Department of neurosurgery
Nice, 06000, France
NCT Number: NCT03399942
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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Notify Me18 year–70 year
All sexes
Interventional
Not applicable
Nice, 06000, France
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Non inclusion criteria:
The Deep brain Stimulation of cingulum anterior is alternatively ON and OFF while Thalamic stimulation is ON
Time frame: Day 0, Month 1, Month 4, Month 7, Month 10, Month 22
description of serious adverse events
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
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
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
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
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)
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)
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)
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).
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).
Centre Hospitalier Universitaire de Nice
Other
Treatment of Chronic Refractory Pain by Combined Deep Brain Stimulation of the Anterior Cingulum and Sensory Thalamus: a Feasibility and Safety Study
Acronym: EMOPAIN
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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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