Mobile Transcranial Magnetic Stimulation

Not Applicable

Recruiting

• Conditions: Depression

• Registration Number: NCT06689592
• Lead Sponsor: University of Regensburg

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.

Study Timeline

• Study Start: 2024-08-15
• Status Verified: 2024-11
• Study First Submitted: 2024-11-12
• Study First Submitted QC: 2024-11-12
• Study First Posted: 2024-11-14
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22
• Primary Completion: 2025-06-30
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Usability for the patients	1 week	Rating of the usability of the treatment with the user experience questionnaire \[1-7, 26 items, the higher the better\] and open feedback
Usability for the handlers/clinicians	1 week	Rating of the usability of the treatment (home treatment) with the user experience questionnaire \[1-7, 26 items, the higher the better\] and open feedback
Efficiancy 1	1 week	Number of responders according the the clinical global impression change score for patients in the per protocol analysis
Efficiancy 2	1 week	Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items)
Stability of effects 1	5 weeks	Number of responders according the the clinical global impression change score
Stability of effects 2	5 weeks	Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items)

Secondary Outcome Measures

Name	Time	Method
Course of the scores of the Clincial Global Impression change	1 week	Clincial Global Impression (1-7, the lower the better)
Course of the scores of the Hamilton depression rating scale	1 week	Depression rating scale (0-65, the lower the better)
Course of the scores of the Major Depression Inventory	1 week	Depression inventory (0-50, the lower the better)
Course of the scores of the WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF)	1 week	Quality of life scale inventory (4-20, the higher the better)

Trial Locations

Locations (1)

Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany; 🇩🇪 Regensburg, Bavaria, Germany