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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01554332
Other study ID # C-11-13
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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