Amyotrophic Lateral Sclerosis (ALS)NCT06834269
Transcranial Static Magnetic Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis.
A study testing Transcranial magnetic stimulation (tSMS) in people with Amyotrophic Lateral Sclerosis (ALS), run by Campus Bio-Medico University at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amyotrophic Lateral Sclerosis (ALS)
- What is being tested?
- Transcranial magnetic stimulation (tSMS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 2 Dec 2024to 31 Dec 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- treatment with riluzole 50 mg x 2/die
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Transcranial Static Magnetic Field Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis (ALS).
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
- Amyotrophic Lateral Sclerosis (ALS)
- Being tested
- Transcranial magnetic stimulation (tSMS)
- Keywords
- Amyothrophic Lateral Sclerosis, ALS, tSMS, transcranial magnetic stimulation, NF-L, YKL-40, p75ECD, Biomarkers, transcranial static magnetic stimulation, TDP43
- Medical subject headings
- Amyotrophic Lateral Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| pwALS | Experimental | All participants will undergo tSMS administration at home, in two daily sessions of 120 minutes each. Receives: Device: Transcranial magnetic stimulation (tSMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
NfL reduction
The potential reduction of NfL during treatment is monitored by blood samples collected at baseline, and then , every 3 months during the treatment
Measured: 12 months
Secondary outcomes (4)
Monthly Progression Rate (MPR)
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.
Measured: 15 months
New Potential Theranostic Biomarkers Assay
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
Measured: 12 months
Effect on resting motor threshold (RMT) and active motor threshold (AMT)
Change in TMS-derived cortical excitability parameters (RMT and AMT) before and after stimulation period.
Measured: 12 months
Effect on motor evoked potentials (MEP) size
Change in TMS-derived cortical excitability parameters (MEP size) before and after stimulation period.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2025
- Study start2 Dec 2024
- Primary completion30 Sep 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amyotrophic Lateral Sclerosis (ALS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Di Lazzaro Vincenzo, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06834269
- Sponsor's protocol ID
- StaticALS
- Status last verified
- Sep 2026
- First submitted
- 14 Feb 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided