Neuropathic PainNCT05811312
Brain Connectivity Changes With Spinal Cord Stimulation and Treatment of Chronic Pain: A Resting State NIRS/EEG Study
An observational study of Neuropathic Pain, run by VA Office of Research and Development at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuropathic Pain
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2023to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Veterans with chronic pain who are being treated as part of their clinical care with spinal cord stimulation
Who may be able to join
- 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.
Who cannot join
- Metal in the skull or deformity of the skull
- Pregnancy or pregnancy planning during the study period.
- Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Louis Stokes VA Medical Center, Cleveland, OH
Cleveland, Ohio, 44106-1702
Jessica P McCabe, MPT DPT, 216-791-3800 ext. 4691, Jessica.Mccabe@va.gov
Svetlana Pundik, MD, (216) 791-3800 ext. 3732, svetlana.pundik@va.gov
About this study
Official title: Brain Connectivity Changes With Spinal Cord Stimulation Treatment of Chronic Pain: A Resting State NIRS/EEG Study
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.
Read the detailed description
Chronic pain is a complex neurological disease that adversely impacts function and quality of life. Brain structure and function are altered when an individual is in the chronic pain state. Furthermore, chronic pain is associated with disruptions in functional brain connectivity. Spinal cord stimulation (SCS) is a clinically available non-pharmacological therapy that is used in the management of chronic pain. Although SCS is effective for many, there are individuals who do not benefit. Therefore, in order to better understand brain mechanisms that underlie SCS treatment of chronic pain and to develop brain biomarkers of SCS efficacy, the investigators propose to evaluate functional brain changes in response to SCS. Finding a brain signature of pain relief in response to SCS would improve understanding of how SCS alleviates chronic pain and may help to identify those most likely to respond. The main objective of this study is to assess changes in brain connectivity in response to SCS in individuals with chronic neuropathic pain. The investigators will study two cohorts: Cohort 1 - naïve to SCS patients who are undergoing SCS trial period; Cohort 1 - long-term SCS users ( 6 months post implantation). The investigators aim to identify neurophysiological brain signatures of pain relief in these two populations using resting state Near Infrared Spectroscopy and Electroencephalography (rs-fNIRS/EEG). Study Design: The investigators will enroll Veterans with refractory chronic neuropathic pain who are currently receiving clinical care within the medical center. Cohort 1: 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: 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. AIM 1 is to characterize neurophysiological (rs-fNIRS/EEG) brain signature of pain relief during the SCS trial period for patients with chronic neuropathic pain who are naïve to SCS. AIM 2 is to characterize neurophysiological (rs-fNIRS/EEG) brain signature of pain relief in patients with chronic neuropathic pain who have utilized SCS for 6 months. Outcome Measures to address both aims include rs-functional connectivity (rs-fNIRS/EEG); and a composite clinical pain assessment that will include Numeric Pain Rating Scale (NPRS), Patient Reported Outcomes Measurement Information System-29 profile v2.1(PROMIS-29); EQ-5D-5L; Patient Global Impression of Change (PGIC); painDetect; and activity monitoring. Significance: Studying changes in brain connectivity in response to SCS will provide insight into the treatment mechanism of SCS. Use of neuroimaging methods such as rs-fNIRS/EEG that can be easily applied in the clinical setting to further refine patient selection for SCS may improve outcome in SCS therapy. This grant will provide preliminary data for future studies aimed at developing biomarkers of pain-relief with SCS treatment.
- Conditions
- Neuropathic Pain
- Keywords
- chronic pain, neuropathic pain, spinal cord stimulation, fNIRS, electroencephalography
- Medical subject headings
- Neuralgia, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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.
Measured: 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
EQ-5D-5L is a 5-domain health-related quality of life measure; -0.59-1.00 scale, with 1=best health state.
Measured: 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)
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.
Measured: 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
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.
Measured: Cohort 1: day 1 and between days 5-9; Cohort 2: day 1 and between days 3-6
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.
Measured: Cohort 1: day 1 and between days 5-9; Cohort 2: day 1 and between days 3-6
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.
