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

Last updated: October 14, 2020
Sponsor: Campus Bio-Medico University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Scar Tissue

Amyotrophic Lateral Sclerosis (Als)

Myasthenia Gravis (Chronic Weakness)

Treatment

N/A

Clinical Study ID

NCT04393467
STIMALS
  • Ages 18-75
  • All Genders

Study 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 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.

Eligibility Criteria

Inclusion

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 at least 3-months period before the intervention

  • normal respiratory functionality (FVC > 80% and ALSFRS-R items 10,11,12 > 4) at therecruitment

  • treatment with riluzole 50 mg x 2/die

Exclusion

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 drugsand benzodiazepines.

  • cognitive impairment

  • lack of informed consent

Study Design

Total Participants: 40
Study Start date:
May 31, 2020
Estimated Completion Date:
December 31, 2023

Connect with a study center

  • Department of Neurology and Laboratory of Neuroscience, Istituto Auxologico Italiano, IRCCS

    Milan,
    Italy

    Active - Recruiting

  • Neurology Unit, Campus Biomedico University

    Rome, 00128
    Italy

    Active - Recruiting

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