Status:
UNKNOWN
Combined Cingulate and Thalamic DBS for Chronic Refractory Chronic Pain
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Chronic Refractory Neuropathic Pain
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Deep brain stimulation (DBS) of the sensory thalamus has been proposed for 40 years to treat medically refractory neuropathic pain, but its efficacy remains partial and unpredictable. Recently, bilate...
Detailed Description
Chronic pain represents a major personal and societal burden, especially for medically resistant patients. Deep brain stimulation (DBS) of the sensory thalamus has been proposed for 40 years to treat ...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- adult patients (age 18-70 years old) suffering from chronic (duration \>1 year) unilateral neuropathic pain
- severe (VAS score \>6/10)
- with high emotional impact (HAD subscores \> 10) considered as resistant to medication specific to neuropathic pain at sufficient doses and durations (including at least antiepileptics and antidepressants) and not sufficiently improved by rTMS and relevant surgical solutions.
- Non inclusion criteria:
- previous history of stroke,
- cognitive impairment (MMSE score \<24),
- DSMIV axis I psychiatric disorder,
- contra-indication to surgery, anesthesia or MRI;
- patient responder to rTMS,
Exclusion
Key Trial Info
Start Date :
April 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 20 2024
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03399942
Start Date
April 6 2018
End Date
March 20 2024
Last Update
July 20 2023
Active Locations (1)
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1
Department of neurosurgery
Nice, France, 06000