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

Amyotrophic Lateral Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04393467
• Other study ID #: STIMALS
• Status: Recruiting
• Phase: N/A
• Start date: May 31, 2020
• Est. completion date: December 2023

Study information

• Verified date: October 2020
• Source: Campus Bio-Medico University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Motor Neuron Disease
• Sclerosis

Intervention

Device:
• tSMS
tSMS delivered on bilateral motor cortex
• 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

Locations

Country	Name	City	State
Italy	Department of Neurology and Laboratory of Neuroscience, Istituto Auxologico Italiano, IRCCS	Milan
Italy	Neurology Unit, Campus Biomedico University	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Campus Bio-Medico University

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Safety and tolerability	Incidence of adverse events during the stimulation period	6 months
Secondary	Compliance	Number of stimulation sessions actually completed by each patient	6 months
Secondary	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
Secondary	Effect on motor evoked potentials (MEP) size	Change in TMS-derived cortical excitability parameters (MEP size) before and after stimulation period.	6 months