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

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Campus Bio-Medico University
Send
Updated on 16 February 2024
See if I qualify
antidepressants
excitability
cognitive impairment
epilepsy
riluzole
amyotrophic lateral sclerosis
primary lateral sclerosis
riluzole 50 mg
nervous system
percutaneous endoscopic gastrostomy

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.

Details
Condition Myelopathy, spinal cord disorders, Amyotrophic Lateral Sclerosis, spinal cord disorders
Age 18years - 75years
Treatment tSMS, sham tSMS
Clinical Study IdentifierNCT04393467
SponsorCampus Bio-Medico University
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

antidepressants
excitability
cognitive impairment
epilepsy
riluzole
amyotrophic lateral sclerosis
primary lateral sclerosis
riluzole 50 mg
nervous system
percutaneous endoscopic gastrostomy

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.