Trial reportThe journal of headache and pain2025
Safety and feasibility of deep brain stimulation of the anterior cingulate and thalamus in chronic refractory neuropathic pain: a pilot and randomized study.
Trial report in The journal of headache and pain, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03399942 (Treatment of Chronic Refractory Pain by Combined Deep Brain Stimulation of the Anterior Cingulum and Sensory Thalamus), which is not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Treatment of Chronic Refractory Pain by Combined Deep Brain Stimulation of the Anterior Cingulum and Sensory Thalamus: a Feasibility and Safety Study
Who cites it
9 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Functional brain alterations associated with acupuncture for chronic pain: a scoping review of fMRI studies.Frontiers in neuroscience · 2026Pooled it
- Human intracranial signal stability tracks anatomical accuracy after electrode reimplantation.Journal of neural engineering · 2026Trial
- Multi-focal ultrasound neuromodulation to the dorsal anterior cingulate cortex disrupts behavioural and neural pain processing.Nature communications · 2026Trial
- Deep brain stimulation mechanisms in comorbid pain and emotional dysregulation from animal models.iScience · 2026Review
- Comorbidity Mechanism and Management of Chronic Low Back Pain and Major Depressive Disorder: From Neural Circuit Remodeling to Precision Medicine.Brain and behavior · 2026Review
- Neuroimaging-Guided Insights into the Molecular and Network Mechanisms of Chronic Pain and Neuromodulation.International journal of molecular sciences · 2026Review
- Efficacy of intracranial surgical treatments for chronic pain: A systematic review and meta-analysis.Brain & spine · 2026Review
- Maladaptive reorganization of mediodorsal thalamus as a central mechanism in neuropathic pain-related sleep disorders.Military Medical Research · 2026Article
- A bioelectromagnetic hypothesis of chronic primary pain: from thalamocortical dysrhythmia to the consciousness-brain interface.Frontiers in pain research (Lausanne, Switzerland) · 2026Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
backgroundDeep 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.
methodsWe 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.
resultsAll 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).
conclusionThis 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 registrationThe study has been registered on 20,180,117 (clinicaltrials.gov NCT03399942).
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.