StrokeNCT04123808
IpsiHand System for Rehabilitation of the Arm and Hand After Stroke
A study testing IpsiHand Treatment in people with Stroke and Hemiparesis, run by Columbia University.
Trial summary
This study aims to assess whether the NeuroLutions Upper Extremity Rehabilitation System (known as IpsiHand) will help stroke patients regain strength and functional movements in their arm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Hemiparesis
- What is being tested?
- IpsiHand Treatment
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 2 Dec 2019to 30 Jun 2020
- 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
- Diagnosis of stroke(s), with most recent stroke at least 6 months prior to study start (can be ischemic or hemorrhagic)
- PROM: Full extension of digits 2 and 3 at MPs, PIPs, and DIPs
- English speaking
- Intact cognition to provide informed consent
- Intact language skills to comprehend and follow directions
- Experiencing difficulty performing ADLs with affected upper limb
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- Upper extremity Botox allowable, but not required
- Botox users must continue regimen at regular intervals for duration of study
- Botox users will provide clinic note for each injection (date, dose, and muscle location)
- Botox + Study Schedule
- At study initiation, Botox injection will occur between 3-7 days prior to baseline measurement and initiation of device use
- Repeat Botox injections must be completed at least 3 days prior to any administration of the outcome measures
Who cannot join
- Concurrent participation in another study
- Co-morbid orthopedic condition/pain limiting functional use of the impaired upper limb
- History of neurological disorder other than stroke
- Botox user unable to comply with above noted requirements
- Ongoing physical or occupational therapy addressing the upper limb
- Ongoing electric stimulation or other rehabilitative devices (e.g. robotics, virtual reality) to upper limb
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- Cognitive impairment: Short Blessed Test Score 9
- Significant spasticity: Modified Ashworth Scale score 3 at the elbow
- Significant hemispatial neglect: Mesulam Cancellation Test 3 unilaterally
- Insufficient Strength: Motricity Index score for shoulder abduction 18
- Significantly impaired sensation of impaired upper limb: National Institutes of Health Stroke Scale - Item 8 (Sensory) score of 2
- History of cranioplasty
- History of seizure disorder
- No changes to usual exercises, splint use, or oral baclofen/anti-spasticity medication use during trial
About this study
Official title: Dosing Effects of an Upper Extremity Rehabilitation Program Using a Brain-Computer Interface Mediated Robotic Hand Orthosis for Chronic Stroke Patients: IpsiHand System
This study aims to assess whether the NeuroLutions Upper Extremity Rehabilitation System (known as IpsiHand) will help stroke patients regain strength and functional movements in their arm. The IpsiHand system involves using a hand robotic device that is controlled by brain waves, known as a Brain-Computer Interface (BCI). By using the device, participants will be harnessing brainwaves from the side of their brain not affected by stroke to control the robotic device on the hand that is weaker from the stroke.
Read the detailed description
This trial aims to assess the effectiveness of the NeuroLutions Upper Extremity Rehabilitation System, known as IpsiHand, on functional motor recovery and neuroplasticity for chronic stroke survivors with hemiparesis (N=27). The IpsiHand system involves a Brain-Computer Interface (BCI) as a control for a robotic hand orthosis. Participants will complete 16-32 weeks of home therapy with the IpsiHand system.
- Conditions
- Stroke, Hemiparesis
- Being tested
- IpsiHand Treatment
- Keywords
- Stroke, Hemiparesis, Rehabilitation, Upper Extremity, Neurological Rehabilitation, Neuronal Plasticity, Brain-Computer Interfaces, Robotics
- Medical subject headings
- Stroke, Paresis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IpsiHand TreatmentDevice
The IpsiHand system utilizes a Brain-Computer Interface (BCI) as a control for a robotic hand orthosis donned on the affected upper extremity as participants are guided through a rehabilitation program on a tablet. Participants will complete 16-32 weeks of home therapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline, at 4-week intervals, and 3 months post no-device use, to track progress.
| Study group | Role | What they receive |
|---|---|---|
| IpsiHand Treatment | Experimental | All participants will receive treatment with IpsiHand device Receives: Device: IpsiHand Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fugl-Meyer Assessment of Motor Recovery after Stroke for Upper Extremity
The Fugl-Meyer is a scale that measures capacity of the arm. There are 33 items that evaluate reflexes, active movement, grasp patterns, speed, and coordination of the arm and hand. Each item is scored from 0-2, with a maximum total score of 66. Higher scores indicate better performance.
Measured: Baseline through 3 months post no device use
Secondary outcomes (2)
Action Research Arm Test
The ARAT is a scale that measures activity participation of the arm. There are 19 items that several types of grasps, grips, pinches, and gross movements of the arm and hand. Each item is scored from 0-3, with a maximum total score of 57. Higher scores indicate better performance.
