Mobile Transcranial Magnetic Stimulation

NCT ID: NCT06689592

Last Updated: 2025-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2025-03-31

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.

Conditions

Depression

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mobile Transcranial Magnetic Stimulation

Transcranial Magnetic Stimulation at home. Half of the SAINT protocol (Cole et al., 2020, 2022) is to be carried out. For this purpose, all 5 test subjects are treated with 5 sessions per day on 5 consecutive days (25 stimulations in total). An iTBS protocol (3 pulses at 50 Hz in 2 seconds, 8 seconds pause) with 1800 pulses (total duration: 10 minutes) should be used every hour with a break of 50 minutes (total of 9,000 pulses can be applied per day).

Group Type: EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type: DEVICE

Intermittent theta burst stimulation

Interventions

Transcranial Magnetic Stimulation

Intermittent theta burst stimulation

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Regensburg

OTHER

Sponsor Role: lead

Responsible Party

Berthold Langguth, MD, Ph.D.

Clinical Professor, MD, Ph.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Berthold Langguth, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg

Locations

Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany

Regensburg, Bavaria, Germany

Countries

Germany

Other Identifiers

24-3652-101

Identifier Type: -

Identifier Source: org_study_id