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Brain Connectivity Changes with Spinal Cord Stimulation for Chronic Pain

This observational study is looking at how spinal cord stimulation (SCS), a non-drug therapy for chronic pain, affects brain activity and structure. Researchers will use special imaging techniques called resting state Near Infrared Spectroscopy and Electroencephalography (rs-fNIRS/EEG) to measure brain changes. They will enroll U.S. Veterans with chronic neuropathic pain who are either already using SCS or are trying it out. The study aims to see if SCS changes how different parts of the brain communicate, and if these changes are linked to pain relief. Success will be measured by changes in brain connectivity and how much pain you report on a scale. The study is currently unclear on its recruitment status.

Study design
This is an observational study planning to enroll 40 participants. It will look at two groups: those new to SCS and those who have used it long-term.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your brain connectivity and pain levels will be measured at the start and again between 3-9 days later, depending on your group.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05811312

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

Recruiting
Not specifiedAges 18+Observational
VA Office of Research and Development
~40 participants
Updated 2026-06-01 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in resting state Functional Connectivity
Measured over Cohort 1: day 1 and between days 5-9; Cohort 2: day 1 and between days 3-6
+1 more outcome measured

Conditions

Neuropathic Pain

Explore related trials

Chronic PainNeuropathic Pain

Where it's being run

1 sites across 1 states
Ohio1

Study leadership

  • Svetlana Pundik, MD · PRINCIPAL_INVESTIGATOR · Louis Stokes VA Medical Center, Cleveland, OH

Who to contact

Cheryl Dudek
[email protected]
(216) 679-3800
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

Metal in the skull or deformity of the skull
Pregnancy or pregnancy planning during the study period.
Unable to provide informed consent.

What this trial measures

  • Change in resting state Functional ConnectivityCohort 1: day 1 and between days 5-9; Cohort 2: day 1 and between days 3-6

    Resting state functional connectivity will be evaluated with fNIRS and EEG. The investigators will model "response to SCS" with changes in resting state functional connectivity between five bilateral cortical regions. These regions are the medial prefrontal cortex (mPF), dorsolateral prefrontal cortex (DLPFC), primary motor cortex (M1), primary sensory cortex (S1), and posterior parietal cortex (PPC). Brain connectivity will be evaluated with fNIRS and EEG. Prefrontal medial cortex and posterior temporoparietal regions are good proxy measures of DMN activity using fNIRS. 45-47 DMN nodes include additional deep brain structures but they are outside the field of view for most fNIRS instruments. The investigators will evaluate S1 for its role in pain processing, M1 for its contribution to pain sensation via thalamic inhibition, and DLPFC for its known role in cognitive and affective pain processing.

  • Change in Numeric Pain Rating Scale (NPRS)Cohort 1: day 1 and between days 5-9; Cohort 2: day 1 and between days 3-6

    NPRS measures pain intensity. Individuals select a number on a 0-10 scale that best describes the intensity of their current, best and worst pain levels; 0-10 scale, with 10 indicating maximum pain.