Actively Recruiting
Brain Connectivity Changes With Spinal Cord Stimulation Treatment of Chronic Pain: A Resting State NIRS/EEG Study
Led by VA Office of Research and Development · Updated on 2026-06-01
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating how spinal cord stimulation (SCS) affects brain structure and function in people with chronic neuropathic pain. The study aims to understand brain changes linked to pain relief from SCS using a non-invasive imaging method called resting state Near Infrared Spectroscopy and Electroencephalography (rs-fNIRS/EEG). The study involves veterans who either are new to SCS treatment or have been using it long-term. Participants are divided into two groups: those new to SCS undergoing a trial period, and those who have had an implanted SCS device for at least six months. The new users will have two study visits, one before starting the trial and one after the trial period, with brain imaging and clinical pain assessments. Long-term users will have three visits over 24 to 48 hours, including times during active SCS use and after a washout period without stimulation. Both groups receive paresthesia-based SCS as part of their care. During the visits, participants will undergo brain scans using rs-fNIRS/EEG and complete various clinical pain questionnaires such as the Numeric Pain Rating Scale and Patient Reported Outcomes Measurement Information System-29. Activity monitoring will also be done. Researchers will study changes in brain connectivity and pain levels to identify brain signatures related to pain relief. This research will help improve understanding of how SCS works and may lead to better patient selection for this therapy. The study is expected to continue until June 2027.
CONDITIONS
Brief Title
Brain Connectivity Changes With Spinal Cord Stimulation and Treatment of Chronic Pain: A Resting State NIRS/EEG Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Metal in the skull or deformity of the skull
- Pregnancy or pregnancy planning during the study period
- Unable to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 5 to 9 days
Participants who are naïve to spinal cord stimulation (SCS) undergo brain connectivity assessments before and after their clinical SCS trial period to evaluate changes in brain function and pain relief.
2 visits (in-person) before and after the SCS trial period
Duration - 3 to 6 days
Participants with implanted SCS devices for 6 months undergo brain connectivity assessments during SCS use and following an SCS washout period to study neurophysiological changes associated with pain relief.
3 visits (in-person) conducted 24-48 hours apart
Trial Site Locations
Total: 1 location
1
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, United States, 44106-1702
Actively Recruiting
Research Team
C
Cheryl Dudek
H
Holly B Henry
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here