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Implanted Stimulator and Sensor
IST-12 Implant for Spinal Cord Injury
N/A
Waitlist Available
Led By Kevin L Kilgore, Ph.D.
Research Sponsored by MetroHealth Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Intact vision
Functional in wheelchair with adequate trunk support to allow bimanual manipulation
Must not have
Uncontrolled disorders, i.e., seizures
Acute infection currently present that has not cleared
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a stimulator and sensor that is implanted in the spine to help people with cervical level spinal cord injuries regain function in their hands and arms.
Who is the study for?
This trial is for adults aged 18-60 with a spinal cord injury between C5-C8, who are at least one year post-injury without additional function recovery. Participants must have good vision, joint mobility in the upper extremity, controlled spasticity if applicable, and be able to use a wheelchair with trunk support. They should not have major chronic infections or illnesses that increase surgery risks.
What is being tested?
The study tests an implanted device called IST-12 designed to restore hand and arm functions in individuals with cervical level spinal cord injuries. The effectiveness of this stimulator and sensor will be evaluated through periodic testing in a laboratory setting.
What are the potential side effects?
While specific side effects are not listed, potential risks may include those commonly associated with surgical implantation such as infection risk at the surgery site, possible inflammation due to the device, discomfort or pain from the implant or its use.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can see clearly with both eyes.
Select...
I can use a wheelchair and have enough upper body control to use both hands.
Select...
My spinal cord injury is between the C5 and C8 vertebrae.
Select...
I will not have surgery until any current infections are treated.
Select...
I am between 18 and 60 years old.
Select...
It's been over a year since my injury, and I haven't regained any function before the planned surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have uncontrolled seizures.
Select...
I currently have an infection that has not gone away.
Select...
I cannot tolerate pressure on my fingers due to sensitivity.
Select...
I have a history of serious illness that could make surgery riskier.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Activities of Daily Living Test
Grasp-Release Test
Secondary study objectives
Adverse Events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Stimulation ONExperimental Treatment1 Intervention
Individuals implanted with stimulator/sensor device. Stimulator is turned on and is active.
Group II: Stimulation OFFActive Control1 Intervention
Function with stimulation turned off.
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentFED
1,668 Previous Clinical Trials
3,765,856 Total Patients Enrolled
MetroHealth Medical CenterLead Sponsor
120 Previous Clinical Trials
22,066 Total Patients Enrolled
Case Western Reserve UniversityOTHER
309 Previous Clinical Trials
251,249 Total Patients Enrolled
FDA Office of Orphan Products DevelopmentFED
72 Previous Clinical Trials
6,413 Total Patients Enrolled
Kevin L Kilgore, Ph.D.Principal InvestigatorMetroHealth Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can see clearly with both eyes.I can use a wheelchair and have enough upper body control to use both hands.I don't have any stiff joints that could interfere with treatments.My spinal cord injury is between the C5 and C8 vertebrae.I do not have uncontrolled seizures.I am positive and motivated with a supportive home.I do not have immune, heart rhythm problems, undiagnosed breast lumps, skin conditions, or major organ failure.My nerves that control muscle movement are healthy.I will not have surgery until any current infections are treated.My muscle stiffness is managed with medication.I am either male or female.I am between 18 and 60 years old.I currently have an infection that has not gone away.I cannot tolerate pressure on my fingers due to sensitivity.I can move my shoulder, wrist, and hand normally.It's been over a year since my injury, and I haven't regained any function before the planned surgery.I have a history of serious illness that could make surgery riskier.You are visually impaired.
Research Study Groups:
This trial has the following groups:- Group 1: Stimulation OFF
- Group 2: Stimulation ON
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.