Clinical trial NCT03399942: Combined Cingulate and Thalamic DBS for Chronic Refractory Chronic Pain
Official title: Treatment of Chronic Refractory Pain by Combined Deep Brain Stimulation of the Anterior Cingulum and Sensory Thalamus: a Feasibility and Safety Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Refractory Neuropathic Pain
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2018-01-17
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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

Eligibility criteria: 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,

Primary outcomes:
measure: Occurence of serious adverse events.
timeFrame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
measure: Feasibility of ACC-DBS: success the process of surgical intervention
timeFrame: Day 0
measure: Feasibility of ACC-DBS : neurological success of the process of chronic stimulation
timeFrame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
measure: Feasibility of ACC-DBS : psychiatric success of the process of chronic stimulation
timeFrame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
measure: Feasibility of ACC-DBS : cognitive success of the process of chronic stimulation
timeFrame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Secondary outcomes:
measure: Efficacy of ACC-DBS : change of pain intensity
timeFrame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
measure: Efficacy of ACC-DBS : change of pain intensity
timeFrame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
measure: Efficacy of ACC-DBS : change of pain intensity
timeFrame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
measure: Efficacy of ACC-DBS : change of quality of life by SF-36
timeFrame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
measure: Efficacy of ACC-DBS : change of quality of life by EQ-5D
timeFrame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Other outcomes:
Locations:
city: Nice
country: France
facility: Department of neurosurgery
Study officials:
affiliation: fontaine.d@chu-nice.fr
name: Denys FONTAINE
role: PRINCIPAL_INVESTIGATOR
References: