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Neurostimulation Device
Spinal Cord Stimulation for Lower Extremity Amputation (SCS-90 Trial)
N/A
Recruiting
Led By Lee E Fisher, PhD
Research Sponsored by Lee Fisher, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Subjects must be between the ages of 22 and 70 years old. Participants outside this age range may be at an increased medical risk and have an increased risk of fatigue during testing.
Subjects must have used their current prosthesis for at least 6 months and achieved at least K-1 ambulator status at the time of lead placement, as determined by the Amputee Mobility Predictor.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
SCS-90 Trial Summary
This trial is looking at whether electrical stimulation of the lumbar spinal cord and spinal nerves can provide sensory information to amputees and reduce phantom limb pain.
Who is the study for?
This trial is for lower-limb amputees aged 22-70 who are at least six months post-amputation, have been using their current prosthesis for over six months, and can walk with or without support. Pregnant women, those on blood thinners, with severe diseases, allergies to MRI contrast agents or renal failure, high hemoglobin A1c levels (>8.0 mg/dl), implanted devices not cleared for MRI (like pacemakers), immunosuppressed individuals or those in radiation-heavy professions cannot join.Check my eligibility
What is being tested?
The study tests a spinal cord stimulator designed to provide sensory feedback and reduce phantom limb pain in lower-limb amputees. It aims to understand how electrical stimulation of the spinal nerves affects sensation quality and prosthetic control while also measuring its impact on phantom limb perception and associated pain.See study design
What are the potential side effects?
Potential side effects may include discomfort from electrical stimulation, skin irritation where the device attaches, possible nerve injury during lead placement for the stimulator, and typical risks associated with MRIs if applicable.
SCS-90 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 22 and 70 years old.
Select...
I've used my current prosthesis for 6+ months and can walk with it.
SCS-90 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Location of evoked sensory percepts
Number of participants experiencing serious device-related adverse events up to 90 days following implantation
Stimulation neurophysiology thresholds to a variety of stimulus parameters
+1 moreSecondary outcome measures
Limb structure
Change in phantom limb pain using the McGill Pain Questionnaire
Qualitative self-report of evoked sensations
SCS-90 Trial Design
1Treatment groups
Experimental Treatment
Group I: Spinal cord stimulationExperimental Treatment1 Intervention
Spinal cord stimulator leads (2-3 leads) will be placed in the lumbar epidural space of lower limb amputees to determine if the patient experiences any pain reduction from spinal cord stimulation.
Participants in this study receive spinal cord stimulation will be trans-tibial amputees that are at least six month post--amputation. Subjects will have varying levels of phantom limb sensation and pain, but should have no other significant neurological disorders.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spinal cord stimulator
2017
N/A
~50
Find a Location
Who is running the clinical trial?
Lee Fisher, PhDLead Sponsor
3 Previous Clinical Trials
55 Total Patients Enrolled
National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,340 Previous Clinical Trials
649,354 Total Patients Enrolled
Lee E Fisher, PhDPrincipal InvestigatorUniversity of Pittsburgh
1 Previous Clinical Trials
10 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 22 and 70 years old.You have a high score on a questionnaire about your mental health and have been told by the study doctor and psychologist that you are not suitable for the study.Your hemoglobin A1c level cannot be higher than 8.0 mg/dl when you get the implant.I am not taking any blood-thinning medications.I've used my current prosthesis for 6+ months and can walk with it.It has been over 6 months since my amputation.I haven't been exposed to extra radiation due to my job or medical condition in the last year.I am not on any medications that weaken my immune system.I am not currently undergoing diathermy therapy.I am not pregnant or breastfeeding.I don't have allergies to MRI dyes or severe kidney problems.I have had one lower limb amputated between my ankle and knee.
Research Study Groups:
This trial has the following groups:- Group 1: Spinal cord stimulation
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 enrollment still open for this investigation?
"The clinical trial website reports that this research is still recruiting. The study was first put up on December 16th 2016 and the details were last modified on January 5th 2022."
Answered by AI
Can individuals aged 85 and over take part in this clinical investigation?
"The accepted patients for this clinical trial are between 22 to 70 years old. In addition, there is one study group comprised of individuals below 18 and another containing seniors over 65."
Answered by AI
Do I fulfill the requirements to be recruited for this scientific experiment?
"Currently, this trial seeks 10 patients who have experienced an amputation between their ankle and knee joint. To be eligible for the study, applicants must be aged between 22-70 years old and 6 months post-amputation at lead placement time. Smaller amputations on the opposite side of the body (i.e toes or partial foot) are not a disqualification factor but those outside the given age range may experience increased medical risk coupled with fatigue during testing sessions."
Answered by AI
How many subjects are currently enrolled in this trial?
"Indeed, clinicaltrials.gov states that this trial is recruiting participants and has been doing so since December 16th 2016. The most recent update was on January 5th 2022 and the goal is to find 10 people willing to participate at 1 site."
Answered by AI
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