Trials / Unknown
UnknownNCT04393467
Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).
Efficacy of Transcranial Static Magnetic Field Stimulation (tSMS) in Amyotrophic Lateral Sclerosis (ALS).
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Campus Bio-Medico University · Academic / Other
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | tSMS | tSMS delivered on bilateral motor cortex |
| DEVICE | sham tSMS | 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 |
Timeline
- Start date
- 2020-05-31
- Primary completion
- 2023-05-01
- Completion
- 2023-12-01
- First posted
- 2020-05-19
- Last updated
- 2020-10-19
Locations
2 sites across 1 country: Italy
Source: ClinicalTrials.gov record NCT04393467. Inclusion in this directory is not an endorsement.