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Neuronavigated TBS in Depression (neuronaviTBS)

Primary Purpose

Depression

Status
Terminated
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
intermittent Theta burst stimulation
Sponsored by
University of Regensburg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Psychiatry and Psychotherapy, University of Regensburg

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

navigated

F3

Arm Description

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).

Positioning of the coil according to EEG (electroencephalography) electrode Position F3 (marking this Position on a head cap).

Outcomes

Primary Outcome Measures

HAMD
Hamilton Depression Rating Scale

Secondary Outcome Measures

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

Full Information

First Posted
May 14, 2019
Last Updated
May 28, 2020
Sponsor
University of Regensburg
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1. Study Identification

Unique Protocol Identification Number
NCT03953521
Brief Title
Neuronavigated TBS in Depression
Acronym
neuronaviTBS
Official Title
Neuronavigated Theta Burst Stimulation in Depression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis indicated no statistical difference between treatment arms.
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
May 27, 2020 (Actual)
Study Completion Date
May 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Regensburg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
navigated
Arm Type
Experimental
Arm Description
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).
Arm Title
F3
Arm Type
Active Comparator
Arm Description
Positioning of the coil according to EEG (electroencephalography) electrode Position F3 (marking this Position on a head cap).
Intervention Type
Device
Intervention Name(s)
intermittent Theta burst stimulation
Intervention Description
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 Measure Information:
Title
HAMD
Description
Hamilton Depression Rating Scale
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
HAMD
Description
Hamilton Depression Rating Scale
Time Frame
16 weeks
Title
MDI
Description
Major Depression Inventory
Time Frame
16 weeks
Title
PHQ-9
Description
9-question depression scale from the Patient Health Questionnaire
Time Frame
16 weeks
Title
WHOQOL-BREF
Description
WHO Quality of life scale (abbreviated Version)
Time Frame
16 weeks
Title
CGI
Description
Clincial Global Impression change
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Berthold Langguth, PhD
Organizational Affiliation
University of Regensburg
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychiatry and Psychotherapy, University of Regensburg
City
Regensburg
ZIP/Postal Code
93055
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
33493624
Citation
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.
Results Reference
derived

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Neuronavigated TBS in Depression

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