NCT06689592

Mobile Transcranial Magnetic Stimulation

Untersuchung Der Durchführbarkeit Von TMS-Behandlungen Zuhause - Mobile Transkranielle Magnetstimulation "MTMS"

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: University of Regensburg · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

For this study 5 patients will be treated with transcranial magnetic stimulation in their residence (home, nursing home).

Detailed description

An investigation of the feasibility of rTMS treatments outside a clinical-medical context (e.g. in a residential facility and/or at the patient's home) is to be carried out (5 patients in total). Before the actual start of the study, the test subjects are informed in detail about the experimental setup and the methods used, as well as about contraindications and possible side effects. Following the information session, the test subjects sign a declaration of consent and complete questionnaires with relevant information (demographic data, health data to rule out serious illnesses and diagnostic questionnaires). On this day, a TMS test with a few test pulses is also planned in order to familiarize the test subjects with the TMS and to evaluate their tolerance. The stimulation intensity (so-called motor threshold) is also determined as part of this. In the following week, the TMS treatment is carried out on 5 consecutive days with a further visit. Following the preparations, a protocol modified from the Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT) protocol is carried out. For this purpose, the test subjects are treated in 5 sessions per day on 5 consecutive days (25 stimulations in total). An iTBS protocol (3 bursts at 50 Hz in 2 seconds, 8 second pause) with 1800 pulses should be used every hour, which means that the duration of a stimulation is approximately 10 minutes and a total of 9,000 pulses could be applied per day. The individual sessions are monitored by a Medbo Regensburg employee on site. There should be a break of 50 minutes between each hourly stimulation. After the treatment, a follow-up should take place after 4 weeks with questionnaires and a short verbal evaluation. Each subject can voluntarily terminate participation in the study at any time without giving reasons and without negative consequences (except for the lack of treatment). If the participant's compliance is severely impaired, the study may be terminated by the investigator.

Conditions

• Depression

Interventions

Type	Name	Description
DEVICE	Transcranial Magnetic Stimulation	Intermittent theta burst stimulation

Timeline

• Start date: 2024-08-15
• Primary completion: 2025-02-28
• Completion: 2025-03-31
• First posted: 2024-11-14
• Last updated: 2025-04-15

Locations

1 site across 1 country: Germany