Brain Connectivity Changes With Spinal Cord Stimulation Treatment of Chronic Pain: A Resting State NIRS/EEG Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

This study aims to assess how use of spinal cord stimulation for the treatment of chronic pain impacts brain structure and function. The investigators will use a non-invasive neuroimaging technique called resting state Near Infrared Spectroscopy and Electroencephalography (rs-fNIRS/EEG). The investigators will enroll Veterans who are currently receiving care at the Medical Center and who are either long term users of SCS for the treatment of their chronic pain or being evaluated for use of SCS to treat their pain.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years of age and a US veteran

• Diagnosis of chronic neuropathic pain.

• Current patient at Cleveland VA Medical Center receiving care via Pain Medicine Center.

• Current user of tonic parasthesia-based SCS (pain relief 50% according to NPRS) or undergoing trial SCS period as part of clinical care.

• Able to provide informed consent.

• Medically and psychologically stable.

Locations
United States
Ohio
Louis Stokes VA Medical Center, Cleveland, OH
RECRUITING
Cleveland
Contact Information
Primary
Cheryl Dudek
cheryl.dudek@va.gov
(216) 679-3800
Backup
Holly B Henry
holly.henry@va.gov
(216) 791-3800
Time Frame
Start Date: 2023-07-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 40
Treatments
Cohort 1-individuals who are naïve to SCS
Individuals with chronic neuropathic pain who are naïve to SCS and were selected for SCS trial period as part of their clinical care will participate in two study visits: before the beginning of the SCS trial and the end of the trial period. Data collection will be consistent across all data collection timepoints (T1 - T3) and include rs-fNIRS/EEG and clinical pain measures.
Cohort 2-individuals with effective implanted SCS 6 months
Cohort 2: Participants with effective implanted SCS 6 months will participate in three study visits conducted 24-48 hours apart. Data will be collected during SCS use and following an SCS washout period. Data collection will be consistent across all data collection timepoints(T1-T4) and include rs-fNIRS/EEG and clinical pain measures. Both cohorts will receive paresthesia based SCS.
Related Therapeutic Areas
Sponsors
Leads: VA Office of Research and Development

This content was sourced from clinicaltrials.gov