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

February 26, 2025 updated by: Di Lazzaro Vincenzo, Campus Bio-Medico University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pwALS
All participants will undergo tSMS administration at home, in two daily sessions of 120 minutes each.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NfL reduction
Time Frame: 12 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monthly Progression Rate (MPR)
Time Frame: 15 months
MPR is derived from the comparison between the ALSFRS-R (Revised Amyotrophic Lateral Sclerosis Functional Rating Scale) decline over the period of at least three months before the treatment, and the period of twelve months during the treatment. The ALSFRS-R is 12-items scale ranking from 0 (worse) to 48 (better) points.
15 months
Effect on resting motor threshold (RMT) and active motor threshold (AMT)
Time Frame: 12 months
Change in TMS-derived cortical excitability parameters (RMT and AMT) before and after stimulation period.
12 months
Effect on motor evoked potentials (MEP) size
Time Frame: 12 months
Change in TMS-derived cortical excitability parameters (MEP size) before and after stimulation period.
12 months
New Potential Theranostic Biomarkers Assay
Time Frame: 12 months
Investigation of potential theranostic biomarkers in blood samples (YKL-40, TDP43) and urine samples (p75ECD), collected at baseline and evrey three months during the treatment
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Campus Bio-Medico University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 2, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 14, 2025

First Submitted That Met QC Criteria

February 14, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 26, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • StaticALS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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