Motor Cortex Stimulation for Chronic Neuropathic Pain

NCT01554332 | Unknown

• 1 other identifier: C-11-13
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Motor Cortex Stimulation; Neuropathic pain

Outcome Measures

Primary Outcomes (1)

• 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.

  Approximately 7 months

Secondary Outcomes (10)

• Visual Analog Scale, responder

  Participants will be followed for approximatley 18 months

• 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

Study Arms (2)

Active stimulation

ACTIVE COMPARATOR

Device: Motor Cortex Stimulation using SJM EonC Stimulator

Sham stimulation

SHAM COMPARATOR

Device: Motor Cortex Stimulation using SJM EonC Stimulator

Interventions

Motor Cortex Stimulation using SJM EonC Stimulator DEVICE

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.

Active stimulation; Sham stimulation

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (1)

University of São Paulo - Hospital das Clínicas

São Paulo, Brazil

Location

MeSH Terms

Conditions

Neuralgia; Facial Pain

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Edward Karst

  Abbott Neuromodulation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2012
• First Posted: March 14, 2012
• Study Start: October 1, 2012
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: June 12, 2020

Record last verified: 2020-06

Locations

BR (1)