A High Frequency Spinal Cord Stimulation PET-CT Scan Study
A Prospective Single Blind Pilot Study to Investigate the Dynamic Brain Imaging Response to Changes in Frequency Parameters in Patients With Spinal Cord Stimulation With Intractable Neuropathic Pain
1 other identifier
interventional
22
1 country
1
Brief Summary
This study aims to investigate the clinical response to Spinal Cord Stimulation frequency parameters: 40Hz, 4000Hz and 10000Hz and explore the brain imaging changes using PET-CT scans. The response to these stimulator settings on health related quality of life will also be measured using validated questionnaires.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2018
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 9, 2018
CompletedFirst Submitted
Initial submission to the registry
October 22, 2018
CompletedFirst Posted
Study publicly available on registry
October 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2020
CompletedJanuary 9, 2025
January 1, 2025
2 years
October 22, 2018
January 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The change in patient reported back pain levels (Numerical Rating Score)
The Numerical Rating Scale will be used to measure patient reported pain levels. The scale is from 0 (no pain) to 10 (extreme pain).
Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover
Secondary Outcomes (4)
PET/CT Scans
Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover
Oswestry Disability Index (ODI)
Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover
Patients Global Impression of Change (PGIC)
Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover
EQ-5D-5L
Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover
Study Arms (3)
Spinal Cord Stimulation 4000Hz
EXPERIMENTALPatients will trial Spinal Cord Stimulation 4000Hz for 4 weeks. PET/CT scan will be conducted at the end of this period.
Spinal Cord Stimulation 10000Hz
EXPERIMENTALPatients will trial Spinal Cord Stimulation 10,000Hz for 4 weeks. PET/CT scan will be conducted at the end of this period.
Spinal Cord Stimulation 40Hz
ACTIVE COMPARATORPatients will trial Spinal Cord Stimulation 10,000Hz for 4 weeks. PET/CT scan will be conducted at the end of this period.
Interventions
Differential programming of the Boston Scientific Precision™ Plus Spinal Cord Stimulator System
Differential programming of the Boston Scientific Precision™ Plus Spinal Cord Stimulator System
Differential programming of the Boston Scientific Precision™ Plus Spinal Cord Stimulator System
Eligibility Criteria
You may qualify if:
- Patients with intractable lumbar neuropathic pain who are due to receive Percutaneous Spinal Cord Stimulation as part of their standard treatment per NICE HTA guidance 159 at Barts Health NHS Hospitals.
- Patients between 18 and 75 years of age.
- Patients who have given their written informed consent.
- Female patients of childbearing potential must be using adequate contraception (i.e. using oral or IM contraception or an IUCD) and must have a negative urine pregnancy test.
- Patients must be able to communicate in English in order to complete validated questionnaires written in English only.
You may not qualify if:
- Patients with diabetes or any underlying neurological condition.
- Patients known to have a condition that in the investigator's judgement precludes participation in the study.
- Patients who have received an investigational drug or have used an investigational device in the 30 days preceding study entry.
- Patients unable to comply with the study assessments and to complete the questionnaires.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Barts & The London NHS Trustlead
- Boston Scientific Corporationcollaborator
Study Sites (1)
Barts Health NHS Trust
London, EC1A 7BE, United Kingdom
Related Publications (1)
Poply K, Haroon A, Ganeshan B, Nikolic S, Sharma S, Ahmad A, Ellamushi H, Parsai A, Mehta V. Dynamic Brain Imaging Response to Spinal Cord Stimulation Differential Frequencies DiFY SCS-PET Clinical Trial. Neuromodulation. 2023 Jul;26(5):988-998. doi: 10.1016/j.neurom.2022.07.012. Epub 2022 Sep 21.
PMID: 36151010DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vivek Mehta, MD
Barts & The London NHS Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 22, 2018
First Posted
October 23, 2018
Study Start
February 9, 2018
Primary Completion
January 31, 2020
Study Completion
January 31, 2020
Last Updated
January 9, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will not share