Spinal cord stimulation system for Amputation

University of Pittsburgh, Pittsburgh, PA

Targeting 2 different conditionsSpinal cord stimulation systemN/ARecruitingResearch Sponsored by Lee Fisher, PhD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upup to 2 days

Awards & highlights

No Placebo-Only Group

Study Summary

This trial is testing whether electrical stimulation of the spinal cord can help control pain. Investigators will ask subjects to report the types of sensations felt and perform detailed psychophysical metrics to examine participants' ability to discriminate sensations.

Eligible Conditions

Amputation
Phantom Sensation

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 days for reporting.

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

Stimulation neurophysiology thresholds to stimulus parameters

Stimulation perceptual thresholds to stimulus parameters

Secondary outcome measures

Qualitative self-report of evoked sensations

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Stimulation in individuals with implanted stimulation systemsExperimental Treatment1 Intervention

During psychophysical stimulation trials, an external stimulator will be connected to the SCS lead, a volley of stimulation will be performed, and the subject will be asked to respond to standard psychophysical questions, as well as to provide any additional comments.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Spinal cord stimulation system

2011

Completed Phase 3

~20

Do I qualify?Apply below to find out

Find a site

Who is running the clinical trial?

Lee Fisher, PhDLead Sponsor

2 Previous Clinical Trials

25 Total Patients Enrolled

Media Library

Spinal cord stimulation system Clinical Trial Eligibility Overview. Trial Name: NCT04725006 — N/A

Amputation Research Study Groups: Stimulation in individuals with implanted stimulation systems

Amputation Clinical Trial 2023: Spinal cord stimulation system Highlights & Side Effects. Trial Name: NCT04725006 — N/A

Spinal cord stimulation system 2023 Treatment Timeline for Medical Study. Trial Name: NCT04725006 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current opportunities for enrolment in this research?

"Affirmative. The trial's presence on clinicaltrials.gov confirms that the study is actively looking for participants, which it has been doing since January 1st 2023 and last updated July 5th 2022. 30 individuals are needed to be recruited from one medical centre."

Answered by AI

Am I eligible to take part in this medical research?

"Eligible candidates for this research must have had amputations and be between 18-70 years of age. This specific trial is currently accepting up to 30 patients."

Answered by AI

Does this research include participants over 25 years of age?

"Patients older than 18 years but younger than 70 are eligible for this clinical trial."

Answered by AI

How many individuals are being invited to participate in this research?

"Affirmative, information found on clinicaltrials.gov indicates that this medical trial is actively enrolling patients as of now. It was initially posted on January 1st 2023 and subsequently revised July 5th 2022; the study aims to secure 30 individuals from one location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Sensory Responses to Dorsal Root Stimulation

Lee Fisher, PhD 2024. "Sensory Responses to Dorsal Root Stimulation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04725006.