A Feasibility Study to Investigate the Dynamic Brain Imaging in Patients Following SCS- DRG

NCT04508127 | Completed FDA Device

• 1 other identifier: 15.LO.1667
• Study Type: observational
• Target: 10
• Locations: 0 countries
• Sites: N/A

Brief Summary

Targeted SCS is a standard and safe interventional pain procedure that is offered to patients with intractable neuropathic pain for their symptomatic relief. The known and reported complications include technical failure to perform the procedure, failure to gain symptomatic relief, trauma to nerve, and infection. These risks are very low in incidence and part of any interventional pain procedure in the spine. PET-CT scan involves insertion of a cannula and administration of a dye (FDG) as a contrast in a patient who has been fasted for at least 6 hours. The procedure is lengthy and can take up to 2 to 3 hours. This includes a 30-60 minute resting time following the injection of contrast. The actual scan itself takes up to 30 minutes. There is a small chance of pain and redness at the injection site. Allergic reaction to the radio-contrast is rare and is usually mild. Patients with known allergy to FDG will not be recruited in the study. Some patients can feel claustrophobic at the time of the scan which can make them feel anxious. The PET-CT scan involves radiation with associated risks as detailed in the previous section. All these risks will be explained to the patients at the time of the informed consent.

Conditions

Neuropathic Pain

Keywords

DRG; SCS; PET Scans

Outcome Measures

Primary Outcomes (5)

• The PET-CT and metabolic activity/ mapping at baseline.

  Determine the presence of a quantifiable alteration in central processing using PET-CT and metabolic activity/ mapping at baseline

  baseline

• The changes of PET-CT and metabolic activity/ mapping at 2 weeks.

  Determine the presence of a quantifiable alteration in central processing using PET-CT and metabolic activity/ mapping at 2 weeks post treatment.

  2 weeks

• The changes PET-CT and metabolic activity/ mapping at 4 weeks.

  Determine the presence of a quantifiable alteration in central processing using PET-CT and metabolic activity/ mapping at 4 weeks post treatment.

  4 weeks

• The changes PET-CT and metabolic activity/ mapping at 3 months.

  Determine the presence of a quantifiable alteration in central processing using PET-CT and metabolic activity/ mapping at 3 months post treatment.

  3 months

• The changes PET-CT and metabolic activity/ mapping at 6 months.

  Determine the presence of a quantifiable alteration in central processing using PET-CT and metabolic activity/ mapping at 6 months post treatment.

  6 months

Secondary Outcomes (30)

• Pain and satisfaction to treatment assessed using Numerical Rating Scale (NRS) questionnaires at baseline

  Baseline

• Pain and satisfaction to treatment assessed using Numerical Rating Scale (NRS) questionnaires at 4 weeks

  4 weeks

• Pain and satisfaction to treatment assessed using Numerical Rating Scale (NRS) questionnaires at 3 months

  3 months

• Pain and satisfaction to treatment assessed using Numerical Rating Scale (NRS) questionnaires at 6 months

  6 months

• Pain and satisfaction to treatment assessed using Numerical Rating Scale (NRS) questionnaires at 12 months

  12 months

Study Arms (1)

Active Procedure

The patients will receive targeted Percutaneous Spinal Cord Stimulation at suitable DRG with Axium SCS system as part of their standard treatment for lumbar pain. The lead placement will happen in 2 stages. First stage involves placement of leads and an externalised device and is a trial stage. Patient deemed to have a good response to first stage will proceed to the second stage to have the permanent implant. Again this is part of our standard care. Normally our drop out rate after first stage is less than 10% and these patients will not have subsequent tests including PET-CT scan and questionnaires.

Device: Spinal cord stimulation

Interventions

Spinal cord stimulation DEVICE

Active Procedure

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be selected from the Pain multi-disciplinary team meetings at Barts Health NHS trust. Patients will be seen by a team of neurosurgeons, pain consultants and psychologist to assess their suitability for targeted SCS.

You may qualify if:

• Male and female patients between the age of 18-80 years who has intractable neuropathic pain.
• Minimum baseline pain rating of 50mm on a 100mm NRS in the back and/or leg
• Chronic pain of at least 6 months
• Subject satisfies standard criteria in the study centre for SCS implantation and the NICE 159 criteria for management of intractable neuropathic pain.
• Patients who have given their written informed consent.
• Patient is able and willing to comply with study procedures and follow up schedule.

You may not qualify if:

• Female patients of childbearing age who is or plans on becoming pregnant during the course of the study
• Patients who have undergone radiofrequency or injection therapy at or on a target neural structure (DRG) during the past 90 days
• Patient deemed unsuitable to have targeted SCS as assessed by the MDT.
• 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 proceeding to study entry
• Patients who are needle phobic or claustrophobic.
• Known allergic reaction to radio-contrast.
• Patients who are at high risk of a radiation hazard (previous radiation induced injury or cancer or previously received high radiation doses).

Sponsors & Collaborators

• Barts & The London NHS Trust: lead

MeSH Terms

Conditions

Neuralgia

Interventions

Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2019
• First Posted: August 11, 2020
• Study Start: March 1, 2016
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: August 11, 2020

Record last verified: 2018-11