Clinical trial NCT01554332: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Neuropathic Pain
Facial Pain
Post-stroke Pain
Brachial Plexus Avulsion
Phantom Limb Pain of the Upper Extremities
Keywords: Motor Cortex Stimulation
Neuropathic pain
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2012-03-14
Enrollment: 38
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Visual Analog Scale (VAS)
timeFrame: Approximately 7 months
Secondary outcomes:
measure: Visual Analog Scale, responder
timeFrame: Participants will be followed for approximatley 18 months
measure: Neuropathic Pain Symptom Inventory (NPSI)
timeFrame: Participants will be followed for approximatley 18 months
measure: Brief Pain Inventory (BPI)
timeFrame: Participants will be followed for approximatley 18 months
measure: Short Form of the McGill Pain Questionnaire(SF-MPQ)
timeFrame: Participants will be followed for approximatley 18 months
measure: Sickness Impact Profile (SIP)
timeFrame: Participants will be followed for approximatley 18 months
measure: Medication Quantification Scale (MQS)
timeFrame: Participants will be followed for approximatley 18 months
measure: SF-36 Health Survey and safety
timeFrame: Participants will be followed for approximatley 18 months
measure: Pain Catastrophizing Scale (PCS)
timeFrame: Participants will be followed for approximatley 18 months
measure: Global Impression of Change (patient and evaluator's version)
timeFrame: Participants will be followed for approximatley 18 months
measure: Device related Adverse Events
timeFrame: Participants will be followed for approximatley 18 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo - Hospital das Clínicas
Study officials:
affiliation: Abbott Neuromodulation
name: Edward Karst
role: STUDY_DIRECTOR
References: