Anti MAG NeuropathyLASER-MAGNCT07661667
This Study Aims to Investigate the Efficacy of Photobiomodulation in the Treatment of Anti-MAG-induced Peripheral Neuropathy (LASER-MAG)
An observational study of Anti MAG Neuropathy, run by Centre Hospitalier de Cornouaille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anti MAG Neuropathy
- What is being tested?
- photobiomodulation
- Type of treatment
- Surgery or procedure
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2026to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients treated at the Cornouaille Hospital in the hematology and neurology departments
Who may be able to join
- IgM gammopathy with the presence of anti-MAG antibodies
- symptomatic peripheral neuropathy
- patient agreement
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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.
Read the 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).
- Conditions
- Anti MAG Neuropathy
- Being tested
- photobiomodulation
- Keywords
- anti-MAG antibody, peripheral neuropathy, photobiomodulation, monoclonal gammopathy
- Medical subject headings
- Peripheral Nervous System Diseases, Paraproteinemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
photobiomodulationRadiation
Also called PBM, low laser therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| patients | patients with anti-MAG neuropathy due to IgM monoclonal gammopathy Receives: Radiation: photobiomodulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: From enrollment to the end of treatment at 3 months
Secondary outcomes (6)
Improving the quality of life for patients with anti-MAG peripheral neuropathy
EORTC QLQ-C30 score (28-112= worse outcome)
Measured: From enrollment to the end of treatment at 3 months
Improving the quality of life for patients with anti-MAG peripheral neuropathy
EORTC QLQ-CIPN20 score (20 - 80 = worse outcome)
Measured: 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.
Measured: From enrollment to the end of treatment at 3 months
motor response of peripheral neuropathy
10-meter walk test
Measured: 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.
Measured: 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)
Measured: From enrollment to the end of treatment at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start9 Jun 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anti MAG NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Cornouaille
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Madame Rameau, Centre Hospitalier de Cornouaille
- Investigators
- Le Clech LLC Lenaig, doctor, Principal investigator, Centre Hospitalier de Cornouaille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661667
- Sponsor's protocol ID
- LASER-MAG
- Acronym
- LASER-MAG
- Status last verified
- Jun 2026
- First submitted
- 10 Jun 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: anonymized patient details sharing scientific results after the study is completed
Publications
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.
PubMed 37583505Jaccard 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.
PubMed 41348001Hanna 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.
PubMed 34834253Argenta 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.
PubMed 27887804Joy 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.
PubMed 35312857
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Photobiomodulation in the Treatment of Anti-MAG-Induced Peripheral Neuropathy: LASER-MAG Study.
- ClinicalTrials.gov ID
- NCT07661667
- Acronym / sponsor ID
- LASER-MAG / LASER-MAG
- Conditions
- Anti MAG Neuropathy
- Keywords
- anti-MAG antibody, peripheral neuropathy, photobiomodulation, monoclonal gammopathy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Centre Hospitalier de CornouailleUniversity, hospital or other
- Study start
- 9 Jun 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients | – | Radiation: photobiomodulationpatients with anti-MAG neuropathy due to IgM monoclonal gammopathy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated at the Cornouaille Hospital in the hematology and neurology departments
Key inclusion criteria (3 listed)
- IgM gammopathy with the presence of anti-MAG antibodies
- symptomatic peripheral neuropathy
- patient agreement
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| photobiomodulationAlso: PBM, low laser therapyEach 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. | Radiation | patients |
Primary outcome
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)
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)
6 secondary outcomes
Improving the quality of life for patients with anti-MAG peripheral neuropathy
Time frame: 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
Stopping the progression of peripheral neuropathy
Time frame: 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
toxicity of PBM
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
- Background: PubMed 37583505Ebadi 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.
- Background: PubMed 41348001Jaccard 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.
- Background: PubMed 34834253Hanna 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.
- Background: PubMed 27887804Argenta 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.
- Background: PubMed 35312857Joy 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.
- Individual participant dataSharing planned: Undecided. anonymized patient details sharing scientific results after the study is completed
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Le Clech LLC Lenaig, doctor principal investigator
Centre Hospitalier de Cornouaille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anti MAG Neuropathy, run by Centre Hospitalier de Cornouaille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07661667, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2026.