StrokeNCT06207240
Functional Electrical Stimulation Therapy After Stroke
A study testing NeuroLife FES Sleeve / NeuroLife EMG-FES Sleeve in people with Stroke, run by Battelle Memorial Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- NeuroLife FES Sleeve / NeuroLife EMG-FES Sleeve
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2022to 8 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Feasibility of Using the NeuroLife Sleeve System to Improve Hand Function in Stroke Survivors
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.
Read the 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.
- Conditions
- Stroke
- Being tested
- NeuroLife FES Sleeve / NeuroLife EMG-FES Sleeve
- Keywords
- stroke rehabilitation, functional electrical stimulation
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroLife FES Sleeve / NeuroLife EMG-FES SleeveDevice
Also called Functional Electrical Stimulation Therapy (FEST)
Electrical stimulation will be delivered via the NeuroLife FES Sleeve and NeuroLife EMG-FES Sleeve devices to assist with movement during functional task practice.
| Study group | Role | What they receive |
|---|---|---|
| FES Therapy | Experimental | 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. Receives: Device: NeuroLife FES Sleeve / NeuroLife EMG-FES Sleeve |
What is being measured
The primary outcome is the main question the study is designed to answer.
Action Research Arm Test (ARAT)
The Action Research Arm Test (ARAT) will be used to track functional changes from the pre-intervention baseline. The ARAT is a common measure of upper extremity function after stroke ranging from 0 (maximal impairment) to 57 (no impairment).
Measured: Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)
Therapy Dose
Therapy Dose was used to estimate the feasibility of the therapy. Therapy Dose will be computed as the average amount of time at each session the subject was engaged in intention-driven, task-oriented functional electrical stimulation therapy, excluding the time needed to set up the system.
Measured: Week 0-18 (during the intervention and follow-up periods)
Secondary outcomes (4)
Fugl-Meyer Assessment-Upper Extremity (UEFM)
The Fugl-Meyer Assessment-Upper Extremity (UEFM) subscore will be used to track impairment changes from the pre-intervention baseline. The UEFM is a common measure of upper extremity impairment after stroke ranging from 0 (maximal impairment) to 66 (no impairment).
Measured: Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)
Box and Block Test (BBT)
The Box and Block Test (BBT) will be used to track dexterity changes from the pre-intervention baseline. The BBT is a common measure of unilateral gross manual dexterity after stroke quantified by the number of blocks transferred between boxes within 60 seconds.
Measured: Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)
Nine-Hole Peg Test (NHPT)
The Nine-Hole Peg Test (NHPT) will be used to track dexterity changes from the pre-intervention baseline. The NHPT is a common measure of unilateral manual dexterity after stroke quantified by the time taken to transfer nine pegs from holes to a dish.
Measured: Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)
Motor Activity Log
The Motor Activity Log (MAL) will be used to track participants' use of their impaired arm throughout the study. The MAL is widely used to assess how stroke survivors use their more-impaired arm outside the laboratory through semi-structured interviews capturing the amount of use and quality of movement using their arm.
Measured: Week 0-8 (during the intervention period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2024
- Study start18 Jan 2022
- Primary completion8 Jun 2022
- Study completion8 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive identical intervention protocols.
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Battelle Memorial Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric Meyers, PhD, Principal investigator, Principal Biomedical Engineer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06207240
- Sponsor's protocol ID
- 0828-RD0001.22
- Status last verified
- Jan 2024
- First submitted
- 3 Jan 2024
- Last updated
- 16 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Baumgart IW, Darrow MJ, Tacca NJ, Dunlap CF, Colachis SC 4th, Kamath A, Schlink BR, Putnam PT, Branch J, Friedenberg DA, Wengerd LR, Meyers EC. Intention-driven functional electrical stimulation therapy using a wearable high-density electrode sleeve in chronic stroke: a case report. J Neuroeng Rehabil. 2026 Jun 24. doi: 10.1186/s12984-026-02051-1. Online ahead of print.
PubMed 42343330
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Feasibility of Using the NeuroLife Sleeve System to Improve Hand Function in Stroke Survivors
- ClinicalTrials.gov ID
- NCT06207240
- Acronym / sponsor ID
- 0828-RD0001.22
- Conditions
- Stroke
- Keywords
- stroke rehabilitation, functional electrical stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Battelle Memorial InstituteUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 8 Jun 2022 (actual)
- Study completion
- 8 Jun 2022 (actual)
- First posted
- 16 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive identical intervention protocols.
| Arm | Type | Receives |
|---|---|---|
| FES Therapy | Experimental | Device: NeuroLife FES Sleeve / NeuroLife EMG-FES SleeveIntention-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NeuroLife FES Sleeve / NeuroLife EMG-FES SleeveAlso: Functional Electrical Stimulation Therapy (FEST)Electrical stimulation will be delivered via the NeuroLife FES Sleeve and NeuroLife EMG-FES Sleeve devices to assist with movement during functional task practice. | Device | FES Therapy |
Primary outcome
Action Research Arm Test (ARAT)
Time frame: Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)
The Action Research Arm Test (ARAT) will be used to track functional changes from the pre-intervention baseline. The ARAT is a common measure of upper extremity function after stroke ranging from 0 (maximal impairment) to 57 (no impairment).
Therapy Dose
Time frame: Week 0-18 (during the intervention and follow-up periods)
Therapy Dose was used to estimate the feasibility of the therapy. Therapy Dose will be computed as the average amount of time at each session the subject was engaged in intention-driven, task-oriented functional electrical stimulation therapy, excluding the time needed to set up the system.
4 secondary outcomes
Fugl-Meyer Assessment-Upper Extremity (UEFM)
Time frame: Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)
Box and Block Test (BBT)
Time frame: Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)
Nine-Hole Peg Test (NHPT)
Time frame: Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)
Motor Activity Log
Time frame: Week 0-8 (during the intervention period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2024.
- Derived from this study: PubMed 42343330Baumgart IW, Darrow MJ, Tacca NJ, Dunlap CF, Colachis SC 4th, Kamath A, Schlink BR, Putnam PT, Branch J, Friedenberg DA, Wengerd LR, Meyers EC. Intention-driven functional electrical stimulation therapy using a wearable high-density electrode sleeve in chronic stroke: a case report. J Neuroeng Rehabil. 2026 Jun 24. doi: 10.1186/s12984-026-02051-1. Online ahead of print.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Meyers, PhD principal investigator
Principal Biomedical Engineer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NeuroLife FES Sleeve / NeuroLife EMG-FES Sleeve in people with Stroke, run by Battelle Memorial Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Action Research Arm Test (ARAT) (time frame: Week 0 (Baseline), Week 4 (Mid-Intervention), Week 8 (Post-Intervention), Week 10 (2-Week Follow Up), Week 18 (10-Week Follow Up)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06207240, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jan 2024; AzTrials last refreshed its copy on 31 Oct 2026.