Spinal Cord Injury Clinical Trial
Official title:
Acute Electrocorticography (ECoG) Direct Brain Interface for Individuals With Upper Limb Paralysis
Verified date | July 2016 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 3 |
Est. completion date | April 2015 |
Est. primary completion date | April 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The primary outcome is the successful control of a variety of external devices using neural data recorded with ECoG. | Participants will attempt to control devices such as computer cursors, virtual reality environments and assistive devices such as hand orthoses or surface functional electrical stimulators using their brain activity recorded through ECoG. | Up to 29 days of device implantation | No |
Secondary | A secondary outcome is to demonstrate that individuals with upper limb paralysis can successfully achieve direct brain control of assistive devices using an electrocorticography (ECoG)-based brain-computer interface system. | Participants will be asked to perform, attempt, or imagine performing motor tasks while their brain activity is recorded in order to observe the changes in neural activity during each task. | Up to 29 days of device implantation | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT02574572 -
Autologous Mesenchymal Stem Cells Transplantation in Cervical Chronic and Complete Spinal Cord Injury
|
Phase 1 | |
Recruiting |
NCT05941819 -
ARC Therapy to Restore Hemodynamic Stability and Trunk Control in People With Spinal Cord Injury
|
N/A | |
Completed |
NCT05265377 -
Safety and Usability of the STELO Exoskeleton in People With Acquired Brain Injury and Spinal Cord Injury
|
N/A | |
Recruiting |
NCT02331979 -
Improving Bladder Function in SCI by Neuromodulation
|
N/A | |
Completed |
NCT02777281 -
Safe and Effective Shoulder Exercise Training in Manual Wheelchair Users With SCI
|
N/A | |
Recruiting |
NCT02978638 -
Electrical Stimulation for Continence After Spinal Cord Injury
|
N/A | |
Withdrawn |
NCT02237547 -
Safety and Feasibility Study of Cell Therapy in Treatment of Spinal Cord Injury
|
Phase 1/Phase 2 | |
Completed |
NCT02262234 -
Education Interventions for Self-Management of Pain Post-SCI: A Pilot Study
|
Phase 1/Phase 2 | |
Completed |
NCT02161913 -
Comparison of Two Psycho-educational Family Group Interventions for Persons With SCI and Their Caregivers
|
N/A | |
Completed |
NCT01884662 -
Virtual Walking for Neuropathic Pain in Spinal Cord Injury
|
N/A | |
Completed |
NCT01642901 -
Zoledronic Acid in Acute Spinal Cord Injury
|
Phase 3 | |
Terminated |
NCT02080039 -
Electrical Stimulation of Denervated Muscles After Spinal Cord Injury
|
N/A | |
Terminated |
NCT01433159 -
Comparison of HP011-101 to Standard Care for Stage I-II Pressure Ulcers in Subjects With Spinal Cord Injury
|
Phase 2 | |
Completed |
NCT01471613 -
Lithium, Cord Blood Cells and the Combination in the Treatment of Acute & Sub-acute Spinal Cord Injury
|
Phase 1/Phase 2 | |
Completed |
NCT01467817 -
Obesity/Overweight in Persons With Early and Chronic Spinal Cord Injury (SCI)
|
N/A | |
Completed |
NCT02149511 -
Longitudinal Morphometric Changes Following SCI
|
||
Completed |
NCT00663663 -
Telephone Intervention for Pain Study (TIPS)
|
N/A | |
Completed |
NCT01086930 -
Early Intensive Hand Rehabilitation After Spinal Cord Injury
|
Phase 3 | |
Completed |
NCT01025609 -
Dietary Patterns and Cardiovascular (CVD) Risk in Spinal Cord Injury (SCI) Factors In Individuals With Chronic Spinal Cord Injury
|
||
Terminated |
NCT01005615 -
Patterned Functional Electrical Stimulation (FES) Ergometry of Arm and Shoulder in Individuals With Spinal Cord Injury
|
Phase 1/Phase 2 |