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

Campus Bio-Medico University of Rome

Status: Unknown

Conditions: Amyotrophic Lateral Sclerosis

Treatments: Device: sham tSMS; Device: tSMS

Study type: Interventional

Funder types: Other

Identifiers

NCT04393467

STIMALS

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 2 patient groups

real tSMS

Experimental group

Description:

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.

Treatment:

Device: tSMS

sham tSMS

Sham Comparator group

Description:

A non-magnetic steel cylinder, with same size, weight and appearance of the magnet, will be used for sham stimulation.

Treatment:

Device: sham tSMS