Neuronavigated TBS in Depression (neuronaviTBS)

May 28, 2020 updated by: Berthold Langguth, MD, Ph.D., University of Regensburg

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

37

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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.
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
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 is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HAMD
Time Frame: 4 weeks
Hamilton Depression Rating Scale
4 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Regensburg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2019

Primary Completion (ACTUAL)

May 27, 2020

Study Completion (ACTUAL)

May 27, 2020

Study Registration Dates

First Submitted

May 14, 2019

First Submitted That Met QC Criteria

May 14, 2019

First Posted (ACTUAL)

May 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

June 1, 2020

Last Update Submitted That Met QC Criteria

May 28, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 18-1231-101

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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