Safety and feasibility of deep brain stimulation of the anterior cingulate and thalamus in chronic refractory neuropathic pain: a pilot and randomized study
Abstract Background Deep Brain Stimulation (DBS) of the anterior cingulum has been recently proposed to treat refractory chronic pain but its safety and its efficacy have not been evaluated in controlled conditions. Our objective was to evaluate the respective feasibility and safety of sensory thala...
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BMC
2025-02-01
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| Series: | The Journal of Headache and Pain |
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| Online Access: | https://doi.org/10.1186/s10194-025-01967-8 |
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| author | Denys Fontaine Aurélie Leplus Anne Donnet Nelly Darmon Anne Balossier Bruno Giordana Benoit Simonet Petru Isan Jean Regis Michel Lanteri-Minet |
| author_facet | Denys Fontaine Aurélie Leplus Anne Donnet Nelly Darmon Anne Balossier Bruno Giordana Benoit Simonet Petru Isan Jean Regis Michel Lanteri-Minet |
| author_sort | Denys Fontaine |
| collection | DOAJ |
| description | Abstract Background Deep Brain Stimulation (DBS) of the anterior cingulum has been recently proposed to treat refractory chronic pain but its safety and its efficacy have not been evaluated in controlled conditions. Our objective was to evaluate the respective feasibility and safety of sensory thalamus (Thal-DBS) combined with anterior cingulate (ACC-DBS) DBS in patients suffering from chronic neuropathic pain. Methods We conducted a bicentric study (clinicaltrials.gov NCT03399942) in patients suffering from medically-refractory chronic unilateral neuropathic pain surgically implanted with both unilateral Thal-DBS and bilateral ACC-DBS, to evaluate successively: Thal-DBS only; combined Thal-DBS and ACC-DBS; ACC-DBS “on” and “off” stimulation periods in randomized cross-over double-blinded conditions; and a 1-year open phase. Safety and efficacy were evaluated by repeated neurological examination, psychiatric assessment, comprehensive assessment of cognitive and affective functioning. Changes on pain intensity (Visual Analogic Scale) and quality of life (EQ-5D scale) were used to evaluate DBS efficacy. Results All the patients (2 women, 6 men, mean age 52,1) completed the study. Adverse events were: epileptic seizure (2), transient motor or attention (2), persistent gait disturbances (1), sleep disturbances (1). No patient displayed significant cognitive or affective change. Compared to baseline, the quality of life (EQ-5D utility score) was significantly improved during the ACC-DBS “On” stimulation period (p = 0,039) and at the end of the study (p = 0,034). Conclusion This pilot study confirmed the safety of anterior cingulate DBS alone or in combination with thalamic stimulation and suggested that it might improve quality of life of patients with chronic refractory neuropathic pain. Trial registration The study has been registered on 20,180,117 (clinicaltrials.gov NCT03399942). |
| format | Article |
| id | doaj-art-bb66eaefb20042889496b84fcd070829 |
| institution | OA Journals |
| issn | 1129-2377 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMC |
| record_format | Article |
| series | The Journal of Headache and Pain |
| spelling | doaj-art-bb66eaefb20042889496b84fcd0708292025-08-20T02:15:06ZengBMCThe Journal of Headache and Pain1129-23772025-02-0126111110.1186/s10194-025-01967-8Safety and feasibility of deep brain stimulation of the anterior cingulate and thalamus in chronic refractory neuropathic pain: a pilot and randomized studyDenys Fontaine0Aurélie Leplus1Anne Donnet2Nelly Darmon3Anne Balossier4Bruno Giordana5Benoit Simonet6Petru Isan7Jean Regis8Michel Lanteri-Minet9Department of Neurosurgery, Université Côte d’Azur, CHU de NiceDepartment of Neurosurgery, Université Côte d’Azur, CHU de NiceFHU INOVPAIN, CHU de NiceUniversité Côte d’Azur, UR2CAINSERM (INS) UMR1106, Department of Functional