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Neuronavigated TBS in Depression (neuronaviTBS)

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ClinicalTrials.gov Identifier: NCT03953521
Recruitment Status : Recruiting
First Posted : May 16, 2019
Last Update Posted : May 22, 2019
Sponsor:
Information provided by (Responsible Party):
Berthold Langguth, MD, Ph.D., University of Regensburg

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.

Condition or disease Intervention/treatment Phase
Depression Device: intermittent Theta burst stimulation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Neuronavigated Theta Burst Stimulation in Depression
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : May 31, 2021

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. HAMD [ Time Frame: 4 weeks ]
    Hamilton Depression Rating Scale


Secondary Outcome Measures :
  1. HAMD [ Time Frame: 16 weeks ]
    Hamilton Depression Rating Scale

  2. MDI [ Time Frame: 16 weeks ]
    Major Depression Inventory

  3. PHQ-9 [ Time Frame: 16 weeks ]
    9-question depression scale from the Patient Health Questionnaire

  4. WHOQOL-BREF [ Time Frame: 16 weeks ]
    WHO Quality of life scale (abbreviated Version)

  5. CGI [ Time Frame: 16 weeks ]
    Clincial Global Impression change



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953521


Contacts
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Contact: Martin Schecklmann, PhD +49-941-941-2054 martin.schecklmann@medbo.de

Locations
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Germany
Department of Psychiatry and Psychotherapy, University of Regensburg Recruiting
Regensburg, Germany, 93055
Contact: Berthold Langguth    +49-941-941-2099    berthold.langguth@medbo.de   
Sponsors and Collaborators
University of Regensburg
Investigators
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Principal Investigator: Berthold Langguth, PhD University of Regensburg

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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
ClinicalTrials.gov Identifier: NCT03953521     History of Changes
Other Study ID Numbers: 18-1231-101
First Posted: May 16, 2019    Key Record Dates
Last Update Posted: May 22, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders