Neuromodulation : journal of the International Neuromodulation Society · 2025
Insula Deep Brain Stimulation for Neuropathic Pain: A Cross-Over, Randomized, Sham-Controlled Trial.
СтатьяРандомизированное исследованиеКлиническое исследование II фазыНазвание и аннотация: Перевод пока не подготовлен
Обработка статьи · этапы, ошибки и управление
Загрузка состояния…
Ошибки и ограничения
История · было → стало
Состояние обновляется каждые 5 секунд, пока блок открыт. Процент показывается только там, где известен объём работы. Пауза останавливает продолжение этапа; текущий запрос к источнику может завершиться.
Dongyang Liu, Cunha Pedro Henrique M, Lapa Jorge D S, Kubota Gabriel T, Junior Jefferson Rosi, Fernandes Ana Mércia, Thibes Raissa B, Pinheiro Denise S, Iglesio Ricardo F, Duarte Kleber P, Sato João, da Silva Valquiria A, Lucato Leandro T, Figueiredo Eberval G, Carlotti Junior Carlos Gilberto, Yeng Lin T, Teixeira Manoel J, de Andrade Daniel C
Аннотация
OBJECTIVE: Despite neuropathic pain affecting a significant portion of the population, many people still experience refractory conditions. Here, we evaluated the efficacy and safety of posterior-superior insula deep brain stimulation for pharmaco-resistant neuropathic pain.
MATERIALS AND METHODS: This was a phase 2 randomized, double-blind, sham-controlled, cross-over trial. Subjects with chronic pharmaco-resistant neuropathic pain, whose pain had previously responded to deep repetitive transcranial magnetic stimulation of the posterior-superior insula, underwent stereotactically guided implantation of electrodes targeting this same region. The study comprised three phases: double-blind (2 × three months), single-blind (three months), and open-label (six months). The primary outcome was the proportion of participants achieving ≥30% reduction in average pain intensity compared with baseline. Secondary outcomes included pain interference, quality of life, and neuropsychiatric assessments.
RESULTS: Ten participants (80% men; age range: 31-67 years) were enrolled. There was an 82.3% posterior probability that active posterior-superior insula-deep brain stimulation yields a higher responder rate than does sham stimulation after three months, with a 95% credible interval for the difference ranging from 10% to 130%. Probabilities of pain interference score reduction exceeded 95% during follow-up, particularly concerning sleep and mood. Quality-of-life scores also showed significant improvements under active, compared with sham, stimulation treatments. No major adverse events were reported, and the stimulation was well tolerated.
INTERPRETATION: This study showed that posterior-superior insula deep brain stimulation is a feasible and potentially useful treatment for people with refractory neuropathic pain, with reasonable safety profiles. Phase 3 trials are warranted to confirm these findings and to explore the applicability of this intervention.
CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT04279548.
MATERIALS AND METHODS: This was a phase 2 randomized, double-blind, sham-controlled, cross-over trial. Subjects with chronic pharmaco-resistant neuropathic pain, whose pain had previously responded to deep repetitive transcranial magnetic stimulation of the posterior-superior insula, underwent stereotactically guided implantation of electrodes targeting this same region. The study comprised three phases: double-blind (2 × three months), single-blind (three months), and open-label (six months). The primary outcome was the proportion of participants achieving ≥30% reduction in average pain intensity compared with baseline. Secondary outcomes included pain interference, quality of life, and neuropsychiatric assessments.
RESULTS: Ten participants (80% men; age range: 31-67 years) were enrolled. There was an 82.3% posterior probability that active posterior-superior insula-deep brain stimulation yields a higher responder rate than does sham stimulation after three months, with a 95% credible interval for the difference ranging from 10% to 130%. Probabilities of pain interference score reduction exceeded 95% during follow-up, particularly concerning sleep and mood. Quality-of-life scores also showed significant improvements under active, compared with sham, stimulation treatments. No major adverse events were reported, and the stimulation was well tolerated.
INTERPRETATION: This study showed that posterior-superior insula deep brain stimulation is a feasible and potentially useful treatment for people with refractory neuropathic pain, with reasonable safety profiles. Phase 3 trials are warranted to confirm these findings and to explore the applicability of this intervention.
CLINICAL TRIAL REGISTRATION: The Clinicaltrials.gov registration number for the study is NCT04279548.