Anti MAG Neuropathy
Conditions
Keywords
anti-MAG antibody, peripheral neuropathy, photobiomodulation, monoclonal gammopathy
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.
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
RADIATIONphotobiomodulation
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.
Sponsors
Centre Hospitalier de Cornouaille
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To evaluate the efficacy of photobiomodulation in the symptomatic treatment of anti-MAG-induced peripheral neuropathies | From enrollment to the end of treatment at 3 months | Rasch-built Overall Disability Scale (R-ODS) score (0 to 48 = worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improving the quality of life for patients with anti-MAG peripheral neuropathy | From enrollment to the end of treatment at 3 months | EORTC QLQ-C30 score (28-112= worse outcome) |
| Stopping the progression of peripheral neuropathy | 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. |
| motor response of peripheral neuropathy | From enrollment to the end of treatment at 3 months | 10-meter walk test |
| toxicity of PBM | 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. |
| Efficacy of PBM in patient subgroups | 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) |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORLe Clech LLC Lenaig, doctor
Centre Hospitalier de Cornouaille
Outcome results
None listed