Chronic Neuropathic PainTRC-AB-1NCT06647576
Exploring Neurosphere's Remote Monitoring and Virtual Clinic Features in Improve Quality of Life and Reduce Costs
An observational study of Chronic Neuropathic Pain and Chronic Pain Management, run by Mahesh Pattabiraman at 1 site in United States.
Trial summary
This study evaluates the effectiveness of Abbott's Proclaim™ and Eterna™ Spinal Cord Stimulator (SCS) systems, along with the Neurosphere™ virtual clinic platform, in managing chronic pain. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Chronic Neuropathic Pain, Chronic Pain Management, Spinal Cord Stimulation (SCS)
- What is being tested?
- Spinal Cord Stimulation - In Clinic and Spinal Cord Stimulation - Neurosphere
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Oct 2024to 7 May 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study will include adult participants aged 19 years and older who are experiencing chronic neuropathic pain that is refractory to medical treatment and are eligible for SCS therapy based on FDA-approved indications. Participants will be recruited from a rural population, with effort made for including individuals from diverse socioeconomic backgrounds. Study will enroll patients who can legally provide consent and are willing to adhere to the study protocol, including remote monitoring or in-person follow-up visits.
Who may be able to join
- Adults aged 19 years and older experiencing chronic neuropathic pain that is refractory to medical treatment and eligible for SCS based on FDA-approved indications.
- Individuals who can legally provide informed consent.
Who cannot join
- Patients unable or unwilling to adhere to the requirements of remote monitoring, follow-up schedules, or other aspects of the study protocol.
- Patients with uncontrolled psychiatric conditions, including severe depression or anxiety, which could interfere with their ability to participate fully in the study or accurately report outcomes.
- Women who are currently pregnant or breastfeeding, as the safety and efficacy of SCS in these populations are not established.
- Patients who have previously experienced significant adverse events or complications from SCS implantation or stimulation that would make further use unsafe or ineffective.
- Patients with other active implantable devices (e.g., pacemakers or defibrillators) that could interfere with the functionality of the SCS system.
- Patients with a documented history of substance abuse within
- Patients with significant comorbid conditions (severe cardiovascular disease, unmanaged diabetes, uncontrolled infection, etc.)
Trial locations and contacts
1 site in 1 country.
United States1 site
Grand Island Pain Relief Center
Grand Island, Nebraska, 68803
About this study
Official title: Abbott Neurosphere™ Pilot Study: Remote Monitoring and Virtual Clinic Features in Improving Quality of Life and Potential Cost-Saving
This study evaluates the effectiveness of Abbott's Proclaim™ and Eterna™ Spinal Cord Stimulator (SCS) systems, along with the Neurosphere™ virtual clinic platform, in managing chronic pain. The goal is to assess how remote monitoring and virtual care can improve pain relief and reduce healthcare costs compared to traditional in-person care. Adults with chronic pain will either receive treatment through in-person visits or remotely using Neurosphere™. The study will measure pain relief, quality of life, and healthcare expenses over six months, aiming to improve access to pain management, especially for patients in rural areas.
- Conditions
- Chronic Neuropathic Pain, Chronic Pain Management, Spinal Cord Stimulation (SCS), Pain Modulation, Failed Back Surgery Syndrome
- Being tested
- Spinal Cord Stimulation - In Clinic, Spinal Cord Stimulation - Neurosphere
- Keywords
- chronic pain, spinal cord stimulation, neuropathic pain, Remote Pain Management, BurstDR Technology, Chronic Pain in Rural Populations
- Medical subject headings
- Failed Back Surgery Syndrome, Chronic Pain, Neuralgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal Cord Stimulation - In ClinicDevice
Also called neuromodulation, In Person SCS
Control Group Intervention: In-Person SCS therapy. Device settings, such as pulse width and frequency, will be adjusted during regular clinic visits. Follow-up assessments for pain relief, quality of life, and therapy effectiveness will occur at 1, 3, and 6-month intervals over a 6-month period.
