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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
Male or female
Intact vision
Timeline
Screening 3 weeks
Treatment Varies
Follow Up one year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 am either male or female.
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I can see clearly with both eyes.
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I can use a wheelchair and have enough upper body strength to use both hands.
Select...
I can use a wheelchair and have enough upper body control to use both hands.
Select...
I am positive and motivated with a supportive home.
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I don't have any stiff joints that could interfere with treatments.
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My spinal cord injury is between the C5 and C8 vertebrae.
Select...
My nerves that control muscle movement are healthy.
Select...
I will not have surgery until any current infections are treated.
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I am between 18 and 60 years old.
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My muscle stiffness is managed with medication.
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I am between 18 and 60 years old.
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It's been over a year since my injury without any improvement before surgery.
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I can move my shoulder, wrist, and hand normally.
Select...
It's been over a year since my injury, and I haven't regained any function before the planned surgery.
Select...
My spinal cord injury is between the C5 and C8 vertebrae.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ one year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
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 Test
Grasp-Release Test
Secondary outcome measures
Adverse Events
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
1,604 Previous Clinical Trials
3,305,561 Total Patients Enrolled
MetroHealth Medical CenterLead Sponsor
114 Previous Clinical Trials
21,453 Total Patients Enrolled
Case Western Reserve UniversityOTHER
298 Previous Clinical Trials
260,003 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am either male or female.I can see clearly with both eyes.I can use a wheelchair and have enough upper body strength to use both hands.I can use a wheelchair and have enough upper body control to use both hands.I am positive and motivated with a supportive home.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.I am between 18 and 60 years old.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.It's been over a year since my injury without any improvement before surgery.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.My spinal cord injury is between the C5 and C8 vertebrae.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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is recruitment for this experimentation still ongoing?
"The information posted on clinicaltrials.gov suggests that this medical experiment is not presently looking for participants, as it was last updated April 6th 2022. However, the directory does list over 900 other trials that are currently recruiting patients."
Answered by AI
Who else is applying?
What state do they live in?
Ohio
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
MetroHealth Medical Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
Always looking for a trial that can better my overall ability to regain mobility.
PatientReceived 1 prior treatment
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