Measured: Cohort 1-between 5 and 9 days; Cohort 2-between 3-6 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2023
- Study start1 Jul 2023
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuropathic PainStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Svetlana Pundik, MD, Principal investigator, Louis Stokes VA Medical Center, Cleveland, OH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05811312
- Sponsor's protocol ID
- F4389-P
- Status last verified
- May 2026
- First submitted
- 30 Mar 2023
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Connectivity Changes With Spinal Cord Stimulation Treatment of Chronic Pain: A Resting State NIRS/EEG Study
- ClinicalTrials.gov ID
- NCT05811312
- Acronym / sponsor ID
- F4389-P
- Conditions
- Neuropathic Pain
- Keywords
- chronic pain, neuropathic pain, spinal cord stimulation, fNIRS, electroencephalography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 13 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic pain is a complex neurological disease that adversely impacts function and quality of life. Brain structure and function are altered when an individual is in the chronic pain state. Furthermore, chronic pain is associated with disruptions in functional brain connectivity. Spinal cord stimulation (SCS) is a clinically available non-pharmacological therapy that is used in the management of chronic pain. Although SCS is effective for many, there are individuals who do not benefit. Therefore, in order to better understand brain mechanisms that underlie SCS treatment of chronic pain and to develop brain biomarkers of SCS efficacy, the investigators propose to evaluate functional brain changes in response to SCS. Finding a brain signature of pain relief in response to SCS would improve understanding of how SCS alleviates chronic pain and may help to identify those most likely to respond. The main objective of this study is to assess changes in brain connectivity in response to SCS in individuals with chronic neuropathic pain. The investigators will study two cohorts: Cohort 1 - naïve to SCS patients who are undergoing SCS trial period; Cohort 1 - long-term SCS users ( 6 months post implantation). The investigators aim to identify neurophysiological brain signatures of pain relief in these two populations using resting state Near Infrared Spectroscopy and Electroencephalography (rs-fNIRS/EEG). Study Design: The investigators will enroll Veterans with refractory chronic neuropathic pain who are currently receiving clinical care within the medical center. Cohort 1: 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: 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. AIM 1 is to characterize neurophysiological (rs-fNIRS/EEG) brain signature of pain relief during the SCS trial period for patients with chronic neuropathic pain who are naïve to SCS. AIM 2 is to characterize neurophysiological (rs-fNIRS/EEG) brain signature of pain relief in patients with chronic neuropathic pain who have utilized SCS for 6 months. Outcome Measures to address both aims include rs-functional connectivity (rs-fNIRS/EEG); and a composite clinical pain assessment that will include Numeric Pain Rating Scale (NPRS), Patient Reported Outcomes Measurement Information System-29 profile v2.1(PROMIS-29); EQ-5D-5L; Patient Global Impression of Change (PGIC); painDetect; and activity monitoring. Significance: Studying changes in brain connectivity in response to SCS will provide insight into the treatment mechanism of SCS. Use of neuroimaging methods such as rs-fNIRS/EEG that can be easily applied in the clinical setting to further refine patient selection for SCS may improve outcome in SCS therapy. This grant will provide preliminary data for future studies aimed at developing biomarkers of pain-relief with SCS treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Veterans with chronic pain who are being treated as part of their clinical care with spinal cord stimulation
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- Metal in the skull or deformity of the skull
- Pregnancy or pregnancy planning during the study period.
- Unable to provide informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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)
Time frame: Cohort 1: day 1 and between days 5-9; Cohort 2: day 1 and between days 3-6
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.
5 secondary outcomes
Change in EQ-5D-5L
Time frame: 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)
Time frame: 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
Time frame: Cohort 1: day 1 and between days 5-9; Cohort 2: day 1 and between days 3-6
Change in PainDetect
Time frame: Cohort 1: day 1 and between days 5-9; Cohort 2: day 1 and between days 3-6
Change in Actigraphy
Time frame: Cohort 1-between 5 and 9 days; Cohort 2-between 3-6 days.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Svetlana Pundik, MD principal investigator
Louis Stokes VA Medical Center, Cleveland, OH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuropathic Pain, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cheryl Dudek ((216) 679-3800, cheryl.dudek@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.