Spinal Cord Stimulation - NeurosphereDevice
Also called Remote Pain Management
Test Group Intervention: Test group participants will receive remote monitoring and therapy adjustments through the Neurosphere™ virtual clinic platform. Participants in test group will have trial and end of trial phases in clinic, but further SCS therapy will be performed through Neurosphere. Clinicians will adjust the SCS device settings, including pulse width and burst frequency, remotely. This intervention allows patients to avoid in-person visits while receiving continuous, personalized care, with follow-up assessments at 1, 3, and 6 months over a 6-month period.
| Study group | Role | What they receive |
|---|---|---|
| Test | Patients receiving SCS therapy through Neutrosphere virtual clinic platform (remote pain management group). Receives: Device: Spinal Cord Stimulation - Neurosphere | |
| Control Group | Participants in this group will receive traditional in-person care for their SCS therapy. Group regular clinic visits for therapy adjustments, monitoring, and pain management Receives: Device: Spinal Cord Stimulation - In Clinic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Relief - NRS
Pain relief in numerical pain rating scale (NRS). Numerical points.
Measured: Baseline, 1 month, 3 months, and 6 months post-intervention
Quality of Life and Functional Disability Improvements - ODI
Change in quality of life and functional disability in participants quantified through numerical response to Oswestry Disability Index (ODI) compared to baseline
Measured: Baseline, 1 month, 3 months, and 6 months post-intervention
Healthcare Cost Reduction
This outcome measures the reduction in healthcare costs associated with the use of the Neurosphere™ remote monitoring platform compared to traditional in-person care. Costs will be assessed through an analysis of healthcare resource utilization using time-driven activity-based costing TDABC methodology.
Measured: From baseline to 6 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start8 Oct 2024
- Primary completion30 Apr 2026
- Study completion7 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neuropathic PainStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahesh Pattabiraman
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor-investigator, Mahesh Pattabiraman, TriCity Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06647576
- Sponsor's protocol ID
- IIS-24-ABT-001
- Acronym
- TRC-AB-1
- Status last verified
- May 2026
- First submitted
- 14 Oct 2024
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: IPD related to the primary and secondary outcomes of the study, including anonymized data on pain relief, quality of life, healthcare utilization, and cost-effectiveness, will be shared. The shared data will include patient-reported outcomes (e.g., ODI and NRS for pain), as well as relevant clinical and financial data collected throughout the study. A detailed data dictionary, explaining all variables, will be provided to ensure proper interpretation. IPD will be made available upon reasonable request after publication of the study results
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abbott Neurosphere™ Pilot Study: Remote Monitoring and Virtual Clinic Features in Improving Quality of Life and Potential Cost-Saving
- ClinicalTrials.gov ID
- NCT06647576
- Acronym / sponsor ID
- TRC-AB-1 / IIS-24-ABT-001
- Conditions
- Chronic Neuropathic Pain, Chronic Pain Management, Spinal Cord Stimulation (SCS), Pain Modulation, Failed Back Surgery Syndrome
- Keywords
- chronic pain, spinal cord stimulation, neuropathic pain, Remote Pain Management, BurstDR Technology, Chronic Pain in Rural Populations
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Mahesh PattabiramanIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 30 Apr 2026 (actual)
- Study completion
- 7 May 2026 (actual)
- First posted
- 18 Oct 2024 (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 evaluates the effectiveness of Abbott's Proclaim™ and Eterna™ Spinal Cord Stimulator (SCS) systems, along with the Neurosphere™ virtual clinic platform, in managing chronic pain. The goal is to assess how remote monitoring and virtual care can improve pain relief and reduce healthcare costs compared to traditional in-person care. Adults with chronic pain will either receive treatment through in-person visits or remotely using Neurosphere™. The study will measure pain relief, quality of life, and healthcare expenses over six months, aiming to improve access to pain management, especially for patients in rural areas.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test | – | Device: Spinal Cord Stimulation - NeurospherePatients receiving SCS therapy through Neutrosphere virtual clinic platform (remote pain management group). |
| Control Group | – | Device: Spinal Cord Stimulation - In ClinicParticipants in this group will receive traditional in-person care for their SCS therapy. Group regular clinic visits for therapy adjustments, monitoring, and pain management |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include adult participants aged 19 years and older who are experiencing chronic neuropathic pain that is refractory to medical treatment and are eligible for SCS therapy based on FDA-approved indications. Participants will be recruited from a rural population, with effort made for including individuals from diverse socioeconomic backgrounds. Study will enroll patients who can legally provide consent and are willing to adhere to the study protocol, including remote monitoring or in-person follow-up visits.
