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Enrolling by Invitation

NCT Number: NCT07661667

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

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.

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Key information

Conditions

Anti MAG Neuropathy Blood Protein Disorders Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Nervous System Diseases Neuromuscular Diseases Paraproteinemias Peripheral Nervous System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre hospitalier de Cornouaille

Quimper, 29107, France

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: PBM, low laser therapy

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. 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.

  4. motor response of peripheral neuropathy

    Time frame: From enrollment to the end of treatment at 3 months

    10-meter walk test

  5. 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.

  6. 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)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier de Cornouaille

Other

Registry information

Official study title

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

Acronym: LASER-MAG

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2026
Registry last updated
Jun 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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