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

NCT07661667 | Enrolling By Invitation

• 1 other identifier: LASER-MAG
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anti MAG Neuropathy

Keywords

anti-MAG antibody; peripheral neuropathy; photobiomodulation; monoclonal gammopathy

Outcome Measures

Primary Outcomes (2)

• To evaluate the efficacy of photobiomodulation in the symptomatic treatment of anti-MAG-induced peripheral neuropathies

  Rasch-built Overall Disability Scale (R-ODS) score (0 to 48 = worse outcome)

  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

  Overall Neuropathy Limitations Scale (ONLS) score (0-12=worse outcome)

  From enrollment to the end of treatment at 3 months

Secondary Outcomes (6)

• Improving the quality of life for patients with anti-MAG peripheral neuropathy

  From enrollment to the end of treatment at 3 months

• Improving the quality of life for patients with anti-MAG peripheral neuropathy

  From enrollment to the end of treatment at 3 months

• Stopping the progression of peripheral neuropathy

  From enrollment to the end of treatment at 3 months

• motor response of peripheral neuropathy

  From enrollment to the end of treatment at 3 months

• toxicity of PBM

  From enrollment to the end of treatment at 3 months

Study Arms (1)

patients

patients with anti-MAG neuropathy due to IgM monoclonal gammopathy

Radiation: photobiomodulation

Interventions

photobiomodulation RADIATION

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.

Also known as: PBM, low laser therapy

patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients treated at the Cornouaille Hospital in the hematology and neurology departments

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier de Cornouaille: lead

Study Sites (1)

Centre hospitalier de Cornouaille

Quimper, 29107, France

Location

Related Publications (5)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Paraproteinemias

Interventions

Low-Level Light Therapy; phytobacteriomycin

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Laser Therapy; Therapeutics; Phototherapy

Study Officials

• Le Clech LLC Lenaig, doctor

  Centre Hospitalier de Cornouaille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 22, 2026
• Study Start: June 9, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 22, 2026

Record last verified: 2026-06

Locations

FR (1)