Examining brain changes in veterans with chronic pain using spinal cord stimulation
Brain Connectivity Changes With Spinal Cord Stimulation Treatment of Chronic Pain: A Resting State NIRS/EEG Study
This study is testing how spinal cord stimulation affects the brains of veterans with chronic pain to see if it helps them feel better.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT05811312 on ClinicalTrials.gov |
What this trial studies
This observational study investigates how spinal cord stimulation (SCS) affects brain structure and function in veterans suffering from chronic neuropathic pain. Utilizing non-invasive neuroimaging techniques, specifically resting state Near Infrared Spectroscopy and Electroencephalography (rs-fNIRS/EEG), the study will enroll two cohorts: those new to SCS and long-term users. The goal is to identify neurophysiological signatures associated with pain relief, which may enhance understanding of SCS efficacy and help predict patient responses to treatment.
Who should consider this trial
Good fit: Ideal candidates are US veterans aged 18 and older with a diagnosis of chronic neuropathic pain who are current patients at the Cleveland VA Medical Center.
Not a fit: Patients with metal in the skull, pregnancy, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved identification of patients who are likely to benefit from spinal cord stimulation for chronic pain relief.
How similar studies have performed: While the approach of using neuroimaging to assess brain changes in response to SCS is innovative, similar studies have shown promise in understanding brain mechanisms related to pain management.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Metal in the skull or deformity of the skull * Pregnancy or pregnancy planning during the study period. * Unable to provide informed consent.
Where this trial is running
Cleveland, Ohio
- Louis Stokes VA Medical Center, Cleveland, OH — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Svetlana Pundik, MD — Louis Stokes VA Medical Center, Cleveland, OH
- Study coordinator: Cheryl Dudek
- Email: cheryl.dudek@va.gov
- Phone: (216) 679-3800
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.