Burst Spinal Cord Stimulation for Neuropathic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-09-30

Brief Summary

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Recently a novel stimulation design was developed, called burst stimulation. In a non-placebo controlled pilot study burst stimulation seemed superior to tonic stimulation over a period extending more than 2 years, and even though an incidental finding, this design seemed capable of suppressing pain without mandatory induction of paresthesias. This permits for the first time to scientifically prove that spinal cord stimulation is better than placebo stimulation. A study was therefore initiated to find out whether spinal cord stimulation is indeed capable of suppressing neuropathic limb pain in a placebo controlled way.

Detailed Description

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Patients receive three type of stimulation (burst, tonic and sham). We want to compare these different stimulation protocol to verify which one is the one the patient prefer the most and have the least side-effects (paresthesia)

Conditions

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Neuropathic Pain

Keywords

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tonic, burst and placebo stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Tonic

5 hz stimulation at an amplitude that the patient find bearable (+/- 1.5 mA)

Group Type EXPERIMENTAL

dorsal column stimulator

Intervention Type PROCEDURE

test different settings of stimulation

Sham

no stimulation, patient receive a sham stimulation (actually the IPG is not running)

Group Type EXPERIMENTAL

dorsal column stimulator

Intervention Type PROCEDURE

test different settings of stimulation

burst

500 hz burst at 5 hz stimulation

Group Type EXPERIMENTAL

dorsal column stimulator

Intervention Type PROCEDURE

test different settings of stimulation

Interventions

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dorsal column stimulator

test different settings of stimulation

Intervention Type PROCEDURE

Other Intervention Names

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IPG is used by ST Jude medical together with an 88 lamitrode lead

Eligibility Criteria

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Inclusion Criteria

* Patients able to provide informed consent to participate in the study;
* Patient is between the age of 18 and 75;
* Patient has Failed Back Surgery Syndrome;
* Patient has a simulator implanted at the dorsal column spinal cord powered by an EON/EON Mini® internal pulse generator.
* Patient medication has remained stable for at least 4 weeks prior to baseline data collection;
* Patient agrees not to add or increase medication throughout the randomization trial period of the study;
* Patient is willing to cooperate with the study requirements including compliance with the treatment regimen and completion of all office visits.

Exclusion Criteria

A patient will be excluded from participation in this study if they meet any one of the following criteria:

* Patient has current evidence of any psychiatric disorder, as documented by the DSM-IV-TR criteria with psychotic characteristics;
* Patient has a history of life-threatening severe illness or is suffering from severe chronic disease other than the indication for the study;
* Patient has history of substance abuse or substance dependency in the past 6 months prior to baseline data collection;
* Patient currently participating in another clinical study;
* Patient with demand-type cardiac pacemakers, an infusion pump or any other implantable neurostimulator device except for the spinal cord stimulator under study;
* Patient is not willing to maintain current medication regimen;
* Female candidates of child bearing potential who are pregnant (confirmed by positive urine/blood pregnancy test), not using adequate contraception as determined by the investigator, or nursing (lactating) a child.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Sven Vanneste

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sven Vanneste, PhD

Role: PRINCIPAL_INVESTIGATOR

Universiteit Antwerpen

Locations

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University Hospital Antwerp

Edegem, , Belgium

Site Status

Countries

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Belgium

References

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O'Connell NE, Ferraro MC, Gibson W, Rice AS, Vase L, Coyle D, Eccleston C. Implanted spinal neuromodulation interventions for chronic pain in adults. Cochrane Database Syst Rev. 2021 Dec 2;12(12):CD013756. doi: 10.1002/14651858.CD013756.pub2.

Reference Type DERIVED

PMID: 34854473 (View on PubMed)

Other Identifiers

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