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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVA Office of Research and Development

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

40 Participants
are grouped into 2 trial groups
Group A: Cohort 1-individuals who are naïve to SCS
Group B: Cohort 2-individuals with effective implanted SCS 6 months

Trial outcomes

Primary outcomes

1

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.

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

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.

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

Secondary outcomes

1

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.

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

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.

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

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.

Time frame
Cohort 1: day 1 and between days 5-9; Cohort 2: day 1 and between days 3-6
4

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.

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

Other outcomes

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