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Набор по приглашению NCT07661667

This Study Aims to Investigate the Efficacy of Photobiomodulation in the Treatment of Anti-MAG-induced Peripheral Neuropathy (LASER-MAG)

— Наблюдательное Anti MAG Neuropathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: photobiomodulation.
Кому может быть актуально
Состояния в реестре: Anti MAG Neuropathy. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

The Efficacy of Photobiomodulation in the Treatment of Anti-MAG-Induced Peripheral Neuropathy: LASER-MAG Study.

Обзор

Patients treated in the hematology department of the Quimper/Cornouaille Hospital Center for IgM monoclonal gammopathy with anti-MAG and symptomatic peripheral neuropathy often reach a therapeutic impasse. The treatment of neuropathic pain is complex, but recently a new non-pharmacological therapy, photobiomodulation, has shown evidence of efficacy and improved quality of life in the treatment of these peripheral neuropathies. This new therapy uses low-intensity lasers; it is non-invasive, athermic, and has no reported side effects. The general principle is to expose tissues to visible light in the red and near-infrared spectrum to elicit a biological response. The study aims to evaluate the efficacy and tolerability of photobiomodulation in this population of patients with anti-MAG neuropathy.

Подробное описание

The protocol includes 16 photobiomodulation sessions, with monitoring of disability scores (ONLS, R-ODS), pain scores (NPSI), and quality of life scores (QLQ C30, QLQ CIPN20).

Вмешательства

  • Лучевая терапия photobiomodulation
    Each patient receives 16 sessions of PBM over 6 weeks using the ATP38 device. Both upper limbs are treated simultaneously for 12 minutes each. The lower limbs are also treated for 12 minutes each. Assessments of disability (ONLS, R-ODS), pain (NPSI), and quality of life (QLQ C30, QLQ CIPN20) are conducted weekly. Neurological and hematological consultations are conducted before and after PBM sessions.

Первичные конечные точки

  • To evaluate the efficacy of photobiomodulation in the symptomatic treatment of anti-MAG-induced peripheral neuropathies [Срок оценки: From enrollment to the end of treatment at 3 months]
  • To evaluate the efficacy of photobiomodulation in the symptomatic treatment of anti-MAG-induced peripheral neuropathies [Срок оценки: From enrollment to the end of treatment at 3 months]
Вторичные конечные точки (6)
  • Improving the quality of life for patients with anti-MAG peripheral neuropathy [Срок оценки: From enrollment to the end of treatment at 3 months]
  • Improving the quality of life for patients with anti-MAG peripheral neuropathy [Срок оценки: From enrollment to the end of treatment at 3 months]
  • Stopping the progression of peripheral neuropathy [Срок оценки: From enrollment to the end of treatment at 3 months]
  • motor response of peripheral neuropathy [Срок оценки: From enrollment to the end of treatment at 3 months]
  • toxicity of PBM [Срок оценки: From enrollment to the end of treatment at 3 months]
  • Efficacy of PBM in patient subgroups [Срок оценки: From enrollment to the end of treatment at 3 months]

Критерии участия

Критерии включения

  • IgM gammopathy with the presence of anti-MAG antibodies
  • symptomatic peripheral neuropathy
  • patient agreement

Критерии исключения

  • Patients with a solid tumor located in areas exposed to PBM
  • Patients under legal guardianship (guardianship, conservatorship...)
  • cognitive disorders
  • Peripheral neuropathy of other aetiologies
  • Declining to participate

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Франция · 1 центр
  • Centre hospitalier de Cornouaille — Quimper

Публикации

  • Ebadi SA, Tabeie F, Tavakoli S, Khalili S. Effects of Photobiomodulation With Two Wavelengths of 630 and 810 nm on Diabetic Neuropathy. J Lasers Med Sci. 2023 Jul 25;14:e22. doi: 10.34172/jlms.2023.22. eCollection 2023. PMID 37583505
  • Jaccard A, Magy L, Arnulf B, Bridoux F, Roussel M. Monoclonal-related neuropathies: diagnosis, prognosis, and outcomes. Hematology Am Soc Hematol Educ Program. 2025 Dec 5;2025(1):385-392. doi: 10.1182/hematology.2025000728. PMID 41348001
  • Hanna R, Dalvi S, Bensadoun RJ, Raber-Durlacher JE, Benedicenti S. Role of Photobiomodulation Therapy in Neurological Primary Burning Mouth Syndrome. A Systematic Review and Meta-Analysis of Human Randomised Controlled Clinical Trials. Pharmaceutics. 2021 Nov 2;13(11):1838. doi: 10.3390/pharmaceutics13111838. PMID 34834253
  • Argenta PA, Ballman KV, Geller MA, Carson LF, Ghebre R, Mullany SA, Teoh DG, Winterhoff BJ, Rivard CL, Erickson BK. The effect of photobiomodulation on chemotherapy-induced peripheral neuropathy: A randomized, sham-controlled clinical trial. Gynecol Oncol. 2017 Jan;144(1):159-166. doi: 10.1016/j.ygyno.2016.11.013. Epub 2016 Nov 22. PMID 27887804
  • Joy L, Jolien R, Marithe C, Stijn E, Laura S, Hilde L, Sandra B, Wendy N, Ruth H, Liesbeth R, Sylvana S, Sylvia H, Jeroen M. The use of photobiomodulation therapy for the prevention of chemotherapy-induced peripheral neuropathy: a randomized, placebo-controlled pilot trial (NEUROLASER trial). Support Care Cancer. 2022 Jun;30(6):5509-5517. doi: 10.1007/s00520-022-06975-x. Epub 2022 Mar 21. PMID 35312857

Идентификаторы

NCT: NCT07661667 · LASER-MAG

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