Transcranial Stimulation for Amyotrophic Lateral Sclerosis
Transcranial Static Magnetic Stimulation (tSMS) and Potential Theranostic Biomarkers in Amyotrophic Lateral Sclerosis.
Recruiting
N/A
Interventional Study
Amyotrophic Lateral Sclerosis (ALS)
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 60 (estimated)
- Sponsor
- Campus Bio-Medico University · Other
Who this trial is looking for
This trial is looking for adults with Amyotrophic Lateral Sclerosis (ALS) to test a new therapy called transcranial static magnetic stimulation (tSMS). Participants will receive treatment at home for 12 months while being monitored through clinical evaluations and tests.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 18 years old.
- I have been diagnosed with ALS.
- My ALS symptoms started less than 24 months ago.
- I have an ALSFRS-R score over 30 when I join.
- My ALSFRS-R score declined by more than 1 point in the last 3 months.
- I have normal breathing function.
- I am taking riluzole.
You may not be able to join if
- I am currently in another clinical trial.
- I have a tracheotomy or am using a feeding tube.
- I can't perform breathing tests due to severe symptoms.
- I have conditions that prevent me from being exposed to magnetic fields.
- I am pregnant or breastfeeding.
- I have a history of seizures or epilepsy.
- I have cognitive impairment.
- I cannot give informed consent.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
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Answer a few quick questions to see if you may meet the eligibility requirements.
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About This Trial
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 …
Trial Locations
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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
* n…
Contacts