Ignite Creation Date:
2025-12-25 @ 12:43 AM
Ignite Modification Date:
2025-12-29 @ 10:34 AM
Study NCT ID:
NCT04393467
Status:
UNKNOWN
Last Update Posted:
2020-10-19
First Post:
2020-05-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).
Sponsor:
Campus Bio-Medico University
Organization:
Study Overview
Official Title:
Efficacy of Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: