Motor Cortex Stimulation for Chronic Neuropathic Pain - Full Text View

Purpose

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

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

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	A Clinical Evaluation for the Management of Patients With Chronic Neuropathic Pain With Cortical Stimulation

Further study details as provided by St. Jude Medical:

Primary Outcome Measures:

Visual Analog Scale (VAS) [ Time Frame: Approximately 7 months ] [ Designated as safety issue: No ]
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 [ Time Frame: Participants will be followed for approximatley 18 months ] [ Designated as safety issue: No ]
defined as a ≥30% or 2 points reduction from baseline in VAS scores
Neuropathic Pain Symptom Inventory (NPSI) [ Time Frame: Participants will be followed for approximatley 18 months ] [ Designated as safety issue: No ]
Brief Pain Inventory (BPI) [ Time Frame: Participants will be followed for approximatley 18 months ] [ Designated as safety issue: No ]
Short Form of the McGill Pain Questionnaire(SF-MPQ) [ Time Frame: Participants will be followed for approximatley 18 months ] [ Designated as safety issue: No ]
Sickness Impact Profile (SIP) [ Time Frame: Participants will be followed for approximatley 18 months ] [ Designated as safety issue: No ]
Medication Quantification Scale (MQS) [ Time Frame: Participants will be followed for approximatley 18 months ] [ Designated as safety issue: No ]
SF-36 Health Survey and safety [ Time Frame: Participants will be followed for approximatley 18 months ] [ Designated as safety issue: No ]
Pain Catastrophizing Scale (PCS) [ Time Frame: Participants will be followed for approximatley 18 months ] [ Designated as safety issue: No ]
Global Impression of Change (patient and evaluator's version) [ Time Frame: Participants will be followed for approximatley 18 months ] [ Designated as safety issue: No ]
Device related Adverse Events [ Time Frame: Participants will be followed for approximatley 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	44
Study Start Date:	October 2012
Estimated Study Completion Date:	September 2015
Estimated Primary Completion Date:	September 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Active stimulation	Device: Motor Cortex Stimulation using SJM EonC Stimulator 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.
Sham Comparator: Sham stimulation	Device: Motor Cortex Stimulation using SJM EonC Stimulator 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.

Detailed Description:

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

Eligibility

Ages Eligible for Study:	21 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554332

Contacts

Contact: Manoel Jacobsen Teixeira, MD

(11)3069-6440

manoeljteixeira@aol.com

Locations

Brazil
University of São Paulo - Hospital das Clínicas	Recruiting
São Paulo, Brazil
Contact: Manoel Jacobsen Teixeira, MD (11) 3069-6440 manoeljteixeira@aol.com
Sub-Investigator: Erich Talamoni Fonoff, MD
Sub-Investigator: Daniel Ciampi de Andrade, MD
Sub-Investigator: Clement Hamani, MD

Sponsors and Collaborators

St. Jude Medical

Investigators

Study Director:

DeLea Peichel

St. Jude Medical Neuromodulation Division

More Information

No publications provided

Responsible Party:	St. Jude Medical
ClinicalTrials.gov Identifier:	NCT01554332 History of Changes
Other Study ID Numbers:	C-11-13
Study First Received:	January 13, 2012
Last Updated:	October 9, 2012
Health Authority:	Brazil: National Committee of Ethics in Research

Keywords provided by St. Jude Medical:

Motor Cortex Stimulation
Neuropathic pain

Additional relevant MeSH terms:

Facial Pain
Neuralgia
Phantom Limb
Stroke
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases

Neuromuscular Diseases
Perceptual Disorders
Neurobehavioral Manifestations
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013