Determining the effectiveness of transcranial and intranasal low power laser in improving the symptoms of patients with amyotrophic lateral sclerosis

Determining the effectiveness of transcranial and intranasal low power laser in patients with amyotrophic lateral sclerosis

Clinical trial with control group, with randomized parallel groups, double-blind phase 3 on 34 patients.

This study will be conducted in Firouzgar Hospital, Tehran. In the selection of participants to the study groups, we will use the block randomization method, and the blinding in this study is a double-blind type. Also, the participants will not be informed about the type of interventions. Participants will be allocated to receive the intervention and placebo. The duration of the study is 6 weeks (5 sessions per week) and biochemical analyses, quality of life, sleep quality, pain, pseudobulbar effects and improvement of motor symptoms are measured at the specified times.

Have ALS_FRS score > 24 Have MND nerve tape Not having a serious medical condition other than ALS Not having a major psychiatric and neurological disorder No drug addiction Exclusion criteria Patients need special care for respiratory failure Have a metabolic disorder Have a history of moderate or severe brain damage or stroke Have a history of cardiac arrhythmia Have kidney disease, such as chronic kidney failure Failure to participate in 3 sessions will be excluded from the study

Intervention group: The near infrared (NIR) PBM will be transcranial and intranasal with a wavelength of 810 nm and a pulse of 10 Hz, for a duration of 20 minutes. The duration of the intervention is 6 weeks, with five sessions per week. sham group: The device will be placed on the patient's head

Improvement of movement symptoms; improving the quality of sleep; improving the quality of life; reducing the amount of pain; Reducing inflammation and antioxidant effects

To prevent the occurrence of bias in selecting participants for study groups, we will use the randomization method until the researchers' opinion is reduced in selecting participants for the study groups. Participants after selecting to study with blocked randomization method (with random blocks) will be allocated to receive intervention and placebo. The Random Allocation Software will be use to a randomization process since this study consists of two groups, the output of the allocation of participants will be specified with the A and B until intervention to be blinded for the members of the research team. In the software, randomization type will be selected of block randomization, with random blocks. Software output of the allocation participants is not predictable on the basis of blocks.

We will inform the supervisor after selecting each patient for the study and they are based on the randomized output of the randomization software and its matching to the patient's number the intervention will be sent in a form that is not known to the patients, prescriptive, and evaluator of the outcomes. Blinding process in this study is double blinded. Participants in the study will be blinded of interventions also the physicians will be blinded of the type of interventions received by the participants when they evaluated the outcome.

Finding of the study, demographic data of participants in the study, in addition to descriptive and analytical analysis of variables.

Availability six months after the end of study

Researchers and people working in the industry

Requests may be made by organizations, journals or project supervisors. These requests will be read by the research team under the supervision of a university representative, and if the requests are reasonable, relevant de-identified data will be sent. This request may be some results of biomarkers or codes performed for data analysis.

The initial request can be sent to the email of the people who are in the scientific and general response section of the trial (soraya.mehrabi@gmail.com, homa.talebi448686@gmail.com). Applicants can also refer to the Research Vice-Chancellor of Iran University of Medical Sciences located on Hemet Highway or the Iran Clinical Trial Center located in the Central Library of Iran University of Medical Sciences.

After the institution agrees to send data for requests, depending on whether the requester is inside the country or abroad, and also according to the type of requested data, the time to respond to the requests will be different. Finally, no request will take more than one month.