StrokeNCT07147881
Prospective Real-World Evidence Study of the IpsiHand® System in Adult Stroke Survivors
An observational study of Stroke and Hemiparesis After Stroke, run by Neurolutions, Inc..
Trial summary
This study focuses on monitoring real-world customers who have been prescribed the IpsiHand® as part of their rehabilitation post-stroke. This study aims to evaluate their progress over time, assessing motor recovery, functional independence in activities of daily living (ADLs), caregiver burden, and health economic… Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Stroke, Hemiparesis After Stroke, Brain Computer Interface
- What is being tested?
- IpsiHand
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 1 Jan 2028
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic stroke patients (≥ 6 months post-stroke) age 18 or older undergoing rehabilitation using the IpsiHand® System.
Who may be able to join
- Adult age 18-85 years.
- Diagnosis of stroke six or more months prior with upper extremity weakness.
- Has received an IpsiHand® system as a commercial customer for stroke rehabilitation.
Who cannot join
- Severe cognitive impairment that would impede utilization of IpsiHand®
- Any contraindications to IpsiHand® device use
- Inability to comprehend English
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study focuses on monitoring real-world customers who have been prescribed the IpsiHand® as part of their rehabilitation post-stroke. This study aims to evaluate their progress over time, assessing motor recovery, functional independence in activities of daily living (ADLs), caregiver burden, and health economic outcomes.
Read the detailed description
IpsiHand® is an FDA-authorized, non-invasive, BCI-based device that is indicated for use in chronic stroke patients (≥ 6 months post stroke) age 18 or older undergoing stroke rehabilitation, to facilitate muscle re-education and for maintaining or increasing range of motion in the upper extremity. Through utilization of EEG signals from the unaffected side of the brain, the device enables stroke survivors to control a robotic hand orthosis, facilitating functional reorganization of the brain and improved motor recovery.
- Conditions
- Stroke, Hemiparesis After Stroke, Brain Computer Interface
- Being tested
- IpsiHand
- Keywords
- Neurolutions, IpsiHand, Stroke, Hemiparesis after stroke, BCI
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpsiHandDevice
Also called IpsiHand Therapy, BCI Therapy
IpsiHand is a therapeutic device that uses a brain-computer interface system which detects neural signals associated with motor intent and translates them into assisted hand movements in individuals with upper extremity impairment following a stroke.
| Study group | Role | What they receive |
|---|---|---|
| Adult stroke patients with upper extremity hemiparesis. | Chronic Stroke Patients (≥ 6 months post-stroke) age 18 or older undergoing stroke rehabilitation with use of the IpsiHand® System. Receives: Device: IpsiHand |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer - Upper Extremity (FM-UE) , Manual Long Form
Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
Measured: Baseline visit and at 4-week, 8-week, 12-week, 16-week, 20-week, 24-week, 28-week, 32-week, 36-week, 12-months, and 24 months of IpsiHand® device use, or until completion of IpsiHand® device use if occurring prior to 24 months.
Secondary outcomes (4)
The Barthel Index
Assessment tool that measures a person's functional independence in activities of daily living and self-care.
Measured: Baseline visit and at 4-week, 8-week, 12-week, 16-week, 20-week, 24-week, 28-week, 32-week, 36-week, 12-months, and 24 months of IpsiHand® device use, or until completion of IpsiHand® device use if occurring prior to 24 months.
Zarit Caregiver Burden Scale (ZBI)
Widely used questionnaire designed to assess the level of burden experienced by caregivers.
Measured: Baseline Visit, 12-Week, 24-Week, 36 Week, 12-Months, and 24-Months post-use of IpsiHand Device or at time of completion of IpsiHand device use if occurring prior to 24-Months.
Patient Specific Functional Scale (PSFS)
patient-reported outcome measure used to assess an individual's ability to perform specific functional activities that are important to them. It is commonly used in rehabilitation and clinical settings to track progress over time in response to treatment.
Measured: Baseline visit and at 4-week, 8-week, 12-week, 16-week, 20-week, 24-week, 28-week, 32-week, 36-week, 12-months, and 24 months of IpsiHand® device use, or until completion of IpsiHand® device use if occurring prior to 24 months.
