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Not yet recruiting NCT07147881

Prospective Real-World Evidence Study of the IpsiHand® System in Adult Stroke Survivors

— Observational Stroke Hemiparesis After Stroke Brain Computer Interface

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: IpsiHand.
Who it may be relevant to
Registry conditions: Stroke, Hemiparesis After Stroke, Brain Computer Interface. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device IpsiHand
    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.

Primary outcome measures

  • 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.]
Secondary outcome measures (4)
  • 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.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • Severe cognitive impairment that would impede utilization of IpsiHand®
  • Any contraindications to IpsiHand® device use
  • Inability to comprehend English

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

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. PMID 35702730
  • 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. PMID 37693482
  • 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. PMID 28550098

Identifiers

NCT: NCT07147881 · RWE_002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