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

Not Applicable

• Conditions: Amyotrophic Lateral Sclerosis

• Registration Number: NCT04393467
• Lead Sponsor: Campus Bio-Medico University

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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-13
• Study First Submitted QC: 2020-05-16
• Study First Posted: 2020-05-19
• Study Start: 2020-05-31
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-14
• Last Update Posted: 2020-10-19
• Primary Completion: 2023-05
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Disease progression	9 months	Comparison between the ALSFRS-R (Revised Amyotrophic Lateral Sclerosis Functional Rating Scale) decline over the period of at least three months before the treatment and the period of six months during the treatment. The ALSFRS-R is 12-items scale ranking from 0 (worse) to 48 (better) points.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability	6 months	Incidence of adverse events during the stimulation period
Compliance	6 months	Number of stimulation sessions actually completed by each patient
Effect on motor evoked potentials (MEP) size	6 months	Change in TMS-derived cortical excitability parameters (MEP size) before and after stimulation period.
Effect on resting motor threshold (RMT) and active motor threshold (AMT)	6 months	Change in TMS-derived cortical excitability parameters (RMT and AMT) before and after stimulation period.

Trial Locations

Locations (2)

Department of Neurology and Laboratory of Neuroscience, Istituto Auxologico Italiano, IRCCS; 🇮🇹 Milan, Italy

Neurology Unit, Campus Biomedico University; 🇮🇹 Rome, Italy