Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Campus Bio-Medico University
Updated on 19 February 2024
antidepressants
excitability
cognitive impairment
epilepsy
riluzole
amyotrophic lateral sclerosis
primary lateral sclerosis
riluzole 50 mg
nervous system
percutaneous endoscopic gastrostomy

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 recruited and randomized to real or sham tSMS. After 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.

Details
Condition Myelopathy, spinal cord disorders, Amyotrophic Lateral Sclerosis, spinal cord disorders
Age 18years - 75years
Treatment tSMS, sham tSMS
Clinical Study IdentifierNCT04393467
SponsorCampus Bio-Medico University
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

Inclusion Criteria

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 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

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
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