Sensory Testing of Multiple Forms of Spinal Cord Stimulation for Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04732325
• Other study ID #: HUM00164430
• Secondary ID: R01AT010817
• Status: Recruiting
• Phase: N/A
• Start date: September 11, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: October 2023
• Source: University of Michigan
• Contact: Scott Lempka, PhD
• Phone: 734-647-9052
• Email: NeuromodulationLab[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Complex Regional Pain Syndromes
• Failed Back Surgery Syndrome
• Neuralgia
• Neuropathic Pain
• Reflex Sympathetic Dystrophy
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCS-induced changes in temporal summation (TS)	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