Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).
NCT ID: NCT04393467
Last Updated: 2020-10-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
40 participants
INTERVENTIONAL
2020-05-31
2023-12-31
Brief Summary
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To this purpose, 40 ALS patients will be recruited and randomized to real or sham tSMS. After at least 3 months follow-up, they will undergo tSMS, daily for 120 min, at home, for 6 consecutive months.
Clinical status will be tested before, during and after the stimulation period. Moreover, cortical excitability will be tested by transcranial magnetic stimulation (TMS) before and after the stimulation period.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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real tSMS
tSMS will be delivered by a magnet applied to M1, bilaterally (120 min daily, for 6 months). Magnet will be kept in position by a plastic helmet.
tSMS
tSMS delivered on bilateral motor cortex
sham tSMS
A non-magnetic steel cylinder, with same size, weight and appearance of the magnet, will be used for sham stimulation.
sham tSMS
sham tSMS delivered on bilateral motor cortex by a non-magnetic steel cylinder, with same size, weight and appearance of the magnet used for real tSMS
Interventions
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tSMS
tSMS delivered on bilateral motor cortex
sham tSMS
sham tSMS delivered on bilateral motor cortex by a non-magnetic steel cylinder, with same size, weight and appearance of the magnet used for real tSMS
Eligibility Criteria
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Inclusion Criteria
* diagnosis of 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 (FVC \> 80% and ALSFRS-R items 10,11,12 \> 4) at the recruitment
* treatment with riluzole 50 mg x 2/die
Exclusion Criteria
* presence of tracheotomy or/and PEG (percutaneous endoscopic gastrostomy)
* contraindications to magnetic fields exposure
* pregnancy or breast-feeding
* history of epilepsy or seizures
* assumption of drugs acting on central nervous system, except for antidepressive drugs and benzodiazepines.
* cognitive impairment
* lack of informed consent
18 Years
75 Years
ALL
No
Sponsors
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Campus Bio-Medico University
OTHER
Responsible Party
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Di Lazzaro Vincenzo
Full Professor of Neurology
Locations
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Department of Neurology and Laboratory of Neuroscience, Istituto Auxologico Italiano, IRCCS
Milan, , Italy
Neurology Unit, Campus Biomedico University
Rome, , Italy
Countries
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Facility Contacts
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References
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Di Lazzaro V, Ranieri F, Doretti A, Boscarino M, Maderna L, Colombo E, Soranna D, Zambon A, Ticozzi N, Musumeci G, Capone F, Silani V. Transcranial static magnetic stimulation for amyotrophic lateral sclerosis: a bicentric, randomised, double-blind placebo-controlled phase 2 trial. Lancet Reg Health Eur. 2024 Jul 30;45:101019. doi: 10.1016/j.lanepe.2024.101019. eCollection 2024 Oct.
Other Identifiers
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STIMALS
Identifier Type: -
Identifier Source: org_study_id
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