Electroencephalographic Changes in Spinal Cord Stimulation

A Prospective, Double Blind, Cross Over, Pilot Study to Evaluate EEG Changes in Patients' Undergoing Spinal Cord Stimulation(SCS) With High Frequency and Burst Frequency for Failed Back Surgery Syndrome(FBSS).

Spinal cord stimulation by means of an electrode in the back is used to treat patients with persistent chronic pain after back surgery. Based on the stimulation patterns, there are mainly three different technologies available - conventional, burst frequency and the high frequency. It is known that the traditional frequency works through the lateral system of pain pathways in the spinal cord to cause pain reduction. Electroencephalographic(tracing of brain activity) recording of patients using burst have shown an additional effect on an adjacent medial pain pathway which decreases the attention to pain. We want to therefore find out if high frequency stimulation also has an effect on the same pathways. 20 patients who have persistent neuropathic chronic pain after previous spinal surgery, would be eligible to have this treatment as part of their normal care. They will be randomly chosen to undergo a 2 week cycle of high frequency and 2 weeks of burst stimulation. We will record EEG's, pain scores and scores measuring attention to pain and compare findings. All patients will be recruited at the Leeds Pain and Neuromodulaton centre and the EEg analysis will be done by a research team based in Belgium. We hope that the study will improve our understanding of how different stimuation waveforms used for spinal cord stimulation work. We hope to have recruited all 20 patients in a 12 month period.

Study Overview

• Status: Unknown
• Conditions: Pain Management
• Intervention / Treatment: Procedure: High Frequency Spinal cord stimulation; Procedure: Burst Frequency Spinal cord stimulation

• Study Type: Interventional
• Enrollment (Actual): 18
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Leeds, United Kingdom
    • Leeds Teaching Hospitals NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• I. Patient is 18 years of age or older and has given written informed consent. II. Has persistent chronic predominant low back pain of neuropathic origin, with or with out radiculopathy, for a minimum of 6 months as per NICE Tag 0159. III. Patient has had previous spinal surgery at least > 6 months ago. IV. Numerical rating scale Scale (NRS) back pain score of at least 5 at baseline V. Confirmation of pain from neuropathic origin as per NICE guidance TAG 0159 VI. Total daily dose of opioids equivalent to ≤120mg of Morphine VII. In the investigators opinion the patient is a suitable candidate for SCS. VIII. Patient is willing to comply with the requirements of the study

Exclusion Criteria:

• I. Patient has mechanical spine instability based on flexion/extension testing of lumbar spine (documented in the last 6 months) II. Patient is pregnant, or pregnancy is suspected or planned within the first six months of the study timeframe.

III. Patient has a cardiac pacemaker, automatic defibrillator, or any other implanted device, which will make the trial impossible. IV. Allergy to device components or drugs to be used in the intended procedure. V. Medical co-morbidities that preclude surgical intervention. VI. Patient is incapable of understanding or responding to the study questionnaires VII. Patient is incapable of understanding or operating the patient programmer handset.

VIII. Patient is morbidly obese (BMI ≥ 40). IX. Patient is simultaneously participating in another device or drug study within the last 30 days.

X. Patient is on more than 120 mg of morphine a day. XI. Patient has a spinal fracture, tumour or infection. XII. Clinical evidence of cauda equina syndrome. XIII. Progressive neurologic deficit. XIV. Patient has epilepsy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Patient group meeting inclusion criteria group 1; Patients meeting the inclusion criteria in the first 10 days of entering trial and are randomised to first intervention.	Procedure: High Frequency Spinal cord stimulation; An electrode will be implanted into the patients back. A defined stimulation patter will be applied. The patient will be randomised to received 7-10 days of high frequency stimulation.; Procedure: Burst Frequency Spinal cord stimulation; An electrode will be implanted into the patients back. A defined stimulation patter will be applied. The patient will be randomised to received 7-10 days of burst frequency stimulation.
Other: Patient group meeting inclusion criteria group 2; Patient group meeting inclusion criteria after 10 days and are allocated second intervention.	Procedure: High Frequency Spinal cord stimulation; An electrode will be implanted into the patients back. A defined stimulation patter will be applied. The patient will be randomised to received 7-10 days of high frequency stimulation.; Procedure: Burst Frequency Spinal cord stimulation; An electrode will be implanted into the patients back. A defined stimulation patter will be applied. The patient will be randomised to received 7-10 days of burst frequency stimulation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrencephalographic patterns generated	Pain measured according to pain vigilance and awareness questionnaire (PVAQ)	60 mins

Collaborators and Investigators

• Sponsor: The Leeds Teaching Hospitals NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): October 16, 2018
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: September 23, 2016
• First Submitted That Met QC Criteria: June 27, 2018
• First Posted (Actual): July 10, 2018

Study Record Updates

• Last Update Posted (Actual): August 13, 2019
• Last Update Submitted That Met QC Criteria: August 12, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: PM16/84656

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