DepressionneuronaviTBSNCT03953521
Neuronavigated TBS in Depression
A study testing intermittent Theta burst stimulation in people with Depression, run by University of Regensburg at 1 site in Germany.
Trial summary
In this randomized controlled trial we will treat 80 patients with depression with intermittent theta burst stimulation in two parallel arms. Both arms are active interventions differing with respect to positioning of the treatment coil - one arm with neuronavigation and one arm with targeting according to EEG… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Depression
- What is being tested?
- intermittent Theta burst stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2019to 27 May 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unipolar or bipoloar depressive Episode according to ICD-10
- at least moderate Depression according to Hamilton Depression Rating Scale or ICD-10
- if applicable stable medication with psychoactive compounds for out-patients
- if applicable no or stable Treatment for Depression during the course of the Trial
- residence in Germany and mother tongue German
- written informed consent
Who cannot join
- Meeting the contraindications for transcranial magnetic Stimulation or magnetic resonance Imaging (electic devices or metal implants in the Body, e.g. cardiac pace maker, Insulin ppump)
- neurological disorders (e.g. cerebrovascular Events, neurodegenerative disorder, epilepsy, brain malformation, severe head Trauma)
- addictive disorder with consumption in the last two years
- regular intake of benzodiazepines
- participation in another study parallel to the Trial
- pregnancy or breastfeading period
- psychiatric confinement
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Psychiatry and Psychotherapy, University of Regensburg
Regensburg, 93055
About this study
Official title: Neuronavigated Theta Burst Stimulation in Depression
In this randomized controlled trial we will treat 80 patients with depression with intermittent theta burst stimulation in two parallel arms. Both arms are active interventions differing with respect to positioning of the treatment coil - one arm with neuronavigation and one arm with targeting according to EEG Position representing the left dorsolateral prefrontal cortex. Randomisation will be balanced for in- and out-patients and for the treatment arms.
Read the detailed description
Intermittent Theta burst Stimulation (iTBS) is a specific type of repetitive transcranial magnetic Stimulation (rTMS). rTMS of the left prefrontal cortex was shown to be effective in the treatment of Depression. Recent studies showed that iTBS probably is as effective as rTMS.
One possibility to increase to efficacy of rTMS/iTBS is to use neuronavigation. With neuronavigation the coil Position can be targeted with an accuracy in the range of millimeters. Furthermore the Stimulation Position can be ensured during one single session and over the course of the daily Treatments.
The aim of the present study is to investigate the benefit of neuronavigation in the Treatment of Depression with iTBS by using two arms one with targeting the Stimulation site with neuronavigation and one by using the EEG Position F3 as target by using head caps for marking the position.
- Conditions
- Depression
- Being tested
- intermittent Theta burst stimulation
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent Theta burst stimulationDevice
Stimulation of the left dorsolateral prefrontal Cortex with a specific repetitive transcranial magnetic Stimulation protocol (intermittent Theta burst Stimulation) according to Blumberger et al., 2018, Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692.
| Study group | Role | What they receive |
|---|---|---|
| navigated | Experimental | Positioning of the coil according to neuronavigation (Mylius et al., 2013, Definition of DLPFC and M1 according to anatomical landmarks for navigated brain stimulation: Inter-rater reliability, accuracy, and influence of gender and Age, NeuroImage 78, 224-232). Receives: Device: intermittent Theta burst stimulation |
| F3 | Active comparator | Positioning of the coil according to EEG (electroencephalography) electrode Position F3 (marking this Position on a head cap). Receives: Device: intermittent Theta burst stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
HAMD
Hamilton Depression Rating Scale
Measured: 4 weeks
Secondary outcomes (5)
HAMD
Hamilton Depression Rating Scale
Measured: 16 weeks
MDI
Major Depression Inventory
Measured: 16 weeks
PHQ-9
9-question depression scale from the Patient Health Questionnaire
Measured: 16 weeks
WHOQOL-BREF
WHO Quality of life scale (abbreviated Version)
Measured: 16 weeks
CGI
Clincial Global Impression change
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2019
- Study start1 Jun 2019
- Primary completion27 May 2020
- Study completion27 May 2020
Why it stopped: Interim analysis indicated no statistical difference between treatment arms.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 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
- NCT03953521
- Sponsor's protocol ID
- 18-1231-101
- Acronym
- neuronaviTBS
- Status last verified
- May 2020
- First submitted
- 14 May 2019
- Last updated
- 1 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hebel T, Gollnitz A, Schoisswohl S, Weber FC, Abdelnaim M, Wetter TC, Rupprecht R, Langguth B, Schecklmann M. A direct comparison of neuronavigated and non-neuronavigated intermittent theta burst stimulation in the treatment of depression. Brain Stimul. 2021 Mar-Apr;14(2):335-343. doi: 10.1016/j.brs.2021.01.013. Epub 2021 Jan 22.
PubMed 33493624
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuronavigated Theta Burst Stimulation in Depression
- ClinicalTrials.gov ID
- NCT03953521
- Acronym / sponsor ID
- neuronaviTBS / 18-1231-101
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Interim analysis indicated no statistical difference between treatment arms.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of RegensburgUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 27 May 2020 (actual)
- Study completion
- 27 May 2020 (actual)
- First posted
- 16 May 2019 (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.
