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

N/AEnrolling By InvitationNCT07661667

Centre Hospitalier de Cornouaille10 enrolled

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.

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

Conditions

Anti MAG Neuropathy

Interventions

photobiomodulationRADIATION

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Centre hospitalier de Cornouaille

Quimper, France

Outcomes

Primary Outcomes

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)