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

NCT ID: NCT06834269

Last Updated: 2025-02-28

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-02
• Study Completion Date: 2027-12-31

Brief Summary

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.

Conditions

Amyotrophic Lateral Sclerosis (ALS)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pwALS

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

Group Type: EXPERIMENTAL

Transcranial magnetic stimulation (tSMS)

Intervention Type: DEVICE

Transcranial static magnetic stimulation (tSMS) will be delivered simultaneously to both hemispheres, at the motor cortex (M1), via magnets housed in a helmet.

Interventions

Transcranial magnetic stimulation (tSMS)

Transcranial static magnetic stimulation (tSMS) will be delivered simultaneously to both hemispheres, at the motor cortex (M1), via magnets housed in a helmet.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Campus Bio-Medico University

OTHER

Sponsor Role: lead

Responsible Party

Di Lazzaro Vincenzo

Full Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fondazione Policlinico Campus Bio-Medico

Roma, RM, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Vincenzo Di Lazzaro

Role: CONTACT

v.dilazzaro@policlinicocampus.it

06 22541 1220

Facility Contacts

Vincenzo Di Lazzaro

Role: primary

v.dilazzaro@policlinicocampus.it

06 22541 1220

Other Identifiers

StaticALS

Identifier Type: -

Identifier Source: org_study_id