NCT06834269Active, not recruiting
Transcranial Static Magnetic Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis.
Efficacy of Transcranial Static Magnetic Field Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis (ALS).
Source: ClinicalTrials.gov · Last updated 18 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 14 Feb 2025
- Start date
- 2 Dec 2024
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- Campus Bio-Medico University
- Diseases
- ALS (motor neurone disease)
- NCT number
- NCT06834269
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 2 Dec 2024 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- use of drugs acting on central nervous system, except for antidepressive drugs and benzodiazepines.
Other illness
- history of epilepsy or seizures
- cognitive impairment
Other
- 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
- lack of informed consent
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Campus Bio-Medico Coordinator of this site? Confirm its status | Roma | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.