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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04393467

Enrollment

Registered

2020-05-19

Start date

2020-05-31

Completion date

2023-12-31

Last updated

2020-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral Sclerosis, ALS, transcranial magnetic stimulation, static magnetic field, tSMS

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.

Interventions

DEVICEtSMS

tSMS delivered on bilateral motor cortex

DEVICEsham 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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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.
Effect on motor evoked potentials (MEP) size	6 months	Change in TMS-derived cortical excitability parameters (MEP size) before and after stimulation period.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026