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Spinal Cord Stimulation for Phantom Limb Pain

N/A

Recruiting

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 undergoing an epidural spinal cord implanted electrode array clinical trial with Dr. Helm for the management of pain.

Subjects must be between the ages of 18 and 70 years old.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 days

Awards & highlights

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.

Who is the study for?

This trial is for individuals aged 18-70 with Phantom Limb Syndrome or similar conditions, who are already part of a pain management clinical trial involving an epidural spinal cord stimulator. Participants must understand the consent process and procedures.Check my eligibility

What is being tested?

The study tests how different sensations can be created by electrically stimulating the spinal cord using implanted devices. It aims to control sensation type, intensity, and location through these devices while participants report their experiences.See study design

What are the potential side effects?

While specific side effects aren't listed, electrical stimulation may cause discomfort, skin irritation at the electrode sites, unexpected changes in sensation or pain levels, and potential interference with other electronic medical devices.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am part of Dr. Helm's clinical trial for pain management using an epidural spinal cord electrode.

Select...

I am between 18 and 70 years old.

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

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Lee Fisher, PhDLead Sponsor

3 Previous Clinical Trials

35 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.

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