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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
Sponsor:
Information provided by (Responsible Party):
Di Lazzaro Vincenzo, Campus Bio-Medico University

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 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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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


Arm Intervention/treatment
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.
Device: tSMS
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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Safety and tolerability [ Time Frame: 6 months ]
    Incidence of adverse events during the stimulation period

  2. Compliance [ Time Frame: 6 months ]
    Number of stimulation sessions actually completed by each patient

  3. 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.

  4. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04393467


Locations
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Italy
Department of Neurology and Laboratory of Neuroscience, Istituto Auxologico Italiano, IRCCS Recruiting
Milan, Italy
Contact: Vincenzo Silani, MD    +39 02619111    vincenzo.silani@unimi.it   
Neurology Unit, Campus Biomedico University Recruiting
Rome, Italy, 00128
Contact: Vincenzo Di Lazzaro, MD    +39 06 22541 1320    v.dilazzaro@unicampus.it   
Principal Investigator: Fioravante Capone, PhD         
Sub-Investigator: Marilisa Boscarino, MD         
Sponsors and Collaborators
Campus Bio-Medico University
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Responsible Party: Di Lazzaro Vincenzo, Full Professor of Neurology, Campus Bio-Medico University
ClinicalTrials.gov Identifier: NCT04393467    
Other Study ID Numbers: STIMALS
First Posted: May 19, 2020    Key Record Dates
Last Update Posted: May 19, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Di Lazzaro Vincenzo, Campus Bio-Medico University:
Amyotrophic Lateral Sclerosis
ALS
transcranial magnetic stimulation
static magnetic field
tSMS
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases