Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain

October 6, 2023 updated by: Scott Lempka, University of Michigan

CRCNS: Model-based Characterization of Spinal Cord Stimulation for Pain

Doctors sometimes treat chronic pain with devices that send mild electrical currents into the spinal cord. This type of treatment is referred to as neurostimulation. A common form of neurostimulation therapy is spinal cord stimulation (SCS). In this study, researchers want to learn more about how SCS affects pain processing and relieves pain. The researchers will examine multiple forms of SCS in chronic pain patients who are receiving SCS from their own doctors as part of their standard of care. During the study, participants will be asked to complete a variety of evaluations at certain time points.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  • Chronic intractable pain of the trunk and/or limbs
  • Undergoing SCS as part of standard clinical care for chronic pain management
  • Candidates will have been implanted with a commercial SCS device
  • Candidates who are 18 years or older and can speak, read, and understand English
  • Able to understand study procedures and to comply with them for the entire length of the study
  • Must be willing to participate in COVID-19 symptom screening and answer questions about COVID-19 diagnosis 1-3 days before a scheduled visit
  • Must be willing to wear a face-covering during all study visits

Exclusion criteria:

  • Subjects who are pregnant or nursing
  • Subjects with current, habitual, or previous use within the last 12 months of artificial nails, nail enhancements, or nail extensions that cover any portion of either thumbnail
  • Subjects who are unable or unwilling to cooperate with clinical testing
  • Subjects having any impairment, activity or situation that in the judgment of study personnel would prevent satisfactory completion of the study protocol
  • Inability or unwillingness of individual or legal guardian/representative to give written informed consent
  • Subjects who currently have or tested positive in the last 14 days for COVID-19, or are symptomatic for COVID-19

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Burst / kHz / Sham / Tonic
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
Device: Spinal cord stimulation
Researchers will program the spinal cord stimulation (SCS) system to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.
Experimental: Burst / Sham / kHz / Tonic
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
Device: Spinal cord stimulation
Researchers will program the spinal cord stimulation (SCS) system to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.
Experimental: kHz / Sham / Burst / Tonic
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
Device: Spinal cord stimulation
Researchers will program the spinal cord stimulation (SCS) system to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.
Experimental: kHz / Burst / Sham / Tonic
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
Device: Spinal cord stimulation
Researchers will program the spinal cord stimulation (SCS) system to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.
Experimental: Sham / Burst / kHz / Tonic
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
Device: Spinal cord stimulation
Researchers will program the spinal cord stimulation (SCS) system to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.
Experimental: Sham / kHz / Burst / Tonic
Participants will be randomized to one of six treatment arms. Participants will receive burst, kHz, tonic, and sham spinal cord stimulation (SCS). Each treatment will be applied for a duration of seven days. Participants will be blinded during programming.
Device: Spinal cord stimulation
Researchers will program the spinal cord stimulation (SCS) system to deliver, according to the randomization status of the participant, burst, kHz, tonic, and sham stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SCS-induced changes in temporal summation (TS)
Time Frame: Baseline (At randomization) and at the end of each seven-day treatment
TS refers to an increased perception of pain in response to sequential stimuli of equal physical strength. At the end of each treatment period, TS scores will be calculated by subtracting the average pain rating of the single-stimulus trials from the average pain rating of the ten-stimuli trials. If the difference is a positive number, the researchers will conclude that there was pain summation, where larger numbers will indicate increased pain summation or TS. If the difference is zero or a negative number, the researchers will conclude that there was no pain summation or TS.
Baseline (At randomization) and at the end of each seven-day treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Collaborators

National Center for Complementary and Integrative Health (NCCIH)

Investigators

  • Principal Investigator: Scott Lempka, PhD, University of Michigan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 11, 2021

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

January 27, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 1, 2021

Study Record Updates

Last Update Posted (Estimated)

October 10, 2023

Last Update Submitted That Met QC Criteria

October 6, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00164430
  • R01AT010817 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans to share IPD at this time.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Chronic Pain

Clinical Trials on Spinal cord stimulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe