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Neuropathic PainNCT03716557

A High Frequency Spinal Cord Stimulation PET-CT Scan Study

A study testing Spinal Cord Stimulation 4000Hz, Spinal Cord Stimulation 10000Hz and Spinal Cord Stimulation 40Hz in people with Neuropathic Pain, run by Barts & The London NHS Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Neuropathic Pain
What is being tested?
Spinal Cord Stimulation 4000Hz, Spinal Cord Stimulation 10000Hz and Spinal Cord Stimulation 40Hz
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
22 participants
Where
1 siteUnited Kingdom
Study dates
9 Feb 2018to 31 Jan 2020
Phase
Interventional
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 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • Barts Health NHS Trust

    London, EC1A 7BE

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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).

Being tested
Spinal Cord Stimulation 4000Hz, Spinal Cord Stimulation 10000Hz, Spinal Cord Stimulation 40Hz
Keywords
spinal cord stimulation, high frequency stimulation, paraesthesia-free
Medical subject headings
Neuralgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spinal Cord Stimulation 4000HzDevice

    Differential programming of the Boston Scientific Precision™ Plus Spinal Cord Stimulator System

  • Spinal Cord Stimulation 10000HzDevice

    Differential programming of the Boston Scientific Precision™ Plus Spinal Cord Stimulator System

  • Spinal Cord Stimulation 40HzDevice

    Differential programming of the Boston Scientific Precision™ Plus Spinal Cord Stimulator System

Study groups in NCT03716557
Study groupRoleWhat they receive
Spinal Cord Stimulation 4000HzExperimentalPatients will trial Spinal Cord Stimulation 4000Hz for 4 weeks. PET/CT scan will be conducted at the end of this period.
Receives: Device: Spinal Cord Stimulation 4000Hz
Spinal Cord Stimulation 10000HzExperimentalPatients will trial Spinal Cord Stimulation 10,000Hz for 4 weeks. PET/CT scan will be conducted at the end of this period.
Receives: Device: Spinal Cord Stimulation 10000Hz
Spinal Cord Stimulation 40HzActive comparatorPatients will trial Spinal Cord Stimulation 10,000Hz for 4 weeks. PET/CT scan will be conducted at the end of this period.
Receives: Device: Spinal Cord Stimulation 40Hz

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover

Secondary outcomes (4)

  1. PET/CT Scans

    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)

    Measured: Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover

  2. Oswestry Disability Index (ODI)

    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.

    Measured: Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover

  3. Patients Global Impression of Change (PGIC)

    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.

    Measured: Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover

  4. EQ-5D-5L

    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.

    Measured: Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2018
  2. Study start9 Feb 2018
  3. Primary completion31 Jan 2020
  4. Study completion31 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Model description
Single-blind crossover design
Masking
Single blind
Who is masked
Participant
Enrolment
22 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03716557
Sponsor's protocol ID
011768
Status last verified
Jan 2025
First submitted
22 Oct 2018
Last updated
9 Jan 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36151010

Questions about this trial

What is this clinical trial studying?

A study testing Spinal Cord Stimulation 4000Hz, Spinal Cord Stimulation 10000Hz and Spinal Cord Stimulation 40Hz in people with Neuropathic Pain, run by Barts & The London NHS Trust at 1 site in United Kingdom.

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 5 inclusion and 4 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 9 Jan 2025. 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 Kingdom. 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?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03716557, which also lists 1 linked publication.

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 9 Jan 2025.

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