N/A
N=6
ECoG Direct Brain Interface for Individuals With Upper Limb Paralysis
Tetraplegia · Spinal Cord Injury · Brachial Plexus Injury · Muscular Dystrophy · ALS
Bottom Line
View on ClinicalTrials.gov: NCT01393444 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG — 3 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Implantation of ECoG sensors on the brain surface (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pittsburgh
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Able to Successfully Control of a Variety of External Devices Using Neural Data Recorded With ECoG |
3 | — |
| SECONDARY Number of Participants Able to Achieve Direct Brain Control of Assistive Devices Using an Electrocorticography (ECoG)-Based Brain-computer Interface System |
3 | — |
Summary
The purpose of this research study is to demonstrate that individuals with upper limb paralysis due to spinal cord injury, brachial plexus injury, amyotrophic lateral sclerosis and brain stem stroke can successfully achieve direct brain control of assistive devices using an electrocorticography (ECoG)-based brain computer interface system.
Eligibility Criteria
Inclusion Criteria
- Limited or no ability to use both hands due to cervical spinal cord injury, brachial plexus injury, brainstem stroke, muscular dystrophy, or amyotrophic lateral sclerosis (ALS) or other motor neuron diseases
- At least 1 year post-injury
- Live within 1 hour of the University of Pittsburgh or willing to stay in Pittsburgh while the ECoG electrode is implanted (up to 29 days)
- Additional inclusion criteria must also be reviewed
Exclusion Criteria
- Certain implanted devices
- Presence of other serious disease or disorder that could affect ability to participate in this study
- Additional exclusion criteria must also be reviewed
Data sourced from ClinicalTrials.gov (NCT01393444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.