DepressionMTMSNCT06689592
Mobile Transcranial Magnetic Stimulation
A study testing Transcranial Magnetic Stimulation in people with Depression, run by University of Regensburg at 1 site in Germany.
Trial summary
For this study 5 patients will be treated with transcranial magnetic stimulation in their residence (home, nursing home). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Depression
- What is being tested?
- Transcranial Magnetic Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- 15 Aug 2024to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, University of Regensburg, Regensburg, Germany
Regensburg, Bavaria, 93053
About this study
Official title: Untersuchung Der Durchführbarkeit Von TMS-Behandlungen Zuhause - Mobile Transkranielle Magnetstimulation "MTMS"
For this study 5 patients will be treated with transcranial magnetic stimulation in their residence (home, nursing home).
Read the 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
- Being tested
- Transcranial Magnetic Stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Magnetic StimulationDevice
Intermittent theta burst stimulation
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Device: Transcranial Magnetic Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 1 week
Efficiancy 1
Number of responders according the the clinical global impression change score for patients in the per protocol analysis
Measured: 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)
Measured: 1 week
Stability of effects 1
Number of responders according the the clinical global impression change score
Measured: 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)
Measured: 5 weeks
Secondary outcomes (4)
Course of the scores of the Hamilton depression rating scale
Depression rating scale (0-65, the lower the better)
Measured: 1 week
Course of the scores of the Major Depression Inventory
Depression inventory (0-50, the lower the better)
Measured: 1 week
Course of the scores of the WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF)
Quality of life scale inventory (4-20, the higher the better)
Measured: 1 week
Course of the scores of the Clincial Global Impression change
Clincial Global Impression (1-7, the lower the better)
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start15 Aug 2024
- Primary completion28 Feb 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Regensburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Berthold Langguth, MD, Ph.D., University of Regensburg
- Investigators
- Berthold Langguth, PhD, Principal investigator, University of Regensburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689592
- Sponsor's protocol ID
- 24-3652-101
- Acronym
- MTMS
- Status last verified
- Apr 2025
- First submitted
- 12 Nov 2024
- Last updated
- 15 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Untersuchung Der Durchführbarkeit Von TMS-Behandlungen Zuhause - Mobile Transkranielle Magnetstimulation "MTMS"
- ClinicalTrials.gov ID
- NCT06689592
- Acronym / sponsor ID
- MTMS / 24-3652-101
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- 15 Aug 2024 (actual)
- Primary completion
- 28 Feb 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 14 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile Transcranial Magnetic Stimulation | Experimental | Device: Transcranial Magnetic StimulationTranscranial 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Magnetic StimulationIntermittent theta burst stimulation | Device | Mobile Transcranial Magnetic Stimulation |
Primary outcome
Usability for the patients
Time frame: 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
Time frame: 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
Time frame: 1 week
Number of responders according the the clinical global impression change score for patients in the per protocol analysis
Efficiancy 2
Time frame: 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
Time frame: 5 weeks
Number of responders according the the clinical global impression change score
Stability of effects 2
Time frame: 5 weeks
Effect size for change of depressivity for patients in the per protocol analysis measured with the Hamilton depression rating scale (21 items)
4 secondary outcomes
Course of the scores of the Hamilton depression rating scale
Time frame: 1 week
Course of the scores of the Major Depression Inventory
Time frame: 1 week
Course of the scores of the WHO Quality of life scale (abbreviated Version) (WHOQOL-BREF)
Time frame: 1 week
Course of the scores of the Clincial Global Impression change
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berthold Langguth, PhD principal investigator
University of Regensburg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Magnetic Stimulation in people with Depression, run by University of Regensburg at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability for the patients (time frame: 1 week). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2025.