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Research Projects

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ReActiv8-B Study (2016 - 2023)
 

 

A prospective multi-centre trial evaluating the safety and efficacy of the ReActiv8 restorative neurostimulation system alongside medical management for the treatment of adults with chronic lower back pain and no prior surgery. 

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Real World Data for Spinal Cord Stimulation – Ethnic Minorities and Social Deprivation 
(2021 - 2022)

 

A retrospective analysis comparing outcome measures in spinal cord stimulation patients in ethnic minority and non-ethnic minority patients. 

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Boston Virgin Back Study
(2019 - 2024)

 

An investigator initiated pilot study investigating the response to 1000Hz high frequency stimulation in participants with intractable neuropathic pain who have not previously undergone spinal surgery.

This study has now been completed and its data has been published.

Precision Retrospective Outcomes (PRO) Study

 

An ongoing commercial retrospective study that is collecting clinical outcomes for patients undergoing spinal cord stimulation using the Boston Scientific Wavewriter Alpha device.  This study is currently recruiting.  

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Multifidus PET Scan (MUST) Study 

This is an investigator initiated prospective single arm study assessing  Multifidus Activity Resulting from Restorative Neurostimulation using Novel 18FDG-PET-CT Radiomics. This study will help elucidate the mechanism of action behind restorative multifidus stimulation.

This study has now finished recruitment and Phase 1 data has been presented and submitted for publication.

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Central Sensitisation Response following Occipital Nerve Stimulation (ONS QST) Study

 

This is a prospective study investigating peripheral and central sensitisation in patents undergoing Occipital Nerve Stimulation for trigeminal autonomic cephalgias.  This study is currently recruiting.  

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Multifidus PET Scan (MUST) Study 

 

This is an investigator initated prospective study assessing  Multifidus Activity Resulting from Restorative Neurostimulation using Novel 18FDG-PET-CT Radiomics. This study will help elucidate the mechanism of action behind restorative multifidus stimulation.

This study has now finished recruitment and Phase 1 data has been presented and submitted for publication.

Relief 1and 2 Studies

 

A prospective global multi-centre registry to evaluate longterm outcome data on patients with spinal cord stimulation.  The main purpose of the study is to compile characteristics of real-world clinical outcomes for Boston Scientific neurostimulation systems for pain in routine clinical practice and to also evaluate the economic value and technical performance these neurostimulation systems.This study is currently recruiting.

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Radiofrequency Denervation for Chronic and Moderate to Severe Low Back Pain (RADICAL) Study

This is a prospective NIHR funded study  that  will recruit 206 patients in pain management centres and spinal clinics across the UK. Patients are randomised to either receive the denervation or a placebo treatment. All patients will be followed up for low back pain, functional disability, general health, and mental well-being outcomes for up to 2 years. This study is currently recruiting.  

Inceptiv Product Surveillance Registry (PSR) Study

 

This is a commercial Product Surveillance Registry to provide continuing evaluation and periodic reporting of safety and effectiveness of Inceptive device for spinal cord stimulation. This study is currently recruiting

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Inceptiv Salvage Therapy Study 

 

This is an ongoing study that will investigate the clinical outcomes of use of closed loop as salvage therapy for patients who have not responded to Spinal cord stimulation. This study is currently recruiting.

 

This is an ongoing clinical effectiveness study that is  is collecting clinical outcomes for patients undergoing spinal cord stimulation for refractory angina as per the Barts RA MDT academic portfolio. This study is currently recruiting.

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Monclonal Antibody (MAB) Clinical Outcome Study

 

This is clinical effectiveness study provide continuing evaluation and periodic reporting of safety and effectiveness of intravenous Eptinezumab for chronic migraine. This study is currently recruiting

 

This is a multi-centre, sham controlled study that is investigating long-term clinical outcomes following SCS for intractable neuropathic spinal pain. This study is currently undergoing regulatory approval.

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