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Spinal Cord Stimulation

Study Group for Complex Regional Pain Syndrome

N/A

Recruiting

Research Sponsored by Albany Medical College

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 month

Awards & highlights

Study Summary

This trialis testing the safety and effectiveness of a new research electrode to answer basic physiological questions, but won't be sold or marketed. It's a low-risk study.

Who is the study for?

This trial is for English-speaking, mentally competent individuals who are undergoing spinal cord stimulation procedures to manage neuropathic pain. Participants must be able to give informed consent and complete questionnaires and pain assessments.Check my eligibility

What is being tested?

The study is testing the safety and effectiveness of a new type of spinal cord stimulation paddle electrode designed to target specific areas in the spine related to pain signaling. This research tool aims to gather data that could help develop future therapies.See study design

What are the potential side effects?

Since this is an observational study focusing on a device during surgery rather than a drug, side effects may include typical surgical risks such as infection, bleeding, or discomfort at the implant site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 month

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 month

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 month for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Numeric Rating Scale

Secondary outcome measures

Beck Depression Index (BDI)

McGill Pain Questionnaire (MPQ)

Oswestry Disability Index (ODI)

+1 more

Other outcome measures

PainDetect

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study GroupExperimental Treatment1 Intervention

Twenty-four patients offered SCS for standard of care were also invited to participate in this study, in which a study electrode was temporarily placed intraoperatively and neuromonitoring was done per our routine standard-of-care

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

HD Study Electrode

2020

N/A

~20

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Albany Medical CollegeLead Sponsor

91 Previous Clinical Trials

11,477 Total Patients Enrolled

Frequently Asked Questions

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

Is there an age restriction for enrolment in this research project?

"As outlined in the eligibility requirements, applicants must be between 18 and 90 years of age to partake in this clinical trial."

Answered by AI

Is this experiment still accepting participants?

"Correct. The study, first made public on June 8th 2022, is still open for recruitment according to clinicaltrials.gov data - a total of 20 patients are needed from one medical centre. This information was last updated on February 7th 2023."

Answered by AI

What is the uppermost participant limit for this research endeavor?

"Affirmative. According to the data on clinicaltrials.gov, this medical trial is currently enlisting participants. The trial was first made available June 8th 2022 and was last amended February 7th 2023, with a goal of finding 20 patients from 1 site."

Answered by AI

Are there eligibility criteria that I must meet to participate in this experiment?

"This clinical trial is open to individuals aged 18-90 with complex regional pain syndrome (CRPS) who meet the following criteria: they have received a spinal cord stimulation procedure for neuropathic pain, are proficient in English and capable of providing informed consent, as well as completing questionnaires and exams assessing their level of discomfort. The study will admit 20 participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Intraoperative Neuromonitoring Recording With a Novel SCS Paddle: Phase II

2022. "Intraoperative Neuromonitoring Recording With a Novel SCS Paddle: Phase II". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05459324.

All > Scs