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NCT03611855 · ClinicalTrials.gov registry record · NA
Chronic Stroke Rehabilitation With Contralesional Brain-Computer Interface
A NA study, sponsored by Washington University School of Medicine.
- Terminated
- Registry status
- NA
- Development phase
- 56
- Enrollment target
NCT03611855 is a NA study that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 56 participants.
The verdict
NCT03611855, a NA study, was terminated before completion, sponsored by Washington University School of Medicine.
- TERMINATED
- Registry status
- NA
- Development phase
- 56 participants
- Enrollment target
Study Summary
The purpose of this research study is to show that a computer can analyze brain waves and that those brain waves can be used to control an external device. This study will also show whether passive movement of the affected hand as a result of brain-based control can cause rehabilitation from the effects of a stroke. Additionally, this study will show how rehabilitation with a brain-controlled device may affect the function and organization of the brain. Stroke is the most common neurological disorder in the US with 795,000 strokes per year (Lloyd-Jones et al. 2009). Of survivors, 15-30% are permanently disabled and 20% require institutional care (Mackay et al. 2004; Lloyd-Jones et al. 2009). In survivors over age 65, 50% had hemiparesis, 30% were unable to walk without assistance, and 26% received institutional care six months post stroke (Lloyd-Jones et al. 2009). These deficits are significant, as recovery is completed after three months (Duncan et al. 1992; Jorgensen et al. 1995). This large patient population with decreased quality of life fuels the need to develop novel methods for improving functional rehabilitation. We propose that signals from the unaffected hemisphere can be used to develop a novel Brain-Computer interface (BCI) system that can facilitate functional improvement or recovery. This can be accomplished by using signals recorded from the brain as a control signal for a robotic hand orthotic to improve motor function, or by strengthening functional pathways through neural plasticity. Neural activity from the unaffected hemisphere to the affected hemiparetic limb would provide a BCI control in stroke survivors lesions that prevent perilesional mechanisms of motor recovery. The development of BCI systems for functional recovery in the affected limb in stroke survivors will be significant because they will provide a path for improving quality of life for chronic stroke survivors who would otherwise have permanent loss of function. Initially, the st
Interventions
- DEVICE BCI Rehabilitation
- OTHER Range of Motion Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2018-04-26 |
| Est. Completion | 2020-03-18 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03611855
The ClinicalTrials.gov registry entry for NCT03611855 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 56 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which BCI Rehabilitation is the first listed.
NCT03611855 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03611855 about?
NCT03611855 is a clinical study titled "Chronic Stroke Rehabilitation With Contralesional Brain-Computer Interface". The purpose of this research study is to show that a computer can analyze brain waves and that those brain waves can be used to control an external device. This study will also show whether passive movement of the affected hand as a result of brain-based control can cause rehabilitation from the eff...
What is the current status of trial NCT03611855?
This trial is currently terminated. It is a NA study. The enrollment target is 56 participants. The study started on 2018-04-26. Estimated completion is 2020-03-18.
What interventions are being tested in trial NCT03611855?
The interventions under investigation include: BCI Rehabilitation (DEVICE), Range of Motion Therapy (OTHER).
Who is sponsoring clinical trial NCT03611855?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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