Combined Cingulate and Thalamic DBS for Chronic Refractory Chronic Pain

Not Applicable

Active, not recruiting

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

Recruitment & Eligibility

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:

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
DBS-ACC ON	Deep brain Stimulation of cingulum anterior	Start of stimulation of the DBS-ACC: On the first period, between M4 and M7, the DBS-ACC is ON and the second period, between M7 and M10 is OFF
DBS-ACC OFF	Deep brain Stimulation of cingulum anterior	Start of stimulation of the DBS-ACC: On the first period, between M4 and M7, the DBS-ACC is OFF and the second period, between M7 and M10 is ON

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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).
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 (McGill Pain Questionnaire)
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).