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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 below
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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.
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I can use a wheelchair and have enough upper body control to use both hands.
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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.
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My nerves that control muscle movement are healthy.
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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.
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It's been over a year since my injury, and I haven't regained any function before the planned surgery.
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My spinal cord injury is between the C5 and C8 vertebrae.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~one year
This trial's timeline: 3 weeks for screening, Varies for treatment, and one year for reporting.

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

IST-12 (Implanted Stimulator and Sensor) Clinical Trial Eligibility Overview. Trial Name: NCT00583804 — N/A
Spinal Cord Injury Research Study Groups: Stimulation OFF, Stimulation ON
Spinal Cord Injury Clinical Trial 2023: IST-12 Highlights & Side Effects. Trial Name: NCT00583804 — N/A
IST-12 (Implanted Stimulator and Sensor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00583804 — N/A

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
Recent research and studies
~0 spots leftby Mar 2025