TerminatedNCT03953521neuronaviTBSUpdated Jun 1, 2020

Neuronavigated TBS in Depression

An interventional study of intermittent Theta burst stimulation in Depression, sponsored by University of Regensburg. Terminated at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2020-06-01.

Sponsored by University of Regensburg · Not applicable, Interventional, and Treatment

Why this study was terminated

Interim analysis indicated no statistical difference between treatment arms.

Phase: Not applicable
Study type: Interventional
Enrollment: 37
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Study 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 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 studied

Depression

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Depression 8,245

In context

Depression

8,245 studies on the registry are indexed under Depression; 1,641 are open to participants now.

This study's enrollment of 37 is below the median of 84 across 6,869 interventional studies indexed under Depression.

Browse Depression studies →

Lead sponsor

University of Regensburg is the lead sponsor of 71 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 75 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 37 participants (actual)

Study arms

Experimental
navigated
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).
Device: intermittent Theta burst stimulation
Active comparator
F3
Positioning of the coil according to EEG (electroencephalography) electrode Position F3 (marking this Position on a head cap).
Device: intermittent Theta burst stimulation

Interventions

Deviceintermittent Theta burst stimulation
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.

What researchers measure

Primary outcomes

HAMD
Hamilton Depression Rating Scale
Time frame: 4 weeks

Secondary outcomes

HAMD
Hamilton Depression Rating Scale
Time frame: 16 weeks
MDI
Major Depression Inventory
Time frame: 16 weeks
PHQ-9
9-question depression scale from the Patient Health Questionnaire
Time frame: 16 weeks
WHOQOL-BREF
WHO Quality of life scale (abbreviated Version)
Time frame: 16 weeks
CGI
Clincial Global Impression change
Time frame: 16 weeks

Study locations

1 site

Department of Psychiatry and Psychotherapy, University of Regensburg
Regensburg, 93055, Germany

References and documents

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 ↗

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Ran from Jun 2019 to primary completion in May 2020, 11 months.

How these figures are worked out, and which studies are left out of them.

Registered: May 14, 2019
First posted: May 16, 2019
StartActual: Jun 1, 2019
Primary completionActual: May 27, 2020
CompletionActual: May 27, 2020
Last update: Jun 1, 2020

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Jun 1, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03953521
Lead sponsor: University of Regensburg
Responsible party: Berthold Langguth, MD, Ph.D. (Head of Center II and out-patient clinic of the Department of Psychiatry and Psychotherapy, University of Regensburg) — Principal investigator
First posted: May 16, 2019
Start date: Jun 1, 2019
Primary completion: May 27, 2020
Completion: May 27, 2020
Last update: Jun 1, 2020

Study contacts

Berthold Langguth, PhD

principal investigator · University of Regensburg

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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