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临床试验/NCT06689592
NCT06689592已完成不适用

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

University of Regensburg2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2024年8月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
5
试验地点
2
主要终点
Usability for the patients

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Usability for the patients

时间窗: 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

时间窗: 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

时间窗: 1 week

Number of responders according the the clinical global impression change score for patients in the per protocol analysis

Efficiancy 2

时间窗: 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

时间窗: 5 weeks

Number of responders according the the clinical global impression change score

Stability of effects 2

时间窗: 5 weeks

Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items)

次要结局

  • Course of the scores of the Hamilton depression rating scale(1 week)
  • Course of the scores of the Major Depression Inventory(1 week)
  • Course of the scores of the Clincial Global Impression change(1 week)
  • Course of the scores of the WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF)(1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Berthold Langguth, MD, Ph.D.

Clinical Professor, MD, Ph.D.

University of Regensburg

研究点 (2)

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