Euro-QOL5D5L
Patient-reported outcome measure used to assess health-related quality of life (HRQoL) across different diseases and treatments. It is widely used in clinical research, health economics, and healthcare decision-making to quantify the impact of health conditions and interventions on daily living
Measured: Baseline Visit, 12-Week, 24-Week, 36 Week, 12-Months, and 24-Months post-use of IpsiHand Device or at time of completion of IpsiHand device use if occurring prior to 24-Months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Neurolutions, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Seth Wilk, PhD, Principal investigator, Neurolutions, Inc.Lee Fleisher, MD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07147881
- Sponsor's protocol ID
- RWE_002
- Status last verified
- Aug 2025
- First submitted
- 22 Aug 2025
- Last updated
- 29 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Individual Participant Data (IPD) will not be shared because the dataset contains protected health information from routine clinical care. Even with de-identification, there remains a risk of re-identification, and confidentiality obligations under HIPAA and applicable privacy laws prevent sharing.
Publications
Rustamov N, Humphries J, Carter A, Leuthardt EC. Theta-gamma coupling as a cortical biomarker of brain-computer interface-mediated motor recovery in chronic stroke. Brain Commun. 2022 May 25;4(3):fcac136. doi: 10.1093/braincomms/fcac136. eCollection 2022.
PubMed 35702730Rustamov N, Souders L, Sheehan L, Carter A, Leuthardt EC. IpsiHand Brain-Computer Interface Therapy Induces Broad Upper Extremity Motor Recovery in Chronic Stroke. medRxiv [Preprint]. 2023 Aug 28:2023.08.26.23294320. doi: 10.1101/2023.08.26.23294320.
PubMed 37693482Bundy DT, Souders L, Baranyai K, Leonard L, Schalk G, Coker R, Moran DW, Huskey T, Leuthardt EC. Contralesional Brain-Computer Interface Control of a Powered Exoskeleton for Motor Recovery in Chronic Stroke Survivors. Stroke. 2017 Jul;48(7):1908-1915. doi: 10.1161/STROKEAHA.116.016304. Epub 2017 May 26.
PubMed 28550098
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Real-World Evidence Study of the IpsiHand® System in Adult Stroke Survivors
- ClinicalTrials.gov ID
- NCT07147881
- Acronym / sponsor ID
- RWE_002
- Conditions
- Stroke, Hemiparesis After Stroke, Brain Computer Interface
- Keywords
- Neurolutions, IpsiHand, Stroke, Hemiparesis after stroke, BCI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Neurolutions, Inc.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 29 Aug 2025 (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.
This study focuses on monitoring real-world customers who have been prescribed the IpsiHand® as part of their rehabilitation post-stroke. This study aims to evaluate their progress over time, assessing motor recovery, functional independence in activities of daily living (ADLs), caregiver burden, and health economic outcomes.
Detailed description
IpsiHand® is an FDA-authorized, non-invasive, BCI-based device that is indicated for use in chronic stroke patients (≥ 6 months post stroke) age 18 or older undergoing stroke rehabilitation, to facilitate muscle re-education and for maintaining or increasing range of motion in the upper extremity. Through utilization of EEG signals from the unaffected side of the brain, the device enables stroke survivors to control a robotic hand orthosis, facilitating functional reorganization of the brain and improved motor recovery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult stroke patients with upper extremity hemiparesis. | – | Device: IpsiHandChronic Stroke Patients (≥ 6 months post-stroke) age 18 or older undergoing stroke rehabilitation with use of the IpsiHand® System. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic stroke patients (≥ 6 months post-stroke) age 18 or older undergoing rehabilitation using the IpsiHand® System.
Key inclusion criteria (3 listed)
- Adult age 18-85 years.
- Diagnosis of stroke six or more months prior with upper extremity weakness.
- Has received an IpsiHand® system as a commercial customer for stroke rehabilitation.