In this randomized controlled trial we will treat 80 patients with depression with intermittent theta burst stimulation in two parallel arms. Both arms are active interventions differing with respect to positioning of the treatment coil - one arm with neuronavigation and one arm with targeting according to EEG Position representing the left dorsolateral prefrontal cortex. Randomisation will be balanced for in- and out-patients and for the treatment arms.
Detailed description
Intermittent Theta burst Stimulation (iTBS) is a specific type of repetitive transcranial magnetic Stimulation (rTMS). rTMS of the left prefrontal cortex was shown to be effective in the treatment of Depression. Recent studies showed that iTBS probably is as effective as rTMS.
One possibility to increase to efficacy of rTMS/iTBS is to use neuronavigation. With neuronavigation the coil Position can be targeted with an accuracy in the range of millimeters. Furthermore the Stimulation Position can be ensured during one single session and over the course of the daily Treatments.
The aim of the present study is to investigate the benefit of neuronavigation in the Treatment of Depression with iTBS by using two arms one with targeting the Stimulation site with neuronavigation and one by using the EEG Position F3 as target by using head caps for marking the position.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| navigated | Experimental | Device: intermittent Theta burst stimulationPositioning of the coil according to neuronavigation (Mylius et al., 2013, Definition of DLPFC and M1 according to anatomical landmarks for navigated brain stimulation: Inter-rater reliability, accuracy, and influence of gender and Age, NeuroImage 78, 224-232). |
| F3 | Active comparator | Device: intermittent Theta burst stimulationPositioning of the coil according to EEG (electroencephalography) electrode Position F3 (marking this Position on a head cap). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- unipolar or bipoloar depressive Episode according to ICD-10
- at least moderate Depression according to Hamilton Depression Rating Scale or ICD-10
- if applicable stable medication with psychoactive compounds for out-patients
- if applicable no or stable Treatment for Depression during the course of the Trial
- residence in Germany and mother tongue German
Key exclusion criteria (7 listed)
- Meeting the contraindications for transcranial magnetic Stimulation or magnetic resonance Imaging (electic devices or metal implants in the Body, e.g. cardiac pace maker, Insulin ppump)
- neurological disorders (e.g. cerebrovascular Events, neurodegenerative disorder, epilepsy, brain malformation, severe head Trauma)
- addictive disorder with consumption in the last two years
- regular intake of benzodiazepines
- participation in another study parallel to the Trial
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 |
|---|---|---|
| intermittent Theta burst stimulationStimulation of the left dorsolateral prefrontal Cortex with a specific repetitive transcranial magnetic Stimulation protocol (intermittent Theta burst Stimulation) according to Blumberger et al., 2018, Effectiveness of theta burst versus high-frequency repetitive transcranial magnetic stimulation in patients with depression (THREE-D): a randomised non-inferiority trial. Lancet. 2018 Apr 28;391(10131):1683-1692. | Device | F3, navigated |
Primary outcome
HAMD
Time frame: 4 weeks
Hamilton Depression Rating Scale
5 secondary outcomes
HAMD
Time frame: 16 weeks
MDI
Time frame: 16 weeks
PHQ-9
Time frame: 16 weeks
WHOQOL-BREF
Time frame: 16 weeks
CGI
Time frame: 16 weeks
Results and safety
The study was stopped early (reason given: Interim analysis indicated no statistical difference between treatment arms.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2020.
- Derived from this study: PubMed 33493624Hebel T, Gollnitz A, Schoisswohl S, Weber FC, Abdelnaim M, Wetter TC, Rupprecht R, Langguth B, Schecklmann M. A direct comparison of neuronavigated and non-neuronavigated intermittent theta burst stimulation in the treatment of depression. Brain Stimul. 2021 Mar-Apr;14(2):335-343. doi: 10.1016/j.brs.2021.01.013. Epub 2021 Jan 22.
Related trials for Depression
Not yet recruiting
Examining the Effectiveness of a Brief Therapeutic Intervention for Reducing Self-Harm Among Adolescents
Self Injurious Behavior, Self Injurious Behavior Without Suicidal Intent
RecruitingPhase 3
A Study of Brenipatide (LY3537031) in Adult Participants With Major Depressive Disorder
Depressive Disorder, Major
Recruiting
EEG-Guided Transcranial Magnetic Stimulation for Adults With Depression
Major Depressive Disorder (MDD), Treatment Resistant Depression
Recruiting
Aquatic Exercise in Patients With Knee Osteoarthritis
Central Sensitization, Knee Osteoarthristis
Recruiting
Defining Neurobiological Links Between Substance Use and Mental Illness
Major Depressive Disorder, Substance Use Disorder
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 intermittent Theta burst 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 6 inclusion and 7 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: stopped early, as of the sponsor's last update on 1 Jun 2020. 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 was stopped early (reason given: Interim analysis indicated no statistical difference between treatment arms.). Results are not available in the source record.
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?
HAMD (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03953521, which also lists 1 linked publication.
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 1 Jun 2020.