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

NCT06834269 | Recruiting

• 1 other identifier: StaticALS
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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)

Keywords

Amyothrophic Lateral Sclerosis; ALS; tSMS; transcranial magnetic stimulation; NF-L; YKL-40; p75ECD; Biomarkers; transcranial static magnetic stimulation; TDP43

Outcome Measures

Primary Outcomes (1)

• NfL reduction

  The potential reduction of NfL during treatment is monitored by blood samples collected at baseline, and then , every 3 months during the treatment

  12 months

Secondary Outcomes (4)

• Monthly Progression Rate (MPR)

  15 months

• New Potential Theranostic Biomarkers Assay

  12 months

• Effect on resting motor threshold (RMT) and active motor threshold (AMT)

  12 months

• Effect on motor evoked potentials (MEP) size

  12 months

Study Arms (1)

pwALS

EXPERIMENTAL

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

Device: Transcranial magnetic stimulation (tSMS)

Interventions

Transcranial magnetic stimulation (tSMS) DEVICE

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

pwALS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Fondazione Policlinico Campus Bio-Medico

Roma, RM, 00128, Italy

RECRUITING

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Vincenzo Di Lazzaro

CONTACT

06 22541 1220; v.dilazzaro@policlinicocampus.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Neurology

Study Record Dates

• First Submitted: February 14, 2025
• First Posted: February 19, 2025
• Study Start: December 2, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: February 28, 2025

Record last verified: 2024-12

Locations

IT (1)