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Completed

NCT Number: NCT03399942

Combined Cingulate and Thalamic DBS for Chronic Refractory Chronic Pain

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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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of neurosurgery

Nice, 06000, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Deep brain Stimulation of cingulum anterior

Procedure

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

Primary outcomes

  1. Occurence of serious adverse events.

    Time frame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22

    description of serious adverse events

  2. 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

  3. 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

  4. 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

  5. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 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).

  5. 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).

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: EMOPAIN

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Jan 17, 2018
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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