Functional Electrical Stimulation Therapy After Stroke

Battelle Memorial Institute

Status: Completed

Conditions: Stroke

Treatments: Device: NeuroLife FES Sleeve / NeuroLife EMG-FES Sleeve

Study type: Interventional

Funder types: Other

Identifiers

NCT06207240

0828-RD0001.22

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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2 participants in 1 patient group

FES Therapy

Experimental group

Description:

Intention-driven assistive functional electrical stimulation provided during approximately 1 hour of task-oriented therapy. Sessions will be scheduled 3 days per week for 8 weeks.

Treatment:

Device: NeuroLife FES Sleeve / NeuroLife EMG-FES Sleeve