Actively Recruiting
Transcranial Static Magnetic Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis.
Led by Campus Bio-Medico University · Updated on 2025-02-28
60
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Transcranial Static Magnetic Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years of age or older
- Diagnosed with possible, probable, or definite ALS according to revised El Escorial and Awaji-Shima criteria
- Disease duration less than 24 months
- ALS Functional Rating Scale-Revised (ALSFRS-R) score greater than 30 at recruitment
- ALSFRS-R decline greater than 1 in the at least 3-month period before intervention
- Normal respiratory function in preliminary evaluation with FVC 75% or higher and ALSFRS-R items 10, 11, and 12 greater than 4
- Treatment with riluzole 50 mg twice daily
You will not qualify if you...
- Participation in other clinical trials
- Presence of tracheotomy or percutaneous endoscopic gastrostomy (PEG)
- Unable to perform spirometry due to severe bulbar involvement
- Contraindications to magnetic field exposure
- Pregnancy or breastfeeding
- History of epilepsy or seizures
- Use of central nervous system drugs except antidepressants and benzodiazepines
- Cognitive impairment
- Lack of informed consent
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Campus Bio-Medico
Roma, RM, Italy, 00128
Actively Recruiting
Research Team
V
Vincenzo Di Lazzaro
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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