Neuroprosthetic Device
Networked Neuroprosthetic System for Grasp and Trunk for Spinal Cord Injury
MetroHealth Medical Center, Cleveland, OH
Targeting 5 different conditionsNetworked Neuroprosthetic System for Grasp and TrunkN/ARecruitingResearch Sponsored by Kevin KilgoreEligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of cervical level spinal cord injury, either complete or incomplete; International Standards for Neurological Classification of Spinal Cord Injury (INCSCI) motor level of C4 through C8; American Spinal Injury Impairment Scale (AIS) grade A, B, C, or D; six months or more post-injury
Diagnosis of cervical level spinal cord injury, either complete or incomplete; International Standards for Neurological Classification of Spinal Cord Injury (INCSCI) motor level of C4 through C8; American Spinal Injury Impairment Scale (AIS) grade A, B, C, or D; six months or more post-injury
Must not have
Timeline
Screening 3 weeks
Treatment Varies
Follow upsthree months post-implant
Awards & highlights
No Placebo-Only Group
Study Summary
This trial is to test a new, fully implanted device that could help people with cervical spinal cord injuries regain hand function, reach, and trunk function. It is funded by the FDA, NIH, and NINDS.
Eligible Conditions
- Cervical Spinal Cord Injury
- Spinal Cord Injury Cervical (SCI-C)
- Spinal Cord Injury at C5-C7 Level With Incomplete Lesion
- C5-C7 Spinal Cord Injury with Complete Lesion
- Spinal Cord Injury
Eligibility Criteria
Inclusion Criteria
You will be eligible if you check “Yes” for the criteria belowSelect...
You have a spinal cord injury in your neck area that happened at least six months ago. The injury has affected your ability to move from the neck down and has been classified as severe.
Select...
You have a spinal cord injury in the neck area (between C4 and C8) that happened at least six months ago.
Select...
You have good strength and control in certain muscles in your arms, hands, and upper body, and in certain muscles in your legs and lower back.
Select...
You have strong muscle strength in specific muscles of your arm and trunk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow ups ~ pre-implant and three months post-implant
Screening ~ 3 weeks
Treatment ~ Varies
Follow ups ~ pre-implant and three months post-implant
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Activities of Daily Living Abilities Test
Secondary outcome measures
Grasp-Release Test
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Intervention - implant neuroprosthesisExperimental Treatment1 Intervention
Receives implanted networked neuroprosthetic system for hand, arm, and trunk function. Undergoes functional training and assessment.
Find a site
Who is running the clinical trial?
Case Western Reserve UniversityOTHER
286 Previous Clinical Trials
220,207 Total Patients Enrolled
Congressionally Directed Medical Research ProgramsFED
40 Previous Clinical Trials
6,423 Total Patients Enrolled
FDA Orphan Products DivisionUNKNOWN
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,297 Previous Clinical Trials
459,830 Total Patients Enrolled
Kevin KilgoreLead Sponsor
Media Library
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are applicants able to apply to this experiment currently?
"Affirmative. The clinical trial database indicates that this research program, which was first opened on December 1st 2014, is currently seeking participants. Around 10 individuals will be necessary to enrol at a single site."
Answered by AI
To what extent is this medical investigation being conducted by participants?
"Affirmative. The information hosted on clinicaltrials.gov confirms that this medical study, which was initially announced on December 1st 2014, is actively searching for participants. At present 10 patients are required from a single site."
Answered by AI
Who else is applying?
What state do they live in?
Pennsylvania
Louisiana
What site did they apply to?
MetroHealth Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
I’m motivated by my children and the desire to live. There is so much more I want to do in this lifetime and giving up isn’t an option. These are just a few reasons why I contacted you.
Patient
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