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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 below
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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 control to use both hands.
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My spinal cord injury is between the C5 and C8 vertebrae.
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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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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:
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I do not have uncontrolled seizures.
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I currently have an infection that has not gone away.
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I cannot tolerate pressure on my fingers due to sensitivity.
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I have a history of serious illness that could make surgery riskier.

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

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
1,664 Previous Clinical Trials
3,765,803 Total Patients Enrolled
MetroHealth Medical CenterLead Sponsor
118 Previous Clinical Trials
21,766 Total Patients Enrolled
Case Western Reserve UniversityOTHER
308 Previous Clinical Trials
250,703 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
~0 spots leftby Nov 2025
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