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Cognitive-based Prosthetics for Spinal Cord Injury
N/A
Waitlist Available
Led By Noam Y. Harel, MD PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up iimmediately after the procuedure
Awards & highlights
No Placebo-Only Group
Summary
This trial will test new technologies to help people with spinal cord injuries improve their hand grasp and reach through physical rehabilitation exercises.
Eligible Conditions
- Spinal Cord Injury
- Hand Weakness
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ iimmediately after the procuedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~iimmediately after the procuedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Time to achieve secure grasp upon initial contact
Time to complete pick-up and placement of object
Secondary study objectives
Error in placing object onto target
Motion pathlength in moving object
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Enhanced feedbackExperimental Treatment2 Interventions
Perform task with virtual reality and/or haptic feedback.
Group II: Intermediate feedback.Active Control2 Interventions
Perform task with intermediate feedback.
Group III: No cognitive feedbackActive Control2 Interventions
Perform task without cognitive feedback.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sensory brace
2021
N/A
~20
Cognition glove
2021
N/A
~20
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,658 Previous Clinical Trials
3,361,713 Total Patients Enrolled
Stevens Institute of TechnologyUNKNOWN
3 Previous Clinical Trials
8,539 Total Patients Enrolled
Noam Y. Harel, MD PhDPrincipal InvestigatorJames J. Peters Veterans Affairs Medical Center
2 Previous Clinical Trials
51 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a spinal cord injury between the neck and upper chest levels.You have weakness in your hands, scoring 2, 3, or 4 out of 5 on a muscle test for moving your fingers in different ways.You have had serious injuries to your brain or spinal cord in the past.You have had seizures in the past.You need a ventilator to help you breathe, or you have an open tracheostomy.You are taking medications that make seizures more likely to happen.You have had serious problems with memory or thinking.You have open sores on your face, neck, shoulders, arms, or hands.You had a spinal cord injury more than 12 months ago.
Research Study Groups:
This trial has the following groups:- Group 1: Intermediate feedback.
- Group 2: No cognitive feedback
- Group 3: Enhanced feedback
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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