive-Motor Performance; Stroke Rehabilitation

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (14)

• Montreal Cognitive Assessment (MoCA)

  Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

• Trail Making Test-Part A (TMT-A)

  Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

• Symbol Digit Modalities Test (SDMT)

  Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

• Spatial Working Memory (SWM)

  Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

• Paired Associates Learning (PAL)

  Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).

Study Arms (10)

Stage 1: FES Cycling Alone

EXPERIMENTAL

Participants receive FES-assisted arm cycling.

Device: Functional Electrical Stimulation Cycling

Stage 1: Dual-Task FES Cycling

EXPERIMENTAL

Participants receive FES-assisted arm cycling combined with cognitive task training.

Device: Functional Electrical Stimulation Cycling; Behavioral: Cognitive Task Training

Stage 1: Sham FES Cycling

PLACEBO COMPARATOR

Participants receive sham FES cycling.

Device: Sham Functional Electrical Stimulation Cycling

Stage 2: Auricular Photobiomodulation

EXPERIMENTAL

Participants receive transcutaneous auricular photobiomodulation (taPBM).

Device: Transcutaneous Auricular Photobiomodulation

Stage 2: Forehead Photobiomodulation

EXPERIMENTAL

Participants receive transcutaneous forehead photobiomodulation (tfPBM).

Device: Transcutaneous Forehead Photobiomodulation

Stage 2: Sham Photobiomodulation

PLACEBO COMPARATOR

Participants receive sham photobiomodulation.

Device: Sham Photobiomodulation

Stage 3: Optimal FES Cycling + Sham Neuromodulation

EXPERIMENTAL

Participants receive the optimal FES cycling protocol identified in Stage 1 combined with sham neuromodulation.

Device: Sham Photobiomodulation; Other: Optimal FES Cycling Protocol

Stage 3: Optimal Neuromodulation + Sham FES Cycling

EXPERIMENTAL

Participants receive the optimal neuromodulation protocol identified in Stage 2 combined with sham FES cycling.

Device: Sham Functional Electrical Stimulation Cycling; Device: Optimal Neuromodulation Protocol

Stage 3: Optimal FES Cycling + Optimal Neuromodulation

EXPERIMENTAL

Participants receive the optimal FES cycling protocol combined with the optimal neuromodulation protocol.

Other: Optimal FES Cycling Protocol; Device: Optimal Neuromodulation Protocol

Stage 3: Sham FES Cycling + Sham Neuromodulation

PLACEBO COMPARATOR

Participants receive sham FES cycling combined with sham neuromodulation.

Device: Sham Functional Electrical Stimulation Cycling; Device: Sham Photobiomodulation

Interventions

Cognitive Task Training BEHAVIORAL

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

Stage 1: Dual-Task FES Cycling

Transcutaneous Forehead Photobiomodulation DEVICE

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

Stage 2: Forehead Photobiomodulation

Sham Photobiomodulation DEVICE

Participants receive the sham photobiomodulation control condition.

Stage 2: Sham Photobiomodulation; Stage 3: Optimal FES Cycling + Sham Neuromodulation; Stage 3: Sham FES Cycling + Sham Neuromodulation

Optimal FES Cycling Protocol OTHER

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.

Stage 3: Optimal FES Cycling + Optimal Neuromodulation; Stage 3: Optimal FES Cycling + Sham Neuromodulation

Optimal Neuromodulation Protocol DEVICE

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).

Stage 3: Optimal FES Cycling + Optimal Neuromodulation; Stage 3: Optimal Neuromodulation + Sham FES Cycling

Transcutaneous Auricular Photobiomodulation DEVICE

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

Stage 2: Auricular Photobiomodulation

Functional Electrical Stimulation Cycling DEVICE

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

Stage 1: Dual-Task FES Cycling; Stage 1: FES Cycling Alone

Sham Functional Electrical Stimulation Cycling DEVICE

Participants receive the sham FES cycling control condition.

Stage 1: Sham FES Cycling; Stage 3: Optimal Neuromodulation + Sham FES Cycling; Stage 3: Sham FES Cycling + Sham Neuromodulation

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Chia-Ling Chen

  Chang Gung Memorial Hospital

  STUDY DIRECTOR

Central Study Contacts

Chia-Ling Chen

CONTACT

+883-3-3281200; clingchen@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 8, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): October 1, 2028
• Last Updated: September 8, 2026

Record last verified: 2026-09