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Neuroprosthetic Device
Neuroprosthesis Device for Spinal Cord Injury (GRANND Trial)
N/A
Recruiting
Led By Anne Bryden, PhD, OTR/L
Research Sponsored by MetroHealth Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-implant and three months post-implant, 6 months post implant, 12 months post implant
Awards & highlights
GRANND Trial Summary
This trial will test a device to help people with spinal cord injuries use their arms and hands better.
Who is the study for?
This trial is for individuals over 16 years old with a stable cervical spinal cord injury (SCI) at levels C1-C7 and AIS grades A, B, or C. They must have certain upper extremity muscle strength and be medically stable. Excluded are those with other neurological conditions, active infections, pregnancy, co-existing cervical spine issues, or involvement in conflicting studies.Check my eligibility
What is being tested?
The Networked Neuroprosthesis Device - Upper Extremity (NP-UE) is being tested for safety and effectiveness in helping people with cervical SCI to regain grasp-release functions of their hands.See study design
What are the potential side effects?
While specific side effects aren't listed here, potential risks may include device-related complications like infection or discomfort at the implant site, unintended nerve stimulation effects, and possible interference with other medical devices.
GRANND Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-implant and three months post-implant, 6 months post implant, 12 months post implant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-implant and three months post-implant, 6 months post implant, 12 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
Change in Grasp-Release Test
Secondary outcome measures
Change in Activities of Daily Living (ADL) Abilities Test
Change in Canadian Occupational Performance Measure (COPM)
Change in Grasp Dynameter(force)
+1 moreGRANND Trial Design
1Treatment groups
Experimental Treatment
Group I: Experimental: Intervention - implant neuroprosthesisExperimental Treatment1 Intervention
Receives implanted networked neuroprosthetic system for arm and hand function. Undergoes functional training and assessment.
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Who is running the clinical trial?
MetroHealth Medical CenterLead Sponsor
114 Previous Clinical Trials
21,376 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,341 Previous Clinical Trials
649,576 Total Patients Enrolled
Case Western Reserve UniversityOTHER
299 Previous Clinical Trials
246,569 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of blood clotting disorders, HIV, heart/lung disease, slow heart rate, uncontrolled nerve system reactions, or COPD.My spinal cord injury is in my neck and is classified as severe to moderate.I have a neurological condition like MS or diabetes affecting my nerves.I do not have any untreated infections like skin sores, UTIs, or pneumonia.I had nerve surgery on my arm and have been stable for over a year.I have a spinal condition alongside my main diagnosis.My health condition is currently stable.I have a broken arm that I cannot use because it hasn't healed.I am older than 16 years.It has been over 6 months since my injury.My arm muscles are strong enough to move against some resistance.I have good arm strength where my device will be implanted.I understand the study and can give my consent.I do not have any health conditions that could affect my safety or participation in the study.I have been stable for 6 months after surgery on my arm's tendons.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Intervention - implant neuroprosthesis
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there availability for participants to join this research?
"Affirmative. Records hosted on clinicaltrials.gov indicate that this research is currently recruiting subjects; it was first declared in February 23rd 2022 and most recently amended in May 8th 2023, with a goal of collecting data from 13 participants at one location."
Answered by AI
What is the current participant count of this trial?
"Affirmative. Per data on clinicaltrials.gov, this medical study is presently recruiting participants and was initially published on February 23rd 2022. The most recent update to the trial's information occurred May 8th 2023, seeking 13 patients at a single site."
Answered by AI
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