Study Purpose:
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 Status:
Recruiting
Disease:
Amyotrophic Lateral Sclerosis
Study Type:
Interventional
Type of Intervention:
Device
Intervention Name:
tSMS, sham tSMS
Placebo:
Phase:
N/A
Study Chair(s)/Principal Investigator(s):
N/A
Clinicaltrials.gov ID:
Neals Affiliated?
No
Coordinating Center Contact Information
Study Sponsor:
Campus Bio-Medico University
Estimated Enrollment:
40
Estimated Study Start Date:
05 / 31 / 2020
Estimated Study Completion Date:
12 / 01 / 2023
Posting Last Modified Date:
10 / 19 / 2020
Date Study Added to neals.org:
05 / 19 / 2020
Minimum Age:
18 Years
Maximum Age:
75 Years
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
Department of Neurology and Laboratory of Neuroscience, Istituto Auxologico Italiano, IRCCS | Recruiting
Vincenzo Silani, MD / +39 02619111 / email hidden; JavaScript is required
Milan
Italy
Neurology Unit, Campus Biomedico University | Recruiting
Vincenzo Di Lazzaro, MD / +39 06 22541 1320 / email hidden; JavaScript is required
Sub-Investigator : Marilisa Boscarino, MD
Rome 00128
Italy