Recruiting

Spinal Cord Stimulation

Sponsor:

VA Office of Research and Development

Code:

NCT05811312

Conditions

Neuropathic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT05811312

Start date

Jul 1, 2023

Status verified date

May, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

40 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Change in resting state Functional Connectivity [ Time Frame: 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) [ Time Frame: Cohort 1: day 1 and between days 5-9; Cohort 2: day 1 and between days 3-6 ]

Central Contacts and Locations

Central contacts

Cheryl Dudek

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

Holly B Henry

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

Locations

Louis Stokes VA Medical Center, Cleveland, OH

Recruiting

Cleveland, Ohio, United States, 44106-1702

Contacts

Jessica P McCabe, MPT DPT

216-791-3800Jessica.Mccabe@va.gov

Svetlana Pundik, MD

(216) 791-3800svetlana.pundik@va.gov

Principal Investigator:

Svetlana Pundik, MD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-06-01.