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

June 16, 2026 updated by: Madame Rameau, Centre Hospitalier de Cornouaille

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

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.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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).

Study Type

Observational

Enrollment (Estimated)

10

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Quimper, France, 29107
        • Centre Hospitalier de Cornouaille

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
patients
patients with anti-MAG neuropathy due to IgM monoclonal gammopathy
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.
Other Names:
  • low laser therapy
  • PBM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
Time Frame: From enrollment to the end of treatment at 3 months
Overall Neuropathy Limitations Scale (ONLS) score (0-12=worse outcome)
From enrollment to the end of treatment at 3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improving the quality of life for patients with anti-MAG peripheral neuropathy
Time Frame: From enrollment to the end of treatment at 3 months
EORTC QLQ-C30 score (28-112= worse outcome)
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
EORTC QLQ-CIPN20 score (20 - 80 = worse outcome)
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
Neuropathic Pain Symptom Inventory (NPSI) score. Each question is rated on a scale from 0 to 10, where 0 means no pain at all and 10 means the worst pain.
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
10-meter walk test
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
Neuropathic Pain Symptom Inventory (NPSI) score. Each question is rated on a scale from 0 to 10, where 0 means no pain at all and 10 means the worst pain.
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
comparison of scores based on prior treatments received (anti-CD20 monoclonal antibody, polyvalent immunoglobulins, plasma exchange, corticosteroids)
From enrollment to the end of treatment at 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier de Cornouaille

Investigators

  • Principal Investigator: Le Clech LLC Lenaig, doctor, Centre Hospitalier de Cornouaille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 10, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

June 22, 2026

Last Update Submitted That Met QC Criteria

June 16, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LASER-MAG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

anonymized patient details sharing scientific results after the study is completed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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