Neuropathic Pain Clinical Trial
Official title:
Brain Connectivity Changes With Spinal Cord Stimulation Treatment of Chronic Pain: A Resting State NIRS/EEG Study
NCT number | NCT05811312 |
Other study ID # | F4389-P |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | July 1, 2023 |
Est. completion date | July 1, 2025 |
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.
Status | Recruiting |
Enrollment | 40 |
Est. completion date | July 1, 2025 |
Est. primary completion date | July 1, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Louis Stokes VA Medical Center, Cleveland, OH | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | Change in EQ-5D-5L | EQ-5D-5L is a 5-domain health-related quality of life measure; -0.59-1.00 scale, with 1=best health state. | Cohort 1: day 1 and between days 5-9; Cohort 2: day 1 and between days 3-6 | |
Secondary | Change in Patients Global Impression of Change (PGIC) | Patient's Global Impression of Change (PGIC) is a 7-point scale to assess patient perception of change in response to treatment. 1=no change, and 7=a great deal better. | Cohort 1: day 1 and between days 5-9; Cohort 2: day 1 and between days 3-6 | |
Secondary | Change in PROMIS-29 Profile v2.1 | PROMIS-29 Profile v2.1 is a questionnaire covering 7 domains including physical function, anxiety, depression, fatigue, sleep disturbance, participation in social roles/activities, and pain interference. Higher T-scores indicate more severity/worse health. | Cohort 1: day 1 and between days 5-9; Cohort 2: day 1 and between days 3-6 | |
Secondary | Change in PainDetect | PainDetect is a self-report measure that was developed to assess neuropathic pain in adults with low back pain; 0-38 points, with higher score more indicative of neuropathic pain. | Cohort 1: day 1 and between days 5-9; Cohort 2: day 1 and between days 3-6 | |
Secondary | Change in Actigraphy | Activity monitoring using a wrist-worn device (Actigraphy) will be utilized to monitor real-life activity and sleep patterns; calculating % time active versus sedentary. | Cohort 1-between 5 and 9 days; Cohort 2-between 3-6 days. |
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