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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients | patients with anti-MAG neuropathy due to IgM monoclonal gammopathy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Improving the quality of life for patients with anti-MAG peripheral neuropathy | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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patients treated at the Cornouaille Hospital in the hematology and neurology departments
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| Name | Affiliation | Role |
|---|---|---|
| Le Clech LLC Lenaig, doctor | Centre Hospitalier de Cornouaille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre hospitalier de Cornouaille | Quimper | 29107 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37583505 | Background | 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. | |
| 41348001 | 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. |
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anonymized patient details sharing scientific results after the study is completed
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|
|
EORTC QLQ-CIPN20 score (20 - 80 = worse outcome) |
| From enrollment to the end of treatment at 3 months |
| Stopping the progression of peripheral neuropathy | 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 | 10-meter walk test | From enrollment to the end of treatment at 3 months |
| toxicity of PBM | 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 | 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 |
| 34834253 | 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. |
| 27887804 | 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. |
| 35312857 | 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. |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D010265 | Paraproteinemias |
| ID | Term |
|---|---|
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| C009924 | phytobacteriomycin |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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