Mobile Transcranial Magnetic Stimulation

NCT06689592 | Completed

• 1 other identifier: 24-3652-101
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Depression

Outcome Measures

Primary Outcomes (6)

• Usability for the patients

  Rating of the usability of the treatment with the user experience questionnaire \[1-7, 26 items, the higher the better\] and open feedback

  1 week

• Usability for the handlers/clinicians

  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

  1 week

• Efficiancy 1

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

  1 week

• Efficiancy 2

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

  1 week

• Stability of effects 1

  Number of responders according the the clinical global impression change score

  5 weeks

• Stability of effects 2

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

  5 weeks

Secondary Outcomes (4)

• 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 WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF)

  1 week

• Course of the scores of the Clincial Global Impression change

  1 week

Study Arms (1)

Mobile Transcranial Magnetic Stimulation

EXPERIMENTAL

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).

Device: Transcranial Magnetic Stimulation

Interventions

Transcranial Magnetic Stimulation DEVICE

Intermittent theta burst stimulation

Mobile Transcranial Magnetic Stimulation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Regensburg: lead

Study Sites (1)

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

Regensburg, Bavaria, 93053, Germany

Location

MeSH Terms

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Berthold Langguth, PhD

  University of Regensburg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, MD, Ph.D.

Study Record Dates

• First Submitted: November 12, 2024
• First Posted: November 14, 2024
• Study Start: August 15, 2024
• Primary Completion: February 28, 2025
• Study Completion: March 31, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)