Transcranial Static Magnetic Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcranial magnetic stimulation (tSMS).
- Who it may be relevant to
- Registry conditions: Amyotrophic Lateral Sclerosis (ALS). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy of Transcranial Static Magnetic Field Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis (ALS).
Overview
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.
Interventions
- 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.
Primary outcome measures
- NfL reduction [Time frame: 12 months]
Secondary outcome measures (4)
- Monthly Progression Rate (MPR) [Time frame: 15 months]
- New Potential Theranostic Biomarkers Assay [Time frame: 12 months]
- Effect on resting motor threshold (RMT) and active motor threshold (AMT) [Time frame: 12 months]
- Effect on motor evoked potentials (MEP) size [Time frame: 12 months]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 1 center
- Fondazione Policlinico Campus Bio-Medico — Roma
Identifiers
NCT: NCT06834269 · StaticALS