Clinical trial NCT06207240: Functional Electrical Stimulation Therapy After Stroke
Official title: Efficacy and Feasibility of Using the NeuroLife Sleeve System to Improve Hand Function in Stroke Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: stroke rehabilitation, functional electrical stimulation
Lead sponsor: Battelle Memorial Institute
Sponsor class: OTHER
First posted: 2024-01-16
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive identical intervention protocols.
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal of this feasibility study is to test the feasibility of providing task-oriented, intention-driven functional electrical stimulation (FES) using the novel NeuroLife FES Sleeve and NeuroLife electromyography (EMG) and FES Sleeve devices in chronic stroke survivors. The main questions it aims to answer are:

* Can these devices be used to administer task-oriented therapy with assistive stimulation at similar doses to current standards of care?
* How does therapy using these devices impact the upper limb function in a few chronic stroke survivors?

Participants will receive assistive electrical stimulation synchronized to their movement intention while practicing functional tasks with everyday objects over the course of 8 weeks.

Detailed description: Battelle has developed the NeuroLife FES Sleeve and NeuroLife EMG-FES Sleeve devices, wearable sleeves that deliver non-invasive functional electrical stimulation (FES) paired with user intention. Participants in this study will use these devices while practicing functional tasks for about one hour at each session. FES will be applied through the forearm sleeve devices to assist with hand movements and grasps required by functional tasks simulating everyday activities such as turning a key or picking up a phone.

Sessions will be scheduled three days per week for 8 weeks total. Participants will complete clinical assessments at the beginning, midpoint and end of intervention as well as at follow-up sessions 2- and 10-weeks after the end of intervention to track upper limb function and impairment. Each session will last 1.5-2 hours, and participants will be compensated for their time.

Eligibility criteria: Inclusion Criteria:

* Males and females ≥18 years old
* Diagnosis of stroke
* Ability to provide appropriate consent to partake in the study
* Ability to follow 3-step commands and deemed by an occupational therapist to have the capacity to complete required upper extremity movements
* Ability to secure transportation to attend scheduled study sessions
* Stroke-related hand impairment that interferes with ability to complete activities of daily living and is classified as Stage 1-6 on the hand subscale of the Chedoke McMaster Stroke Assessment

Exclusion Criteria:

* Presence of any other clinically significant medical comorbidity for which, in the judgment of the Investigator, participation in the study would pose a safety risk to the subject
* Currently participating in physical rehabilitation (e.g., occupational or physical therapy) for stroke-related upper limb impairment
* Co-occurring neurological condition (e.g., Parkinson's disease, Multiple Sclerosis) or other neuromuscular disorder (e.g., Carpal Tunnel Syndrome, neuropathy) that, in the judgment of the Investigator, may influence study results
* Individuals who are immunosuppressed, have conditions that typically result in becoming immunocompromised, taking chronic steroids, or currently receiving immunosuppressive therapy
* Individuals having or requiring any of the following: implanted pacemaker, life supporting/sustaining equipment, or critical non-removable implantable electronic devices such as an insulin pump.
* Persistent pain ≥ 7/10 in impaired upper extremity, as measured by Visual Analogue Scale
* Individuals whose forearm is determined to be too small or too large to fit the electrode sleeve being investigated.
* Individuals who are pregnant or plan to get pregnant during the course of the study.

Primary outcomes:
measure: Action Research Arm Test (ARAT)
timeFrame: Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)
measure: Therapy Dose
timeFrame: Week 0-18 (during the intervention and follow-up periods)
Secondary outcomes:
measure: Fugl-Meyer Assessment-Upper Extremity (UEFM)
timeFrame: Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)
measure: Box and Block Test (BBT)
timeFrame: Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)
measure: Nine-Hole Peg Test (NHPT)
timeFrame: Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)
measure: Motor Activity Log
timeFrame: Week 0-8 (during the intervention period)
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Battelle Memorial Institute
state: Ohio
Study officials:
affiliation: Principal Biomedical Engineer
name: Eric Meyers, PhD
role: PRINCIPAL_INVESTIGATOR
References: