This Study Aims to Investigate the Efficacy of Photobiomodulation in the Treatment of Anti-MAG-induced Peripheral Neuropathy (LASER-MAG)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: photobiomodulation.
- Who it may be relevant to
- Registry conditions: Anti MAG Neuropathy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Efficacy of Photobiomodulation in the Treatment of Anti-MAG-Induced Peripheral Neuropathy: LASER-MAG Study.
Overview
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.
Detailed description
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).
Interventions
- Radiation 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.
Primary outcome measures
- To evaluate the efficacy of photobiomodulation in the symptomatic treatment of anti-MAG-induced peripheral neuropathies [Time frame: 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 [Time frame: From enrollment to the end of treatment at 3 months]
Secondary outcome measures (6)
- Improving the quality of life for patients with anti-MAG peripheral neuropathy [Time frame: From enrollment to the end of treatment at 3 months]
- Improving the quality of life for patients with anti-MAG peripheral neuropathy [Time frame: From enrollment to the end of treatment at 3 months]
- Stopping the progression of peripheral neuropathy [Time frame: From enrollment to the end of treatment at 3 months]
- motor response of peripheral neuropathy [Time frame: From enrollment to the end of treatment at 3 months]
- toxicity of PBM [Time frame: From enrollment to the end of treatment at 3 months]
- Efficacy of PBM in patient subgroups [Time frame: From enrollment to the end of treatment at 3 months]
Eligibility criteria
Inclusion criteria
- IgM gammopathy with the presence of anti-MAG antibodies
- symptomatic peripheral neuropathy
- patient agreement
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Centre hospitalier de Cornouaille — Quimper
Publications
- 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
Identifiers
NCT: NCT07661667 · LASER-MAG