Key inclusion criteria (2 listed)
- Adults aged 19 years and older experiencing chronic neuropathic pain that is refractory to medical treatment and eligible for SCS based on FDA-approved indications.
- Individuals who can legally provide informed consent.
Key exclusion criteria (7 listed)
- Patients unable or unwilling to adhere to the requirements of remote monitoring, follow-up schedules, or other aspects of the study protocol.
- Patients with uncontrolled psychiatric conditions, including severe depression or anxiety, which could interfere with their ability to participate fully in the study or accurately report outcomes.
- Women who are currently pregnant or breastfeeding, as the safety and efficacy of SCS in these populations are not established.
- Patients who have previously experienced significant adverse events or complications from SCS implantation or stimulation that would make further use unsafe or ineffective.
- Patients with other active implantable devices (e.g., pacemakers or defibrillators) that could interfere with the functionality of the SCS system.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal Cord Stimulation - In ClinicAlso: neuromodulation, In Person SCSControl Group Intervention: In-Person SCS therapy. Device settings, such as pulse width and frequency, will be adjusted during regular clinic visits. Follow-up assessments for pain relief, quality of life, and therapy effectiveness will occur at 1, 3, and 6-month intervals over a 6-month period. | Device | Control Group |
| Spinal Cord Stimulation - NeurosphereAlso: Remote Pain ManagementTest Group Intervention: Test group participants will receive remote monitoring and therapy adjustments through the Neurosphere™ virtual clinic platform. Participants in test group will have trial and end of trial phases in clinic, but further SCS therapy will be performed through Neurosphere. Clinicians will adjust the SCS device settings, including pulse width and burst frequency, remotely. This intervention allows patients to avoid in-person visits while receiving continuous, personalized care, with follow-up assessments at 1, 3, and 6 months over a 6-month period. | Device | Test |
Primary outcome
Pain Relief - NRS
Time frame: Baseline, 1 month, 3 months, and 6 months post-intervention
Pain relief in numerical pain rating scale (NRS). Numerical points.
Quality of Life and Functional Disability Improvements - ODI
Time frame: Baseline, 1 month, 3 months, and 6 months post-intervention
Change in quality of life and functional disability in participants quantified through numerical response to Oswestry Disability Index (ODI) compared to baseline
Healthcare Cost Reduction
Time frame: From baseline to 6 months post-intervention
This outcome measures the reduction in healthcare costs associated with the use of the Neurosphere™ remote monitoring platform compared to traditional in-person care. Costs will be assessed through an analysis of healthcare resource utilization using time-driven activity-based costing TDABC methodology.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Yes. IPD related to the primary and secondary outcomes of the study, including anonymized data on pain relief, quality of life, healthcare utilization, and cost-effectiveness, will be shared. The shared data will include patient-reported outcomes (e.g., ODI and NRS for pain), as well as relevant clinical and financial data collected throughout the study. A detailed data dictionary, explaining all variables, will be provided to ensure proper interpretation. IPD will be made available upon reasonable request after publication of the study results
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Chronic Neuropathic Pain and Chronic Pain Management, run by Mahesh Pattabiraman 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 2 inclusion and 7 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: finished, as of the sponsor's last update on 8 May 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Relief - NRS (time frame: Baseline, 1 month, 3 months, and 6 months post-intervention). The study lists 3 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 8 May 2026.