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This study focuses on monitoring real-world customers who have been prescribed the IpsiHandĀ® 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.
IpsiHandĀ® is an FDA-authorized, non-invasive, BCI-based device that is indicated for use in chronic stroke patients (ā„ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult stroke patients with upper extremity hemiparesis. | Chronic Stroke Patients (ā„ 6 months post-stroke) age 18 or older undergoing stroke rehabilitation with use of the IpsiHandĀ® System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IpsiHand | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 IpsiHandĀ® device use, or until completion of IpsiHandĀ® device use if occurring prior to 24 months. |
| Measure | Description | Time Frame |
|---|---|---|
| The Barthel Index | Assessment tool that measures a person's functional independence in activities of daily living and self-care. | 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 IpsiHandĀ® device use, or until completion of IpsiHandĀ® device use if occurring prior to 24 months. |
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Inclusion Criteria:
Exclusion Criteria:
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Chronic stroke patients (ā„ 6 months post-stroke) age 18 or older undergoing rehabilitation using the IpsiHandĀ® System.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lauren Souders, MOT, OTR/L, CBIS, CSRS | Contact | 213-286-3323 | innovation@kandu.com | |
| Seth Wilk, PhD | Contact | 213-286-3323 | innovation@kandu.com |
| Name | Affiliation | Role |
|---|---|---|
| Seth Wilk, PhD | Neurolutions, Inc. | Principal Investigator |
| Lee Fleisher, MD | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35702730 | Background | 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. | |
| 37693482 | Background | Rustamov 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. |
| Label | URL |
|---|---|
| FDA De Novo Authorization | View source |
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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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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Zarit Caregiver Burden Scale (ZBI) | Widely used questionnaire designed to assess the level of burden experienced by caregivers. | 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. | 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 IpsiHandĀ® device use, or until completion of IpsiHandĀ® 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 | 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. |
| 28550098 | Background | Bundy 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. |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |