Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Boston Scientific Corporation | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Cord Stimulation 4000Hz | Experimental | Patients 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 | Experimental | Patients 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 Comparator | Patients will trial Spinal Cord Stimulation 10,000Hz for 4 weeks. PET/CT scan will be conducted at the end of this period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Cord Stimulation 4000Hz | Device | Differential programming of the Boston Scientific Precision™ Plus Spinal Cord Stimulator System |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, 4-weeks post implant, 4-weeks post randomisation, 4-weeks post crossover |
| Oswestry Disability Index (ODI) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Vivek Mehta, MD | Barts & The London NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barts Health NHS Trust | London | EC1A 7BE | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36151010 | Derived | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
Not provided
Not provided
Single-blind crossover design
Not provided
Not provided
Not provided
| Spinal Cord Stimulation 10000Hz | Device | Differential programming of the Boston Scientific Precision™ Plus Spinal Cord Stimulator System |
|
| Spinal Cord Stimulation 40Hz | Device | Differential programming of the Boston Scientific Precision™ Plus Spinal Cord Stimulator System |
|
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) | 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 | 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 |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |