Your session is about to expire
← Back to Search
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.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Spinal Cord Injury (SCI) involving electrical stimulation or neural interface technology, such as the Networked Neuroprosthesis Device - Upper Extremity, work by delivering electrical currents to stimulate nerves and muscles. This stimulation can help restore motor function and improve muscle strength by activating neural pathways that may have been damaged or are underutilized due to the injury.
These treatments are crucial for SCI patients as they can enhance mobility, reduce muscle atrophy, and improve overall quality of life by enabling greater independence and functionality.
The effect of neural mobilisation on cervico-brachial pain: design of a randomised controlled trial.Neuromodulation of the cervical spinal cord in the treatment of chronic intractable neck and upper extremity pain: a case series and review of the literature.
The effect of neural mobilisation on cervico-brachial pain: design of a randomised controlled trial.Neuromodulation of the cervical spinal cord in the treatment of chronic intractable neck and upper extremity pain: a case series and review of the literature.
Find a Location
Who is running the clinical trial?
MetroHealth Medical CenterLead Sponsor
115 Previous Clinical Trials
21,626 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,347 Previous Clinical Trials
651,001 Total Patients Enrolled
Case Western Reserve UniversityOTHER
300 Previous Clinical Trials
246,609 Total Patients Enrolled
Media Library
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.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger