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Motor Cortex Stimulation for Chronic Neuropathic Pain

Primary Purpose

Neuropathic Pain, Facial Pain, Post-stroke Pain

Status

Unknown status

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

Motor Cortex Stimulation using SJM EonC Stimulator

About this trial

This is an interventional treatment trial for Neuropathic Pain focused on measuring Motor Cortex Stimulation, Neuropathic pain

Eligibility Criteria

21 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

University of São Paulo - Hospital das Clínicas

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active stimulation

Sham stimulation

Arm Description

Outcomes

Primary Outcome Measures

Visual Analog Scale (VAS)

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

Visual Analog Scale, responder

defined as a ≥30% or 2 points reduction from baseline in VAS scores

Neuropathic Pain Symptom Inventory (NPSI)

Brief Pain Inventory (BPI)

Short Form of the McGill Pain Questionnaire(SF-MPQ)

Sickness Impact Profile (SIP)

Medication Quantification Scale (MQS)

SF-36 Health Survey and safety

Pain Catastrophizing Scale (PCS)

Global Impression of Change (patient and evaluator's version)

Device related Adverse Events

Full Information

NCT ID

NCT01554332

First Posted

January 13, 2012

Last Updated

June 11, 2020

Sponsor

Abbott Medical Devices

1. Study Identification

Unique Protocol Identification Number

NCT01554332

Brief Title

Motor Cortex Stimulation for Chronic Neuropathic Pain

Official Title

A Clinical Evaluation for the Management of Patients With Chronic Neuropathic Pain With Cortical Stimulation

Study Type

Interventional

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 2012 (undefined)

Primary Completion Date

December 31, 2020 (Anticipated)

Study Completion Date

December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Abbott Medical Devices

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neuropathic Pain, Facial Pain, Post-stroke Pain, Brachial Plexus Avulsion, Phantom Limb Pain of the Upper Extremities

Keywords

Motor Cortex Stimulation, Neuropathic pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

38 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Active stimulation

Arm Type

Active Comparator

Arm Title

Sham stimulation

Arm Type

Sham Comparator

Intervention Type

Device

Intervention Name(s)

Motor Cortex Stimulation using SJM EonC Stimulator

Intervention Description

Patients will be randomized to receive either active stimulation the first 3 months followed by a one-month washout, followed by Sham Stimulation the next 3 months, vs. the reverse order of treatment, followed by single blind stimulation, and an open label phase.

Primary Outcome Measure Information:

Title

Visual Analog Scale (VAS)

Description

Time Frame

Approximately 7 months

Secondary Outcome Measure Information:

Title

Visual Analog Scale, responder

Description

defined as a ≥30% or 2 points reduction from baseline in VAS scores

Time Frame