Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).
Primary Purpose
Amyotrophic Lateral Sclerosis
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
tSMS
sham tSMS
Sponsored by
About this trial
This is an interventional treatment trial for Amyotrophic Lateral Sclerosis focused on measuring Amyotrophic Lateral Sclerosis, ALS, transcranial magnetic stimulation, static magnetic field, tSMS
Eligibility 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 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
Sites / Locations
- Department of Neurology and Laboratory of Neuroscience, Istituto Auxologico Italiano, IRCCSRecruiting
- Neurology Unit, Campus Biomedico UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
real tSMS
sham tSMS
Arm 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.
A non-magnetic steel cylinder, with same size, weight and appearance of the magnet, will be used for sham stimulation.
Outcomes
Primary Outcome Measures
Disease progression
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 Outcome Measures
Safety and tolerability
Incidence of adverse events during the stimulation period
Compliance
Number of stimulation sessions actually completed by each patient
Effect on resting motor threshold (RMT) and active motor threshold (AMT)
Change in TMS-derived cortical excitability parameters (RMT and AMT) before and after stimulation period.
Effect on motor evoked potentials (MEP) size
Change in TMS-derived cortical excitability parameters (MEP size) before and after stimulation period.
Full Information
NCT ID
NCT04393467
First Posted
May 13, 2020
Last Updated
October 14, 2020
Sponsor
Campus Bio-Medico University
1. Study Identification
Unique Protocol Identification Number
NCT04393467
Brief Title
Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).
Official Title
Efficacy of Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2020 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amyotrophic Lateral Sclerosis
Keywords
Amyotrophic Lateral Sclerosis, ALS, transcranial magnetic stimulation, static magnetic field, tSMS
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
real tSMS
Arm Type
Experimental
Arm 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.
Arm Title
sham tSMS
Arm Type
Sham Comparator
Arm Description
A non-magnetic steel cylinder, with same size, weight and appearance of the magnet, will be used for sham stimulation.
Intervention Type
Device
Intervention Name(s)
tSMS
Intervention Description
tSMS delivered on bilateral motor cortex
Intervention Type
Device
Intervention Name(s)
sham tSMS
Intervention Description
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 Measure Information:
Title
Disease progression
Description
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.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Safety and tolerability
Description
Incidence of adverse events during the stimulation period
Time Frame
6 months
Title
Compliance
Description
Number of stimulation sessions actually completed by each patient
Time Frame
6 months
Title
Effect on resting motor threshold (RMT) and active motor threshold (AMT)
Description
Change in TMS-derived cortical excitability parameters (RMT and AMT) before and after stimulation period.
Time Frame
6 months
Title
Effect on motor evoked potentials (MEP) size
Description
Change in TMS-derived cortical excitability parameters (MEP size) before and after stimulation period.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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 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
Facility Information:
Facility Name
Department of Neurology and Laboratory of Neuroscience, Istituto Auxologico Italiano, IRCCS
City
Milan
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincenzo Silani, MD
Phone
+39 02619111
Email
vincenzo.silani@unimi.it
Facility Name
Neurology Unit, Campus Biomedico University
City
Rome
ZIP/Postal Code
00128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincenzo Di Lazzaro, MD
Phone
+39 06 22541 1320
Email
v.dilazzaro@unicampus.it
First Name & Middle Initial & Last Name & Degree
Fioravante Capone, PhD
First Name & Middle Initial & Last Name & Degree
Marilisa Boscarino, MD
12. IPD Sharing Statement
Plan to Share IPD
No
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Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).
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