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

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
VA Office of Research and Development
Study ID
NCT05811312
Status
Recruiting
Apply to this trial

Conditions

  • Neuropathic Pain

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Jul 1, 2023
Status verified
May 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Change in resting state Functional Connectivity [ Time Frame: Cohort 1: day 1 and between days 5-9; Cohort 2: day 1 and between days 3-6 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Louis Stokes VA Medical Center, Cleveland, OHClevelandOhio44106-1702
Jessica P McCabe, MPT DPT
[email protected]
216-791-3800
Svetlana Pundik, MD
[email protected]
(216) 791-3800
Svetlana Pundik, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Cleveland, OH

By research site
Louis Stokes VA Medical Center, Cleveland, OH· Cleveland, OH

Related Studies