Neurosurgery & Radiosurgery, Aix Marseille UniversityUniversité Côte d’Azur, UR2CADepartment of Neurosurgery, Université Côte d’Azur, CHU de NiceDepartment of Neurosurgery, Université Côte d’Azur, CHU de NiceINSERM (INS) UMR1106, Department of Functional Neurosurgery & Radiosurgery, Aix Marseille UniversityUniversité Côte d’Azur, UR2CAAbstract Background Deep Brain Stimulation (DBS) of the anterior cingulum has been recently proposed to treat refractory chronic pain but its safety and its efficacy have not been evaluated in controlled conditions. Our objective was to evaluate the respective feasibility and safety of sensory thalamus (Thal-DBS) combined with anterior cingulate (ACC-DBS) DBS in patients suffering from chronic neuropathic pain. Methods We conducted a bicentric study (clinicaltrials.gov NCT03399942) in patients suffering from medically-refractory chronic unilateral neuropathic pain surgically implanted with both unilateral Thal-DBS and bilateral ACC-DBS, to evaluate successively: Thal-DBS only; combined Thal-DBS and ACC-DBS; ACC-DBS “on” and “off” stimulation periods in randomized cross-over double-blinded conditions; and a 1-year open phase. Safety and efficacy were evaluated by repeated neurological examination, psychiatric assessment, comprehensive assessment of cognitive and affective functioning. Changes on pain intensity (Visual Analogic Scale) and quality of life (EQ-5D scale) were used to evaluate DBS efficacy. Results All the patients (2 women, 6 men, mean age 52,1) completed the study. Adverse events were: epileptic seizure (2), transient motor or attention (2), persistent gait disturbances (1), sleep disturbances (1). No patient displayed significant cognitive or affective change. Compared to baseline, the quality of life (EQ-5D utility score) was significantly improved during the ACC-DBS “On” stimulation period (p = 0,039) and at the end of the study (p = 0,034). Conclusion This pilot study confirmed the safety of anterior cingulate DBS alone or in combination with thalamic stimulation and suggested that it might improve quality of life of patients with chronic refractory neuropathic pain. Trial registration The study has been registered on 20,180,117 (clinicaltrials.gov NCT03399942).https://doi.org/10.1186/s10194-025-01967-8Chronic PainNeuropathic painDeep brain stimulationCingulate cortexThalamus |
| spellingShingle | Denys Fontaine Aurélie Leplus Anne Donnet Nelly Darmon Anne Balossier Bruno Giordana Benoit Simonet Petru Isan Jean Regis Michel Lanteri-Minet Safety and feasibility of deep brain stimulation of the anterior cingulate and thalamus in chronic refractory neuropathic pain: a pilot and randomized study The Journal of Headache and Pain Chronic Pain Neuropathic pain Deep brain stimulation Cingulate cortex Thalamus |
| title | Safety and feasibility of deep brain stimulation of the anterior cingulate and thalamus in chronic refractory neuropathic pain: a pilot and randomized study |
| title_full | Safety and feasibility of deep brain stimulation of the anterior cingulate and thalamus in chronic refractory neuropathic pain: a pilot and randomized study |
| title_fullStr | Safety and feasibility of deep brain stimulation of the anterior cingulate and thalamus in chronic refractory neuropathic pain: a pilot and randomized study |
| title_full_unstemmed | Safety and feasibility of deep brain stimulation of the anterior cingulate and thalamus in chronic refractory neuropathic pain: a pilot and randomized study |
| title_short | Safety and feasibility of deep brain stimulation of the anterior cingulate and thalamus in chronic refractory neuropathic pain: a pilot and randomized study |
| title_sort | safety and feasibility of deep brain stimulation of the anterior cingulate and thalamus in chronic refractory neuropathic pain a pilot and randomized study |
| topic | Chronic Pain Neuropathic pain Deep brain stimulation Cingulate cortex Thalamus |
| url | https://doi.org/10.1186/s10194-025-01967-8 |
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