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Chronic Refractory Neuropathic PainEMOPAINNCT03399942

Combined Cingulate and Thalamic DBS for Chronic Refractory Chronic Pain

A study testing Deep brain Stimulation of cingulum anterior in people with Chronic Refractory Neuropathic Pain, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Chronic Refractory Neuropathic Pain
What is being tested?
Deep brain Stimulation of cingulum anterior
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteFrance
Study dates
6 Apr 2018to 2 Oct 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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),
Show all 9Show fewer
  • DSMIV axis I psychiatric disorder,
  • contra-indication to surgery, anesthesia or MRI;
  • patient responder to rTMS,

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

France1 site

  • Department of neurosurgery

    Nice, 06000

Other trials in France

About this study

Official title: 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.

Read the 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

Being tested
Deep brain Stimulation of cingulum anterior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Deep brain Stimulation of cingulum anteriorProcedure or surgery

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

Study groups in NCT03399942
Study groupRoleWhat they receive
DBS-ACC ONExperimentalStart 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
Receives: Procedure: Deep brain Stimulation of cingulum anterior
DBS-ACC OFFExperimentalStart 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
Receives: Procedure: Deep brain Stimulation of cingulum anterior

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Occurence of serious adverse events.

    description of serious adverse events

    Measured: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22

  2. Feasibility of ACC-DBS: success the process of surgical intervention

    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

    Measured: Day 0

  3. Feasibility of ACC-DBS : neurological success of the process of chronic stimulation

    neurological success of the process of chronic stimulation will be evaluated by the neurological examination

    Measured: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22

  4. Feasibility of ACC-DBS : psychiatric success of the process of chronic stimulation

    psychiatric success of the process of chronic stimulation will be evaluated by the psychiatric assessment

    Measured: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22

  5. Feasibility of ACC-DBS : cognitive success of the process of chronic stimulation

    cognitive success of the process of chronic stimulation will be evaluated by the cognitive assessment

    Measured: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22

Secondary outcomes (5)

  1. Efficacy of ACC-DBS : change of pain intensity

    Efficacy of ACC-DBS will be evaluated by pain intensity (VAS)

    Measured: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22

  2. Efficacy of ACC-DBS : change of pain intensity

    Efficacy of ACC-DBS will be evaluated by pain intensity (Brief Pain Inventory)

    Measured: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22

  3. Efficacy of ACC-DBS : change of pain intensity

    Efficacy of ACC-DBS will be evaluated by pain intensity (McGill Pain Questionnaire)

    Measured: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22

  4. Efficacy of ACC-DBS : change of quality of life by SF-36

    Efficacy of ACC-DBS will be evaluated by quality of life (SF36).

    Measured: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22

  5. Efficacy of ACC-DBS : change of quality of life by EQ-5D

    Efficacy of ACC-DBS will be evaluated by quality of life (EQ5D).

    Measured: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jan 2018
  2. Study start6 Apr 2018
  3. Primary completion17 Apr 2023
  4. Study completion2 Oct 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03399942
Sponsor's protocol ID
16-AOIP-01
Acronym
EMOPAIN
Status last verified
Mar 2026
First submitted
1 Dec 2017
Last updated
24 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Fontaine D, Leplus A, Donnet A, Darmon N, Balossier A, Giordana B, Simonet B, Isan P, Regis J, Lanteri-Minet M. Safety and feasibility of deep brain stimulation of the anterior cingulate and thalamus in chronic refractory neuropathic pain: a pilot and randomized study. J Headache Pain. 2025 Feb 17;26(1):35. doi: 10.1186/s10194-025-01967-8.

    PubMed 39962366

  • Leplus A, Isan P, Balossier A, Mouffok S, Donnet A, Papadopoulo T, Lanteri-Minet M, Regis J, Fontaine D. Somatotopy of the sensory thalamus: inputs from directional deep brain stimulation in pain patients. Ann Clin Transl Neurol. 2024 Jun;11(6):1502-1513. doi: 10.1002/acn3.52067. Epub 2024 Apr 26.

    PubMed 38668642

Questions about this trial

What is this clinical trial studying?

A study testing Deep brain Stimulation of cingulum anterior in people with Chronic Refractory Neuropathic Pain, run by Centre Hospitalier Universitaire de Nice at 1 site in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Occurence of serious adverse events. (time frame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03399942, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.

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