Transcranial Static Magnetic Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis.

Campus Bio-Medico University of Rome

Status: Enrolling

Conditions: Amyotrophic Lateral Sclerosis (ALS)

Treatments: Device: Transcranial magnetic stimulation (tSMS)

Study type: Interventional

Funder types: Other

Identifiers

NCT06834269

StaticALS

Details and patient eligibility

About

The objective of the present study is to assess the efficacy of tSMS in ALS patients. This will be achieved by monitoring:

• levels of NF-L and other potential innovative biomarkers,
• clinical progression, trough ALSFRS-R. After at least three-month follow-up, participants will be recruited to undergo biemispheric tSMS for two daily sessions of 120 minutes each, at home, for 12 months. Together with clinical status, which will be evalueted each three months, blood and urine samples will be collected before the start of the tSMS administration (M0) and during the treatment (M3, M6, M9, M12), to detect potential theranostic biomarkers. In a subgroup of patients, ad additional blood and urine sample will be collected 3 months before M0 (M-3).

Moreover, cortical excitability will be tested through transcranial magnetic stimulation (TMS) before and after the tSMS stimulation period.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥ 18
• diagnosis of possible, probable or definite ALS according to revised El Escorial criteria and Awaji-Shima criteria
• disease duration < 24 months
• ALSFRS-R > 30 at the recruitment
• ALSFRS-R decline > 1 in the at least 3-months period before the intervention
• normal respiratory functionality at the preliminary evaluation (M-3), assessed in the previous month (FVC ≥ 75% and ALSFRS-R items 10,11,12 > 4)
• treatment with riluzole 50 mg x 2/die

Exclusion criteria

• inclusion in other clinical trials
• presence of tracheotomy or/and PEG (percutaneous endoscopic gastrostomy)
• unable to perform spirometry due to severe bulbar involvement
• contraindications to magnetic fields exposure
• pregnancy or breastfeeding
• history of epilepsy or seizures
• use of drugs acting on central nervous system, except for antidepressive drugs and benzodiazepines.
• cognitive impairment
• lack of informed consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

pwALS

Experimental group

Description:

All participants will undergo tSMS administration at home, in two daily sessions of 120 minutes each.

Treatment:

Device: Transcranial magnetic stimulation (tSMS)