Trials / Unknown
UnknownNCT01554332
Motor Cortex Stimulation for Chronic Neuropathic Pain
A Clinical Evaluation for the Management of Patients With Chronic Neuropathic Pain With Cortical Stimulation
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 38 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 21 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Neuropathic Pain
- Facial Pain
- Post-stroke Pain
- Brachial Plexus Avulsion
- Phantom Limb Pain of the Upper Extremities
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2012-10-01
- Primary completion
- 2020-12-31
- Completion
- 2020-12-31
- First posted
- 2012-03-14
- Last updated
- 2020-06-12
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT01554332. Inclusion in this directory is not an endorsement.