Motor Cortex Stimulation for Chronic Neuropathic Pain

Not Applicable

• Conditions: Facial Pain; Brachial Plexus Avulsion; Neuropathic Pain; Post-stroke Pain; Phantom Limb Pain of the Upper Extremities
• Interventions: Device: Motor Cortex Stimulation using SJM EonC Stimulator

• Registration Number: NCT01554332
• Lead Sponsor: Abbott Medical Devices

Brief Summary

The purpose of this study is to evaluate the efficacy of cortical stimulation (CS) as an adjunctive treatment for chronic neuropathic pain.

Detailed Description

Prospective, controlled, double blind, randomized, crossover study with endpoint evaluations at the end of each 3-month treatment period.

An interim analysis will be conducted by a blinded committee when approximately half of the patients have finished the study.

Study Timeline

• Study First Submitted: 2012-01-13
• Study First Submitted QC: 2012-03-12
• Study First Posted: 2012-03-14
• Study Start: 2012-10
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-11
• Last Update Posted: 2020-06-12
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Men and women (non-pregnant) age 21-70 years;
• Able to give informed consent in accordance with institutional policies;
• Diagnosis of chronic neuropathic pain according to the DN4 Neuropathic Pain Diagnosis scale (score ≥ 4).
• Documented pain for at least 12 months;
• Documented previous or current treatment for neuropathic pain with medications from at least two of the following groups at adequate doses: antidepressants, anticonvulsants, and/or gabapentinoids;
• VAS scores of at least 6 during baselines #1 and 2.
• Documented clinical diagnosis of neuropathic pain associated with one of the following conditions: facial pain, post-stroke pain, brachial plexus avulsion, or phantom limb pain of the upper extremities.
• In the group with post-stroke pain, only patients with predominant face and upper extremity pain will be included. This will be defined as a difference of ≥ 30% or ≥ 2 points in VAS scores between these regions and lower extremity (in patients who also have pain in the leg).
• No change in current neuropathic pain medication regimen for at least 4 weeks prior to study enrollment.
• Able to comply with all testing and follow-up requirements as defined by the study protocol.
• Must be determined medically stable by surgeon to undergo cortical stimulation surgical procedure.

Exclusion Criteria

• Alcohol, medication, or illegal substance dependence or abuse within last 12 months;
• Trigeminal neuralgia or atypical facial pain.
• Post-stroke pain predominantly in the lower extremity.
• Advanced cardiovascular disease which renders anesthesia and surgery as unsafe as determined by neurosurgeon;
• Clinically relevant abnormality (e.g. tumor) on study MRI;
• Has cardiac pacemaker/defibrillator or other implanted active stimulator;
• Has a medical condition requiring a repetitive MRI body scan;
• Requires chemotherapy for the treatment of malignancy or requiring chronic oral or intravenous, immunosuppressive, or steroid therapy;
• Is unable to comply with study visit schedule and timeline;
• Past ablative or relevant intracranial surgery;
• A female lactating or of child bearing potential, with a positive pregnancy test or not using adequate contraception;
• Other medical conditions likely to require hospitalization within the next year.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active stimulation	Motor Cortex Stimulation using SJM EonC Stimulator	-
Sham stimulation	Motor Cortex Stimulation using SJM EonC Stimulator	-

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale (VAS)	Approximately 7 months	The primary analysis of effectiveness is based on the mean differences in changes from the period-specific baseline in VAS scores when patients are receiving 3 month of active vs. 3 months of sham stimulation on a double-blinded fashion.

Secondary Outcome Measures

Name	Time	Method
Visual Analog Scale, responder	Participants will be followed for approximatley 18 months	defined as a ≥30% or 2 points reduction from baseline in VAS scores
Neuropathic Pain Symptom Inventory (NPSI)	Participants will be followed for approximatley 18 months
Brief Pain Inventory (BPI)	Participants will be followed for approximatley 18 months
Short Form of the McGill Pain Questionnaire(SF-MPQ)	Participants will be followed for approximatley 18 months
Sickness Impact Profile (SIP)	Participants will be followed for approximatley 18 months
Medication Quantification Scale (MQS)	Participants will be followed for approximatley 18 months
SF-36 Health Survey and safety	Participants will be followed for approximatley 18 months
Pain Catastrophizing Scale (PCS)	Participants will be followed for approximatley 18 months
Global Impression of Change (patient and evaluator's version)	Participants will be followed for approximatley 18 months
Device related Adverse Events	Participants will be followed for approximatley 18 months

Trial Locations

Locations (1)

University of São Paulo - Hospital das Clínicas; 🇧🇷 São Paulo, Brazil