Status:
COMPLETED
Posterior-superior Insula Deep Brain Stimulation in Refractory Peripheral Neuropathic Pain Patients
Lead Sponsor:
University of Sao Paulo
Conditions:
Neuropathic Pain
Neuropathy;Peripheral
Eligibility:
All Genders
21-70 years
Phase:
NA
Brief Summary
This study evaluates the long term pain relief after deep brain stimulation on posterior-superior insula (PSI) in patients with refractory peripheral neuropathic pain who responded to real but not to ...
Detailed Description
This study has two phases: Study I) This study is an extension of 690.455/NCT01932905, in which non invasive stimulation of the posterior-superior insula (PSI) was performed by deep repetitive transc...
Eligibility Criteria
Inclusion
- Men and non-pregnant women aged 21-70 years.
- Ability to give informed consent in accordance with institutional policy.
- Have a diagnosis of neuropathic pain according to Douleur neuropathique 4 questions (DN4).
- Patients with predominant pain on the face and upper extremities in relation to the lower limbs. In this study, predominance will be defined as the difference of ≥ 30% or ≥ 2 points on the VAS scale between upper limb / face pain and lower limb pain.
- Pain lasting more than 12 months.
- Documented resistance to clinical treatment, defined in this study as persistence of pain after a minimum of 2 appropriate pharmacological treatments, including at least one antidepressant / anticonvulsant and / or gabapentins. Adequacy of treatments will be defined by the use of drugs in doses considered adequate in the literature or below the threshold of side effects.
- Visual analog scale (EVA) scores of at least four during initial assessments.
- No change in the analgesic medication regimen for chronic neuropathic pain during the 4 weeks preceding entry into the study.
- Ability to comply with the tests and follow-up defined by the study protocol;
- Absence of routine contraindications to the surgical procedure (eg Coagulopathies, blood dyscrasias). These will be evaluated by members of the neurosurgical team responsible for the study
Exclusion
- Alcohol abuse, medication, or addiction to illicit substances in the last 12 months.
- Diagnosis of idiopathic trigeminal neuralgia or atypical facial pain.
- Advanced cardiovascular disease stage that makes anesthesia and surgery unsafe, as determined by the neurosurgeon / clinical team.
- Clinically relevant lesions (tumor, for example) on preoperative magnetic resonance imaging.
- Cardiac pacemaker / implanted defibrillator or other active stimulators.
- Medical condition that requires repeated resonances.
- Patients using chemotherapy for the treatment of malignant tumors or who need chronic oral or intravenous treatment with immunosuppressants or steroids.
- Patients unable to comply with the study visit schedule.
- Brain ablative surgery or previous neurosurgery that prevents or increases the risk of implantation of the electrodes.
- Patients of childbearing potential or infants with a positive pregnancy test or without the use of adequate contraception.
- Other medical conditions that require probable hospitalization during the study.
- History of epilepsy or status epilepticus.
- Chronic infection.
- Diagnosis of fibromyalgia.
- Plans for using diathermy in the future.
- Have any intracranial metal implant
- Current participation in another device investigation study or experimentation with drugs or surgery of any kind.
Key Trial Info
Start Date :
January 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2021
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04279548
Start Date
January 1 2018
End Date
July 1 2021
Last Update
January 28 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil, 05403-900