Neuromodulation Combined With Dual FES Cycling and Cognitive Training After Stroke
ConditionStroke
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorChang Gung Memorial Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Functional Electrical Stimulation Cycling
DeviceFES-assisted arm cycling is provided for approximately 40 minutes per session, 5 sessions per week for 2 weeks.
Cognitive Task Training
BehavioralCognitive tasks are performed during FES cycling and progressively target attention, working memory, and executive control.
Transcutaneous Auricular Photobiomodulation
DevicePhotobiomodulation is applied to the outer ear for approximately 20 to 30 minutes.
Transcutaneous Forehead Photobiomodulation
DevicePhotobiomodulation is applied to the forehead for approximately 20 to 30 minutes.
Sham Functional Electrical Stimulation Cycling
DeviceParticipants receive the sham FES cycling control condition.
Sham Photobiomodulation
DeviceParticipants receive the sham photobiomodulation control condition.
Optimal FES Cycling Protocol
Other interventionThe 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 Protocol
DeviceThe 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).
Treatment groups
150 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Group A: Stage 1: FES Cycling AloneExperimental treatment 1 intervention
Group B: Stage 1: Dual-Task FES CyclingExperimental treatment 2 interventions
Group C: Stage 1: Sham FES CyclingPlacebo comparator 1 intervention
Group D: Stage 2: Auricular PhotobiomodulationExperimental treatment 1 intervention
Group E: Stage 2: Forehead PhotobiomodulationExperimental treatment 1 intervention
Group F: Stage 2: Sham PhotobiomodulationPlacebo comparator 1 intervention
Group G: Stage 3: Optimal FES Cycling + Sham NeuromodulationExperimental treatment 2 interventions
Group H: Stage 3: Optimal Neuromodulation + Sham FES CyclingExperimental treatment 2 interventions
Group I: Stage 3: Optimal FES Cycling + Optimal NeuromodulationExperimental treatment 2 interventions
Group J: Stage 3: Sham FES Cycling + Sham NeuromodulationPlacebo comparator 2 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).2
Intra-Extra Dimensional Shift (IED)
The IED assesses set-shifting ability and cognitive flexibility. Fewer errors indicate better performance.
Time frame
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).3
Rapid Visual Information Processing (RVP)
The RVP assesses sustained attention. Higher accuracy indicates better sustained attention.
Time frame
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).4
Digit Span Test
The Digit Span Test assesses working memory and sustained attention. Higher span scores indicate stronger working memory and sustained attention.
Time frame
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).Secondary outcomes
1
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.
Time frame
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).2
Trail Making Test-Part A (TMT-A)
The TMT-A assesses processing speed and attention. Longer completion times indicate poorer processing speed and attention.
Time frame
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).3
Symbol Digit Modalities Test (SDMT)
The SDMT assesses processing speed. More correct responses indicate better processing speed.
Time frame
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).4
Spatial Working Memory (SWM)
The SWM assesses working memory. Fewer errors indicate better working memory performance.
Time frame
Baseline (T0), immediately after the 2-week intervention (T1), and 3-month follow-up (T2).Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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