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

Overview

Official title

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

Brief title

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

Registration type

ClinicalTrials.gov

NCT number

NCT06834269

Status

Active, not recruiting

Study category

Interventional, Device, Biomarker

Sponsor / center

Campus Bio-Medico University

Research center

Not stated in the official study record.

Collaborators

Not stated in the official study record.

Study type

Interventional study

Phase

Not applicable / observational

Enrollment

60

Start date

12-02-2024

Primary completion date

09-30-2027

Estimated / actual completion date

12-31-2027

Last source update

09-18-2026

What is being studied?

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.

Intervention(s)

Who may be eligible?

This is a simplified summary. The official study team or research center determines eligibility.

Population / disease status

Diagnosed ALS

Diagnosis / conditions

Amyotrophic Lateral Sclerosis (ALS)

Age

18 Years to Not stated in the official study record.

Disease duration

Not stated in the official study record.

Respiratory criteria

The official eligibility criteria include language relevant to this topic; review the full criteria below.

ALSFRS-R criteria

The official eligibility criteria include language relevant to this topic; review the full criteria below.

Genetic criteria

Not stated in the official study record.

Medication requirements

The official eligibility criteria include language relevant to this topic; review the full criteria below.

Major inclusion and exclusion criteria from the official record

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

Genetics

Gene-specific study?

No

Gene or variant

Any / Not gene-specific

Genetic test required?

Not stated in the official study record.

Known carrier required?

Not stated

Confirmed pathogenic variant required?

Not stated in the official study record.

Presymptomatic carriers eligible?

Not stated in the official study record.

At-risk relative eligible?

Not stated

Genetic test provided?

Not stated in the official study record.

Genetic counseling provided?

Not stated in the official study record.

Results returned / offered?

Not stated

Family history required?

Not stated in the official study record.

Study design

Randomized?

Not stated in the official study record.

Allocation

Not stated in the official study record.

Intervention model

Not stated in the official study record.

Masking

Not stated in the official study record.

Placebo

Not stated in the official study record.

Primary purpose

Not stated in the official study record.

Endpoints

Primary outcome measures

• NfL reduction

Secondary outcome measures

• Monthly Progression Rate (MPR)
• New Potential Theranostic Biomarkers Assay
• Effect on resting motor threshold (RMT) and active motor threshold (AMT)
• Effect on motor evoked potentials (MEP) size

A biomarker outcome should not automatically be interpreted as a clinical outcome.

Locations

Contact

Central contact: Not stated in the official study record.