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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Amyotrophic Lateral Sclerosis
• Intervention / Treatment: Device: tSMS; Device: sham tSMS

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • Department of Neurology and Laboratory of Neuroscience, Istituto Auxologico Italiano, IRCCS
    • Contact: Vincenzo Silani, MD; Phone Number: +39 02619111; Email: vincenzo.silani@unimi.it
  • Rome, Italy, 00128
    • Recruiting
    • Neurology Unit, Campus Biomedico University
    • Contact: Vincenzo Di Lazzaro, MD; Phone Number: +39 06 22541 1320; Email: v.dilazzaro@unicampus.it
    • Principal Investigator: Fioravante Capone, PhD
    • Sub-Investigator: Marilisa Boscarino, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: tSMS; tSMS delivered on bilateral motor cortex
Sham Comparator: sham tSMS; A non-magnetic steel cylinder, with same size, weight and appearance of the magnet, will be used for sham stimulation.	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease progression	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.	9 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Campus Bio-Medico University

Study record dates

Study Major Dates

• Study Start (Actual): May 31, 2020
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: May 16, 2020
• First Posted (Actual): May 19, 2020

Study Record Updates

• Last Update Posted (Actual): October 19, 2020
• Last Update Submitted That Met QC Criteria: October 14, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Amyotrophic Lateral Sclerosis; ALS; transcranial magnetic stimulation; static magnetic field; tSMS
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Central Nervous System Diseases; Nervous System Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Sclerosis; Motor Neuron Disease; Amyotrophic Lateral Sclerosis
• Other Study ID Numbers: STIMALS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No