Status:
UNKNOWN
Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).
Lead Sponsor:
Campus Bio-Medico University
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This study aims to evaluate safety and efficacy of tSMS in ALS patients and to obtain preliminary data about the effects of tSMS on cortical excitability. To this purpose, 40 ALS patients will be rec...
Eligibility Criteria
Inclusion
- age between 18 and 75 years
- 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
- inclusion in other clinical trials
- 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
Key Trial Info
Start Date :
May 31 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2023
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04393467
Start Date
May 31 2020
End Date
December 1 2023
Last Update
October 19 2020
Active Locations (2)
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1
Department of Neurology and Laboratory of Neuroscience, Istituto Auxologico Italiano, IRCCS
Milan, Italy
2
Neurology Unit, Campus Biomedico University
Rome, Italy, 00128