Brachial Plexus Avulsion, Facial Pain, Neuropathic Pain, Phantom Limb Pain of the Upper Extremities, Post-stroke Pain
Conditions
Keywords
Motor Cortex Stimulation, Neuropathic pain
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.
Interventions
DEVICEMotor 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.
Sponsors
Abbott Medical Devices
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 |
| 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 | — |
| Medication Quantification Scale (MQS) | Participants will be followed for approximatley 18 months | — |
Countries
Brazil
Outcome results
None listed