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

NCT05811312 | Recruiting

• 1 other identifier: F4389-P
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuropathic Pain

Keywords

chronic pain; neuropathic pain; spinal cord stimulation; fNIRS; electroencephalography

Outcome Measures

Primary Outcomes (2)

• Change in resting state Functional Connectivity

  resting state functional connectivity will be evaluated with fNIRS and EEG. We 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 structures18 but they are outside the field of view for most fNIRS instruments. We 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.

  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 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.

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

Secondary Outcomes (5)

• Change in EQ-5D-5L

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

• Change in Patients Global Impression of Change (PGIC)

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

• Change in PROMIS-29 Profile v2.1

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

• Change in PainDetect

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

• Change in Actigraphy

  Cohort 1-between 5 and 9 days; Cohort 2-between 3-6 days.

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Veterans with chronic pain who are being treated as part of their clinical care with spinal cord stimulation

You may qualify if:

• 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 may not qualify if:

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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Louis Stokes VA Medical Center, Cleveland, OH

Cleveland, Ohio, 44106-1702, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

fNIRS/EEG, Numeric pain rating scale, EQ-5D-5L, Patients Global Impression of Change, PROMIS-29 Profile v2.1, PainDetect and Actigraphy

MeSH Terms

Conditions

Neuralgia; Chronic Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Svetlana Pundik, MD

  Louis Stokes VA Medical Center, Cleveland, OH

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cheryl Dudek

CONTACT

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

Holly B Henry

CONTACT

(216) 791-3800; holly.henry@va.gov

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 13, 2023
• Study Start: July 1, 2023
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)