Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DBS-ACC ON | Experimental | 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 |
|
| DBS-ACC OFF | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deep brain Stimulation of cingulum anterior | Procedure | The Deep brain Stimulation of cingulum anterior is alternatively ON and OFF while Thalamic stimulation is ON |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurence of serious adverse events. | 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 | 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 | 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 | 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 | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of ACC-DBS : change of pain intensity | 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 |
Not provided
Inclusion Criteria:
Non inclusion criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Denys FONTAINE | fontaine.d@chu-nice.fr | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of neurosurgery | Nice | 06000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39962366 | Background | 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. | |
| 38668642 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 | 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 | 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 | Efficacy of ACC-DBS will be evaluated by quality of life (EQ5D). | Day 0, Month 1, Month 4, Month 7, Month 10, Month 22 |
| 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. |