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A High Frequency Spinal Cord Stimulation PET-CT Scan Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03716557
Recruitment Status : Recruiting
First Posted : October 23, 2018
Last Update Posted : November 15, 2019
Sponsor:
Collaborator:
Boston Scientific Corporation
Information provided by (Responsible Party):
Barts & The London NHS Trust

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.

Condition or disease Intervention/treatment Phase
Neuropathic Pain Device: Spinal Cord Stimulation 4000Hz Device: Spinal Cord Stimulation 10000Hz Device: Spinal Cord Stimulation 40Hz Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Single-blind crossover design
Masking: Single (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : February 9, 2018
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: CT Scans

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




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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)

  2. 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.

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03716557


Contacts
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Contact: Vivek Mehta, MD 02037658878 vivek.mehta@nhs.net
Contact: Kavita Poply, MD kavita.poply2@nhs.net

Locations
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United Kingdom
Barts Health NHS Trust Recruiting
London, United Kingdom, EC1A 7BE
Contact: Alia Ahmad, MSc    0203 765 8878    alia.ahmad1@nhs.net   
Contact: Vivek Mehta, MD    0203 765 8876    vivek.mehta@nhs.net   
Sponsors and Collaborators
Barts & The London NHS Trust
Boston Scientific Corporation
Investigators
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Principal Investigator: Vivek Mehta, MD Barts & The London NHS Trust

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Responsible Party: Barts & The London NHS Trust
ClinicalTrials.gov Identifier: NCT03716557    
Other Study ID Numbers: 011768
First Posted: October 23, 2018    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Barts & The London NHS Trust:
spinal cord stimulation
high frequency stimulation
paraesthesia-free
Additional relevant MeSH terms:
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Neuralgia
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Pain
Neurologic Manifestations
Signs and Symptoms