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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
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
May 13, 2020
Last Updated
October 14, 2020
Sponsor
Campus Bio-Medico University
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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

Learn more about this trial

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

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