Measured: Baseline through 3 months post no device use
Box and Block Test
The Box and Block Test measures the number of blocks a participant can pick up and place over a patrician in 1 minute. The number of blocks successfully moved are counted and a higher number indicates better performance.
Measured: Baseline through 3 months post no device use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2019
- Study start2 Dec 2019
- Primary completion30 Jun 2020
- Study completion30 Jun 2020
Why it stopped: Closed by sponsor
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.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Neurolutions, Inc.
- Responsible party
- Principal investigator, Joel Stein, MD, Columbia University
- Investigators
- Joel Stein, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123808
- Sponsor's protocol ID
- AAAS4076
- Status last verified
- Aug 2020
- First submitted
- 10 Oct 2019
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 28550098Cervera 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.
PubMed 29761128Zeiler 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.
PubMed 24136129
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dosing Effects of an Upper Extremity Rehabilitation Program Using a Brain-Computer Interface Mediated Robotic Hand Orthosis for Chronic Stroke Patients: IpsiHand System
- ClinicalTrials.gov ID
- NCT04123808
- Acronym / sponsor ID
- AAAS4076
- Conditions
- Stroke, Hemiparesis
- Keywords
- Stroke, Hemiparesis, Rehabilitation, Upper Extremity, Neurological Rehabilitation, Neuronal Plasticity, Brain-Computer Interfaces, Robotics
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Closed by sponsor
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Neurolutions, Inc.
- Study start
- 2 Dec 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 11 Oct 2019 (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 aims to assess whether the NeuroLutions Upper Extremity Rehabilitation System (known as IpsiHand) will help stroke patients regain strength and functional movements in their arm. The IpsiHand system involves using a hand robotic device that is controlled by brain waves, known as a Brain-Computer Interface (BCI). By using the device, participants will be harnessing brainwaves from the side of their brain not affected by stroke to control the robotic device on the hand that is weaker from the stroke.
Detailed description
This trial aims to assess the effectiveness of the NeuroLutions Upper Extremity Rehabilitation System, known as IpsiHand, on functional motor recovery and neuroplasticity for chronic stroke survivors with hemiparesis (N=27). The IpsiHand system involves a Brain-Computer Interface (BCI) as a control for a robotic hand orthosis. Participants will complete 16-32 weeks of home therapy with the IpsiHand system.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IpsiHand Treatment | Experimental | Device: IpsiHand TreatmentAll participants will receive treatment with IpsiHand device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Diagnosis of stroke(s), with most recent stroke at least 6 months prior to study start (can be ischemic or hemorrhagic)
- PROM: Full extension of digits 2 and 3 at MPs, PIPs, and DIPs
- English speaking
- Intact cognition to provide informed consent
- Intact language skills to comprehend and follow directions
Key exclusion criteria (14 listed)
- Concurrent participation in another study
- Co-morbid orthopedic condition/pain limiting functional use of the impaired upper limb
- History of neurological disorder other than stroke
- Botox user unable to comply with above noted requirements
- Ongoing physical or occupational therapy addressing the upper limb
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 |
|---|---|---|
| IpsiHand TreatmentThe IpsiHand system utilizes a Brain-Computer Interface (BCI) as a control for a robotic hand orthosis donned on the affected upper extremity as participants are guided through a rehabilitation program on a tablet. Participants will complete 16-32 weeks of home therapy with the IpsiHand system. Motor function of their impaired upper extremity will be evaluated at baseline, at 4-week intervals, and 3 months post no-device use, to track progress. | Device | IpsiHand Treatment |
Primary outcome
Fugl-Meyer Assessment of Motor Recovery after Stroke for Upper Extremity
Time frame: Baseline through 3 months post no device use
The Fugl-Meyer is a scale that measures capacity of the arm. There are 33 items that evaluate reflexes, active movement, grasp patterns, speed, and coordination of the arm and hand. Each item is scored from 0-2, with a maximum total score of 66. Higher scores indicate better performance.
2 secondary outcomes
Action Research Arm Test
Time frame: Baseline through 3 months post no device use
Box and Block Test
Time frame: Baseline through 3 months post no device use
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- 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.
- Background: PubMed 29761128Cervera 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.
- Background: PubMed 24136129Zeiler 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.
- Individual participant dataSharing planned: No
Related trials for Stroke
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ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
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Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
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Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
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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.
Joel Stein, MD principal investigator
Columbia University
Questions about this trial
What is this clinical trial studying?
A study testing IpsiHand Treatment in people with Stroke and Hemiparesis, run by Columbia University.
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 12 inclusion and 14 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: withdrawn, as of the sponsor's last update on 5 Aug 2020. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Fugl-Meyer Assessment of Motor Recovery after Stroke for Upper Extremity (time frame: Baseline through 3 months post no device use). 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 NCT04123808, 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 5 Aug 2020.