Combined Cingulate and Thalamic DBS for Chronic Refractory Chronic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-06

Study Completion Date

2024-03-20

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Chronic Refractory Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DBS-ACC ON

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

Group Type EXPERIMENTAL

Deep brain Stimulation of cingulum anterior

Intervention Type PROCEDURE

The Deep brain Stimulation of cingulum anterior is alternatively ON and OFF while Thalamic stimulation is ON

DBS-ACC OFF

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

Group Type EXPERIMENTAL

Deep brain Stimulation of cingulum anterior

Intervention Type PROCEDURE

The Deep brain Stimulation of cingulum anterior is alternatively ON and OFF while Thalamic stimulation is ON

Interventions

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Deep brain Stimulation of cingulum anterior

The Deep brain Stimulation of cingulum anterior is alternatively ON and OFF while Thalamic stimulation is ON

Intervention Type PROCEDURE

Eligibility Criteria

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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.

* 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,

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No