Clinical trial NCT06689592: Mobile Transcranial Magnetic Stimulation
Official title: Untersuchung Der Durchführbarkeit Von TMS-Behandlungen Zuhause - Mobile Transkranielle Magnetstimulation "MTMS"
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University of Regensburg
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

* leading diagnosis of a depressive episode according to ICD-10 in the context of a uni- or bipolar disorder
* moderate depression according to the Hamilton Depression Rating Scale
* adult persons aged 18-80 of all genders
* place of residence in Germany and understanding of the German language sufficient to understand the information
* written declaration of consent

Exclusion Criteria:

* Fulfillment of the contraindications for TMS (electrical implants or metallic objects in the body such as pacemakers or insulin pumps, skin diseases on the head)
* The presence of a serious neurological disease (e.g. cerebrovascular events, neurodegenerative diseases, epilepsy, brain malformation, severe head injuries in the medical history)
* Participation in another study during the treatment
* Pregnancy and breastfeeding period

Primary outcomes:
measure: Usability for the patients
timeFrame: 1 week
measure: Usability for the handlers/clinicians
timeFrame: 1 week
measure: Efficiancy 1
timeFrame: 1 week
measure: Efficiancy 2
timeFrame: 1 week
measure: Stability of effects 1
timeFrame: 5 weeks
measure: Stability of effects 2
timeFrame: 5 weeks
Secondary outcomes:
measure: Course of the scores of the Hamilton depression rating scale
timeFrame: 1 week
measure: Course of the scores of the Major Depression Inventory
timeFrame: 1 week
measure: Course of the scores of the WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF)
timeFrame: 1 week
measure: Course of the scores of the Clincial Global Impression change
timeFrame: 1 week
Other outcomes:
Locations:
city: Regensburg
country: Germany
facility: Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany
state: Bavaria
Study officials:
affiliation: University of Regensburg
name: Berthold Langguth, PhD
role: PRINCIPAL_INVESTIGATOR
References: