NCT04393467

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 13, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 19, 2020

Completed
12 days until next milestone

Study Start

First participant enrolled

May 31, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

October 19, 2020

Status Verified

October 1, 2020

Enrollment Period

2.9 years

First QC Date

May 13, 2020

Last Update Submit

October 14, 2020

Conditions

Amyotrophic Lateral Sclerosis

Keywords

Amyotrophic Lateral SclerosisALStranscranial magnetic stimulationstatic magnetic fieldtSMS

Outcome Measures

Primary Outcomes (1)

  • 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.

    9 months

Secondary Outcomes (4)

  • Safety and tolerability

    6 months

  • Compliance

    6 months

  • Effect on resting motor threshold (RMT) and active motor threshold (AMT)

    6 months

  • Effect on motor evoked potentials (MEP) size

    6 months

Study Arms (2)

real tSMS

EXPERIMENTAL

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

sham tSMS

SHAM COMPARATOR

A non-magnetic steel cylinder, with same size, weight and appearance of the magnet, will be used for sham stimulation.

Device: sham tSMS

Interventions

tSMSDEVICE

tSMS delivered on bilateral motor cortex

real tSMS
sham tSMSDEVICE

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

sham tSMS

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Department of Neurology and Laboratory of Neuroscience, Istituto Auxologico Italiano, IRCCS

Milan, Italy

RECRUITING

Neurology Unit, Campus Biomedico University

Rome, 00128, Italy

RECRUITING

Related Publications (1)

  • Di Lazzaro V, Ranieri F, Doretti A, Boscarino M, Maderna L, Colombo E, Soranna D, Zambon A, Ticozzi N, Musumeci G, Capone F, Silani V. Transcranial static magnetic stimulation for amyotrophic lateral sclerosis: a bicentric, randomised, double-blind placebo-controlled phase 2 trial. Lancet Reg Health Eur. 2024 Jul 30;45:101019. doi: 10.1016/j.lanepe.2024.101019. eCollection 2024 Oct.

    PMID: 39185360DERIVED

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor of Neurology

Study Record Dates

First Submitted

May 13, 2020

First Posted

May 19, 2020

Study Start

May 31, 2020

Primary Completion

May 1, 2023

Study Completion

December 1, 2023

Last Updated

October 19, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)