RecruitingNot Applicable

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

United States40 participantsStarted 2023-07-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in resting state Functional Connectivity

Timeframe: Cohort 1: day 1 and between days 5-9; Cohort 2: day 1 and between days 3-6

Change in Numeric Pain Rating Scale (NPRS)

Timeframe: Cohort 1: day 1 and between days 5-9; Cohort 2: day 1 and between days 3-6

Trial details

NCT IDNCT05811312

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeOBSERVATIONAL

Primary completion2027-06-30

Contact for this trial

Cheryl Dudek

(216) 679-3800 cheryl.dudek@va.gov

View on ClinicalTrials.gov More Neuropathic Pain trials