About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Metal in the skull or deformity of the skull
Pregnancy or pregnancy planning during the study period.
Unable to provide informed consent.
Trial population
Veterans with chronic pain who are being treated as part of their clinical care with spinal cord stimulation
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Change in resting state Functional Connectivity
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)
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.
Secondary outcomes
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.
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.
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.
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.
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