Combined Cingulate and Thalamic DBS for Chronic Refractory Chronic Pain (EMOPAIN)

Centre Hospitalier Universitaire de Nice

Status: Active, not recruiting

Conditions: Chronic Refractory Neuropathic Pain

Treatments: Procedure: Deep brain Stimulation of cingulum anterior

Study type: Interventional

Funder types: Other

Identifiers

NCT03399942

16-AOIP-01

Details and patient eligibility

About

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.

Full 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

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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,

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

10 participants in 2 patient groups

DBS-ACC ON

Experimental group

Description:

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

Treatment:

Procedure: Deep brain Stimulation of cingulum anterior

DBS-ACC OFF

Experimental group

Description:

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

Treatment:

Procedure: Deep brain Stimulation of cingulum anterior