Clinical trial NCT06834269: Transcranial Static Magnetic Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis.
Official title: Efficacy of Transcranial Static Magnetic Field Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis (ALS).
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2025-02-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: NfL reduction
timeFrame: 12 months
Secondary outcomes:
measure: Monthly Progression Rate (MPR)
timeFrame: 15 months
measure: New Potential Theranostic Biomarkers Assay
timeFrame: 12 months
measure: Effect on resting motor threshold (RMT) and active motor threshold (AMT)
timeFrame: 12 months
measure: Effect on motor evoked potentials (MEP) size
timeFrame: 12 months
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Campus Bio-Medico
state: RM
Study officials:
References: