Motor Cortex Stimulation for Chronic Neuropathic Pain

Neuropathic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01554332
• Other study ID #: C-11-13
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 2012
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2020
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 38
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Brazil	University of São Paulo - Hospital das Clínicas	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Visual Analog Scale, responder	defined as a =30% or 2 points reduction from baseline in VAS scores	Participants will be followed for approximatley 18 months
Secondary	Neuropathic Pain Symptom Inventory (NPSI)		Participants will be followed for approximatley 18 months
Secondary	Brief Pain Inventory (BPI)		Participants will be followed for approximatley 18 months
Secondary	Short Form of the McGill Pain Questionnaire(SF-MPQ)		Participants will be followed for approximatley 18 months
Secondary	Sickness Impact Profile (SIP)		Participants will be followed for approximatley 18 months
Secondary	Medication Quantification Scale (MQS)		Participants will be followed for approximatley 18 months
Secondary	SF-36 Health Survey and safety		Participants will be followed for approximatley 18 months
Secondary	Pain Catastrophizing Scale (PCS)		Participants will be followed for approximatley 18 months
Secondary	Global Impression of Change (patient and evaluator's version)		Participants will be followed for approximatley 18 months
Secondary	Device related Adverse Events		Participants will be followed for approximatley 18 months