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This study aims to evaluate the impact of the Neurolutions Upper Extremity Rehabilitation System, known as IpsiHand, on improving functional motor control for post-stroke patients with hemiparesis. The Neurolutions System is a brain-computer interface (BCI) comprised of a robotic orthosis, worn on the hand and wrist, and operated by the patient's brain waves which are measured by EEG electrodes. The system also utilizes a tablet interface to provide therapy instructions to the patient.
Participants will complete 12 weeks of home therapy with the Neurolutions IpsiHand System. Outcomes will be based on a comparison of the patient's baseline measurements to post-therapy assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IpsiHand Device | Experimental | All participants will receive treatment with the IpsiHand Device. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IpsiHand Therapy | Device | The IpsiHand system utilizes a Brain-Computer Interface (BCI) to enable operation of a robotic hand exoskeleton worn on the hand and wrist as participants are guided through a rehabilitation program on a tablet. Participants will complete 12 weeks of hometherapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline, at 4-week intervals, and 12 weeks completion of IpsiHand use. |
| Measure | Description | Time Frame |
|---|---|---|
| Fugl-Meyer Assessment - Upper Extremity | The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The FMA is a score on a scale of 0 to 66 points. A lower score indicates impaired motor function in the upper extremity assessed. A higher score on the scale indicates better motor function of the upper extremity. A score of 66 would indicate there is no motor function impairment of the upper extremity. | "Fugl-Meyer Assessment - Upper Extremity" average change in points from the baseline average score and 12-week average score. |
| Measure | Description | Time Frame |
|---|---|---|
| Arm Motor Ability Test Change Points on Scale From Baseline to 12 Weeks | The Arm Motor Ability Test (AMAT is used to measure functional limitation in the upper extremity in rehabilitative trials enrolling individuals with stroke primarily. The measure requires clients to perform 28 common unilateral and bilateral UE tasks. Performance on each task is timed by the evaluator and rated by the evaluator using a 6-point Functional Ability Scale from 0 to 5. A score of 0 indicates no attempt moving the affected upper extremity in the task. A score of 5 indicates one is using their affected arm with full movement, normal. One can achieve a total a range of 0 points to 140 points |
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Inclusion Criteria:
Exclusion Criteria -
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| Name | Affiliation | Role |
|---|---|---|
| Alexandre Carter, MD, PhD | Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurolutions | Santa Cruz | California | 95060 | United States | ||
| Neurolutions |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 29761128 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | IpsiHand Intervention | This study was a prospective, non-randomized, self-controlled study performed in two phases at two investigational sites. 17 chronic stroke survivors (6 months or more post stroke) utilized the BCI Neurolutions IpsiHand System (the "device") at home for 12 weeks. During this time, data was collected at baseline, during, and upon completion of use of the Neurolutions IpsiHand System. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | IpsiHand Intervention | This study was a prospective, non-randomized, self-controlled study performed in two phases at two investigational sites. 17 chronic stroke survivors (6 months or more post stroke) utilized the BCI Neurolutions IpsiHand System (the "device") at home for 12 weeks. During this time, data was collected at baseline, during, and upon completion of use of the Neurolutions IpsiHand System. IpsiHand is a device which includes a robotic exoskeleton that you wear on your forearm and hand, an EEG headset worn on your head, and a tablet which includes therapy software and guides you through daily therapy exercises. Once a participant completes an initial EEG screening, the participant completes a set of baseline measurements, the IpsiHand BCI device is then provided to the participants and are to be used a minimum of 5 days a week out of 7 days , for a total duration of 12 weeks. Participants are seen monthly throughout the 12-week duration while they are using the IpsiHand. After completion of device use, participants were asked to be evaluated 6 months after discontinuation of the IpsiHand to assess durability effects. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Fugl-Meyer Assessment - Upper Extremity | The Fugl-Meyer Assessment (FMA) is a stroke-specific, performance-based impairment index. It is designed to assess motor functioning and joint functioning in patients with post-stroke hemiplegia. It is applied clinically and in research to determine disease severity, describe motor recovery, and to plan and assess treatment. The FMA is a score on a scale of 0 to 66 points. A lower score indicates impaired motor function in the upper extremity assessed. A higher score on the scale indicates better motor function of the upper extremity. A score of 66 would indicate there is no motor function impairment of the upper extremity. | Posted | Mean | Standard Deviation | Units on a scale | "Fugl-Meyer Assessment - Upper Extremity" average change in points from the baseline average score and 12-week average score. |
|
All adverse events were monitored throughout the study completion, an average of 2 years.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | IpsiHand Intervention | This study was a prospective, non-randomized, self-controlled study performed in two phases at two investigational sites. 17 chronic stroke survivors (6 months or more post stroke) utilized the BCI Neurolutions IpsiHand System (the "device") at home for 12 weeks. During this time, data was collected at baseline, during, and upon completion of use of the Neurolutions IpsiHand System. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Innovation | Neurolutions | 6027033730 | innovation@kandu.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 20, 2020 | Nov 17, 2021 | Prot_SAP_001.pdf |
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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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| Change in AMAT score (points) from Baseline to 12 Weeks |
| St Louis |
| Missouri |
| 63110 |
| United States |
| Cervera MA, Soekadar SR, Ushiba J, Millan JDR, Liu M, Birbaumer N, Garipelli G. Brain-computer interfaces for post-stroke motor rehabilitation: a meta-analysis. Ann Clin Transl Neurol. 2018 Mar 25;5(5):651-663. doi: 10.1002/acn3.544. eCollection 2018 May. |
| 24136129 | Background | Zeiler SR, Krakauer JW. The interaction between training and plasticity in the poststroke brain. Curr Opin Neurol. 2013 Dec;26(6):609-16. doi: 10.1097/WCO.0000000000000025. |
| 39345118 | Derived | Rustamov N, Souders L, Sheehan L, Carter A, Leuthardt EC. IpsiHand Brain-Computer Interface Therapy Induces Broad Upper Extremity Motor Rehabilitation in Chronic Stroke. Neurorehabil Neural Repair. 2025 Jan;39(1):74-86. doi: 10.1177/15459683241287731. Epub 2024 Sep 30. |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline Scores of the "Fugl Meyer Assessment of the Upper Extremity" Score | Mean average score on the "Fugl-Meyer Assessment of the Upper Extremity" assessment. This assessment has a total score on a scale range of 0 to 66 points. The lower the score, the lower motor function of the impaired upper extremity. The higher the score, the better motor function in the upper extremity. A score of 66 would indicate no motor impairments assessed in the upper extremity. | Mean | Standard Deviation | Units on a scale |
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| Secondary | Arm Motor Ability Test Change Points on Scale From Baseline to 12 Weeks | The Arm Motor Ability Test (AMAT is used to measure functional limitation in the upper extremity in rehabilitative trials enrolling individuals with stroke primarily. The measure requires clients to perform 28 common unilateral and bilateral UE tasks. Performance on each task is timed by the evaluator and rated by the evaluator using a 6-point Functional Ability Scale from 0 to 5. A score of 0 indicates no attempt moving the affected upper extremity in the task. A score of 5 indicates one is using their affected arm with full movement, normal. One can achieve a total a range of 0 points to 140 points | Posted | Mean | Standard Deviation | units on a scale | Change in AMAT score (points) from Baseline to 12 Weeks |
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| 0 |
| 17 |
| 0 |
| 17 |
| 0 |
| 17 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |