Electroencephalographic Changes in Spinal Cord Stimulation

Sponsor

The Leeds Teaching Hospitals NHS Trust (Other)

Overall Status

Unknown status

CT.gov ID

NCT03582059

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Pain Management	Procedure: High Frequency Spinal cord stimulation Procedure: Burst Frequency Spinal cord stimulation	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

Single blind, randomized cross over study at a single centreSingle blind, randomized cross over study at a single centre

Masking:

Single (Participant)

Primary Purpose:

Other

Official Title:

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).

Actual Study Start Date :

Apr 1, 2017

Actual Primary Completion Date :

Oct 16, 2018

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Electrencephalographic patterns generated [60 mins]
Pain measured according to pain vigilance and awareness questionnaire (PVAQ)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

1. 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:

1. 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.

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leeds Teaching Hospitals NHS Trust	Leeds		United Kingdom

Sponsors and Collaborators

The Leeds Teaching Hospitals NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The Leeds Teaching Hospitals NHS Trust

ClinicalTrials.gov Identifier:

NCT03582059

Other Study ID Numbers:

PM16/84656

First Posted:

Jul 10, 2018

Last Update Posted:

Aug 13, 2019

Last Verified:

Aug 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Study Results

No Results Posted as of Aug 13, 2019