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

March 20, 2026 updated by: Centre Hospitalier Universitaire de Nice

Treatment of Chronic Refractory Pain by Combined Deep Brain Stimulation of the Anterior Cingulum and Sensory Thalamus: a Feasibility and Safety Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nice, France, 06000
        • Department of Neurosurgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Procedure: Deep brain Stimulation of cingulum anterior
The Deep brain Stimulation of cingulum anterior is alternatively ON and OFF while Thalamic stimulation is ON
Experimental: 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
Procedure: Deep brain Stimulation of cingulum anterior
The Deep brain Stimulation of cingulum anterior is alternatively ON and OFF while Thalamic stimulation is ON

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurence of serious adverse events.
Time Frame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
description of serious adverse events
Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Feasibility of ACC-DBS: success the process of surgical intervention
Time Frame: 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
Day 0
Feasibility of ACC-DBS : neurological success of the process of chronic stimulation
Time Frame: 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
Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Feasibility of ACC-DBS : psychiatric success of the process of chronic stimulation
Time Frame: 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
Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Feasibility of ACC-DBS : cognitive success of the process of chronic stimulation
Time Frame: 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
Day 0, Month 1, Month 4, Month 7, Month 10, Month 22

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of ACC-DBS : change of pain intensity
Time Frame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Efficacy of ACC-DBS will be evaluated by pain intensity (VAS)
Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Efficacy of ACC-DBS : change of pain intensity
Time Frame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Efficacy of ACC-DBS will be evaluated by pain intensity (Brief Pain Inventory)
Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Efficacy of ACC-DBS : change of pain intensity
Time Frame: 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)
Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Efficacy of ACC-DBS : change of quality of life by SF-36
Time Frame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Efficacy of ACC-DBS will be evaluated by quality of life (SF36).
Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Efficacy of ACC-DBS : change of quality of life by EQ-5D
Time Frame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
Efficacy of ACC-DBS will be evaluated by quality of life (EQ5D).
Day 0, Month 1, Month 4, Month 7, Month 10, Month 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: Denys FONTAINE, fontaine.d@chu-nice.fr

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2018

Primary Completion (Actual)

April 17, 2023

Study Completion (Actual)

October 2, 2024

Study Registration Dates

First Submitted

December 1, 2017

First Submitted That Met QC Criteria

January 8, 2018

First Posted (Actual)

January 17, 2018

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 20, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-AOIP-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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