Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04393467|
Recruitment Status : Recruiting
First Posted : May 19, 2020
Last Update Posted : May 19, 2020
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 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.
|Condition or disease||Intervention/treatment||Phase|
|Amyotrophic Lateral Sclerosis||Device: tSMS Device: sham tSMS||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Efficacy of Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).|
|Estimated Study Start Date :||May 2020|
|Estimated Primary Completion Date :||May 2023|
|Estimated Study Completion Date :||December 2023|
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.
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
- Disease progression [ Time Frame: 9 months ]Comparison between the ALSFRS-R (Revised Amyotrophic Lateral Sclerosis Functional Rating Scale) decline over the period of 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.
- Safety and tolerability [ Time Frame: 6 months ]Incidence of adverse events during the stimulation period
- Compliance [ Time Frame: 6 months ]Number of stimulation sessions actually completed by each patient
- Effect on resting motor threshold (RMT) and active motor threshold (AMT) [ Time Frame: 6 months ]Change in TMS-derived cortical excitability parameters (RMT and AMT) before and after stimulation period.
- Effect on motor evoked potentials (MEP) size [ Time Frame: 6 months ]Change in TMS-derived cortical excitability parameters (MEP size) before and after stimulation period.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393467
|Department of Neurology and Laboratory of Neuroscience, Istituto Auxologico Italiano, IRCCS||Recruiting|
|Contact: Vincenzo Silani, MD +39 02619111 email@example.com|
|Neurology Unit, Campus Biomedico University||Recruiting|
|Rome, Italy, 00128|
|Contact: Vincenzo Di Lazzaro, MD +39 06 22541 1320 firstname.lastname@example.org|
|Principal Investigator: Fioravante Capone, PhD|
|Sub-Investigator: Marilisa Boscarino, MD|