Chronic Refractory Neuropathic Pain
Conditions
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, bilateral DBS of the dorsal anterior cingulate cortex (ACC), a brain region involved in the integration of the affective and cognitive aspects of pain, has been successively proposed to treat few patients suffering from refractory chronic pain, by decreasing the emotional impact of their chronic pain. ACC-DBS could be an alternative or complementary approach to thalamic DBS in these patients, but the consequences of chronic dACC-DBS on cognition and affects have not been studied specifically. The primary objective is to evaluate the feasibility and safety of bilateral ACC-DBS combined with unilateral thalamic DBS in patients suffering from chronic unilateral pain, refractory to medical treatment. Secondary objective will evaluate the efficacy of this combined DBS compared to thalamic DBS only.
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 medically refractory neuropathic pain, but its efficacy remains partial and unpredictable. Recently, bilateral DBS of the dorsal anterior cingulate cortex (ACC), a brain region involved in the integration of the affective, emotional and cognitive aspects of pain, has been successively proposed to treat few patients suffering from refractory chronic pain. In a pilot study, 16 patients treated by ACC-DBS experienced a significant improvement of their quality of life despite a slight decrease of their pain intensity, by improving the affective and emotional impacts of their chronic pain. ACC-DBS could be an alternative or complementary approach to thalamic DBS in these patients. However the consequences of chronic dACC-DBS on cognition and affects have not been studied specifically. The primary objective of this study is to evaluate the feasibility and safety of bilateral ACC-DBS combined with unilateral thalamic DBS in patients suffering from chronic unilateral pain, refractory to medical treatment. Secondary objective will evaluate the efficacy of this combined DBS compared to thalamic DBS only
Interventions
PROCEDUREDeep brain Stimulation of cingulum anterior
The Deep brain Stimulation of cingulum anterior is alternatively ON and OFF while Thalamic stimulation is ON
Sponsors
Centre Hospitalier Universitaire de Nice
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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,
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurence of serious adverse events. | Day 0, Month 1, Month 4, Month 7, Month 10, Month 22 | description of serious adverse events |
| Feasibility of ACC-DBS: success the process of surgical intervention | Day 0 | Feasibility of ACC-DBS will be evaluated by the proportion of patients undergoing with success the process of surgical intervention Safety will be evaluated by neurological examination |
| Feasibility of ACC-DBS : neurological success of the process of chronic stimulation | Day 0, Month 1, Month 4, Month 7, Month 10, Month 22 | neurological success of the process of chronic stimulation will be evaluated by the neurological examination |
| Feasibility of ACC-DBS : psychiatric success of the process of chronic stimulation | Day 0, Month 1, Month 4, Month 7, Month 10, Month 22 | psychiatric success of the process of chronic stimulation will be evaluated by the psychiatric assessment |
| Feasibility of ACC-DBS : cognitive success of the process of chronic stimulation | Day 0, Month 1, Month 4, Month 7, Month 10, Month 22 | cognitive success of the process of chronic stimulation will be evaluated by the cognitive assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of ACC-DBS : change of pain intensity | Day 0, Month 1, Month 4, Month 7, Month 10, Month 22 | Efficacy of ACC-DBS will be evaluated by pain intensity (VAS) |
| Efficacy of ACC-DBS : change of quality of life by SF-36 | Day 0, Month 1, Month 4, Month 7, Month 10, Month 22 | Efficacy of ACC-DBS will be evaluated by quality of life (SF36). |
| Efficacy of ACC-DBS : change of quality of life by EQ-5D | Day 0, Month 1, Month 4, Month 7, Month 10, Month 22 | Efficacy of ACC-DBS will be evaluated by quality of life (EQ5D). |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORDenys FONTAINE
fontaine.d@chu-nice.fr
Outcome results
None listed