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NCT Number: NCT06834269

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

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.

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Key information

Conditions

Amyotrophic Lateral Sclerosis (ALS) Amyotrophic Lateral Sclerosis Central Nervous System Diseases Metabolic Diseases Motor Neuron Disease Nervous System Diseases Neurodegenerative Diseases Neuromuscular Diseases Nutritional and Metabolic Diseases Proteostasis Deficiencies Spinal Cord Diseases TDP-43 Proteinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondazione Policlinico Campus Bio-Medico

Roma, RM, 00128, Italy

Location status: Recruiting

Location contact

Vincenzo Di Lazzaro

CONTACT

[email protected]

06 22541 1220

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Vincenzo Di Lazzaro

CONTACT

[email protected]

06 22541 1220

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Feb 19, 2025
Registry last updated
Feb 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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