Key exclusion criteria (3 listed)
- Severe cognitive impairment that would impede utilization of IpsiHand®
- Any contraindications to IpsiHand® device use
- Inability to comprehend English
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 |
|---|---|---|
| IpsiHandAlso: IpsiHand Therapy, BCI TherapyIpsiHand is a therapeutic device that uses a brain-computer interface system which detects neural signals associated with motor intent and translates them into assisted hand movements in individuals with upper extremity impairment following a stroke. | Device | Adult stroke patients with upper extremity hemiparesis. |
Primary outcome
Fugl-Meyer - Upper Extremity (FM-UE) , Manual Long Form
Time frame: Baseline visit and at 4-week, 8-week, 12-week, 16-week, 20-week, 24-week, 28-week, 32-week, 36-week, 12-months, and 24 months of IpsiHand® device use, or until completion of IpsiHand® device use if occurring prior to 24 months.
Valid assessment tool of upper extremity motor function in persons chronic stroke with moderate to severe deficits. Lowest score 0, highest score 66.
4 secondary outcomes
The Barthel Index
Time frame: Baseline visit and at 4-week, 8-week, 12-week, 16-week, 20-week, 24-week, 28-week, 32-week, 36-week, 12-months, and 24 months of IpsiHand® device use, or until completion of IpsiHand® device use if occurring prior to 24 months.
Zarit Caregiver Burden Scale (ZBI)
Time frame: Baseline Visit, 12-Week, 24-Week, 36 Week, 12-Months, and 24-Months post-use of IpsiHand Device or at time of completion of IpsiHand device use if occurring prior to 24-Months.
Patient Specific Functional Scale (PSFS)
Time frame: Baseline visit and at 4-week, 8-week, 12-week, 16-week, 20-week, 24-week, 28-week, 32-week, 36-week, 12-months, and 24 months of IpsiHand® device use, or until completion of IpsiHand® device use if occurring prior to 24 months.
Euro-QOL5D5L
Time frame: Baseline Visit, 12-Week, 24-Week, 36 Week, 12-Months, and 24-Months post-use of IpsiHand Device or at time of completion of IpsiHand device use if occurring prior to 24-Months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2025.
- Background: PubMed 35702730Rustamov N, Humphries J, Carter A, Leuthardt EC. Theta-gamma coupling as a cortical biomarker of brain-computer interface-mediated motor recovery in chronic stroke. Brain Commun. 2022 May 25;4(3):fcac136. doi: 10.1093/braincomms/fcac136. eCollection 2022.
- Background: PubMed 37693482Rustamov N, Souders L, Sheehan L, Carter A, Leuthardt EC. IpsiHand Brain-Computer Interface Therapy Induces Broad Upper Extremity Motor Recovery in Chronic Stroke. medRxiv [Preprint]. 2023 Aug 28:2023.08.26.23294320. doi: 10.1101/2023.08.26.23294320.
- Background: PubMed 28550098Bundy DT, Souders L, Baranyai K, Leonard L, Schalk G, Coker R, Moran DW, Huskey T, Leuthardt EC. Contralesional Brain-Computer Interface Control of a Powered Exoskeleton for Motor Recovery in Chronic Stroke Survivors. Stroke. 2017 Jul;48(7):1908-1915. doi: 10.1161/STROKEAHA.116.016304. Epub 2017 May 26.
- FDA De Novo AuthorizationLink provided by the sponsor.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be shared because the dataset contains protected health information from routine clinical care. Even with de-identification, there remains a risk of re-identification, and confidentiality obligations under HIPAA and applicable privacy laws prevent sharing.
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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.
Seth Wilk, PhD principal investigator
Neurolutions, Inc.
Lee Fleisher, MD principal investigator
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Hemiparesis After Stroke, run by Neurolutions, Inc..
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 29 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lauren Souders, MOT, OTR/L, CBIS, CSRS (213-286-3323, innovation@kandu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fugl-Meyer - Upper Extremity (FM-UE) , Manual Long Form (time frame: Baseline visit and at 4-week, 8-week, 12-week, 16-week, 20-week, 24-week, 28-week, 32-week, 36-week, 12-months, and 24 months of IpsiHand® device use, or until completion of IpsiHand® device use if occurring prior to 24 months.). 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 NCT07147881, which also lists 3 linked publications.
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 29 Aug 2025.