A High Frequency Spinal Cord Stimulation PET-CT Scan Study

January 8, 2025 updated by: Barts & The London NHS Trust

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Spinal cord stimulation (SCS) is a treatment option for people suffering with chronic neuropathic back and leg pain. Conventionally, patients receiving SCS are provided with tonic stimulation parameters, where the frequency of electrical pulses is set at 40-60Hz. The major side effect of tonic SCS parameters is the onset of paraesthesia, a tingling or pins and needles sensation within the target region, which can cause discomfort for some patients. However, newer methods include high-frequency stimulation (HF) which is able to provide paraesthesia free stimulation, ultimately providing better patient tolerability. HF stimulation is widely offered to patients with SCS as part of routine clinical practice. However, the effect on pathways in the brain remains to be characterised. This study therefore aims to investigate the clinical response to three frequency parameters 40Hz, 4000Hz and 10000Hz and also 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.

20 patients who are deemed suitable for SCS as part of NICE guidelines 159 pathway will be recruited for the study. All patients will have a baseline PET-CT scan and undergo first stage of SCS where they will be offered tonic 40Hz settings as part of trial stimulation. If successful (>50% improvement in pain scores) patients will be offered second stage and continue to receive 40Hz stimulation for 4 weeks. After a second PET-CT scan they are randomised to receive either 4000Hz or 10000Hz stimulation for 4 more weeks, then cross-over treatment for another 4 weeks. PET-CT scans will be performed between each level of stimulation and at the end of the study (4 in total).

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, EC1A 7BE
        • Barts Health NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Spinal Cord Stimulation 4000Hz
Patients will trial Spinal Cord Stimulation 4000Hz for 4 weeks. PET/CT scan will be conducted at the end of this period.
Device: Spinal Cord Stimulation 4000Hz
Differential programming of the Boston Scientific Precision™ Plus Spinal Cord Stimulator System
Experimental: Spinal Cord Stimulation 10000Hz
Patients will trial Spinal Cord Stimulation 10,000Hz for 4 weeks. PET/CT scan will be conducted at the end of this period.
Device: Spinal Cord Stimulation 10000Hz
Differential programming of the Boston Scientific Precision™ Plus Spinal Cord Stimulator System
Active Comparator: Spinal Cord Stimulation 40Hz
Patients will trial Spinal Cord Stimulation 10,000Hz for 4 weeks. PET/CT scan will be conducted at the end of this period.
Device: Spinal Cord Stimulation 40Hz
Differential programming of the Boston Scientific Precision™ Plus Spinal Cord Stimulator System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change in patient reported back pain levels (Numerical Rating Score)
Time Frame: Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
PET/CT Scans
Time Frame: Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover
Investigate the changes in the brain following Spinal Cord Simulator (SCS) programmed with the various settings (frequency: 40Hz, 4000Hz and 10000Hz) using imaging technology (PET-CT scan)
Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover
Oswestry Disability Index (ODI)
Time Frame: Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover
A low back pain functional disability outcome tool. The final score ranges from 0-100. A score of 0-20 reflects minimal disability, 21-40 moderate disability, 41-60 severe disability, 61-80 crippled, and 81-100 bed-bound.
Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover
Patients Global Impression of Change (PGIC)
Time Frame: Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover
A scale to measure the patient's belief about the efficacy of treatment. The scale is from 1 (no change) to 7 (a great deal better). Higher PGIC scores are associated with greater improvement in pain.
Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover
EQ-5D-5L
Time Frame: Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover
A standardised measure of health status. A summary index with a maximum score of 1 can be derived from five questions. The maximum score of 1 indicates the best health state. There is also a visual analogue scale (0-100) to indicate the general health status with 100 indicating the best health status.
Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barts & The London NHS Trust

Collaborators

Boston Scientific Corporation

Investigators

  • Principal Investigator: Vivek Mehta, MD, Barts & The London NHS Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 9, 2018

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

January 31, 2020

Study Registration Dates

First Submitted

October 22, 2018

First Submitted That Met QC Criteria

October 22, 2018

First Posted (Actual)

October 23, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 8, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 011768

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Neuropathic Pain

Clinical Trials on Spinal Cord Stimulation 4000Hz

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe