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Neuronavigated TBS in Depression (neuronaviTBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03953521
Recruitment Status : Terminated (Interim analysis indicated no statistical difference between treatment arms.)
First Posted : May 16, 2019
Last Update Posted : June 1, 2020
Sponsor:
Information provided by (Responsible Party):
Berthold Langguth, MD, Ph.D., University of Regensburg

Tracking Information
First Submitted Date  ICMJE May 14, 2019
First Posted Date  ICMJE May 16, 2019
Last Update Posted Date June 1, 2020
Actual Study Start Date  ICMJE June 1, 2019
Actual Primary Completion Date May 27, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
HAMD [ Time Frame: 4 weeks ]
Hamilton Depression Rating Scale
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2019)
  • HAMD [ Time Frame: 16 weeks ]
    Hamilton Depression Rating Scale
  • MDI [ Time Frame: 16 weeks ]
    Major Depression Inventory
  • PHQ-9 [ Time Frame: 16 weeks ]
    9-question depression scale from the Patient Health Questionnaire
  • WHOQOL-BREF [ Time Frame: 16 weeks ]
    WHO Quality of life scale (abbreviated Version)
  • CGI [ Time Frame: 16 weeks ]
    Clincial Global Impression change
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Neuronavigated TBS in Depression
Official Title  ICMJE Neuronavigated Theta Burst Stimulation in Depression
Brief 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.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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).
    Intervention: 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).
    Intervention: Device: intermittent Theta burst stimulation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 28, 2020)
37
Original Estimated Enrollment  ICMJE
 (submitted: May 14, 2019)
80
Actual Study Completion Date  ICMJE May 27, 2020
Actual Primary Completion Date May 27, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03953521
Other Study ID Numbers  ICMJE 18-1231-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Berthold Langguth, MD, Ph.D., University of Regensburg
Study Sponsor  ICMJE University of Regensburg
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Berthold Langguth, PhD University of Regensburg
PRS Account University of Regensburg
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP