Neuronavigated TBS in Depression

Depression Clinical Trial

— neuronaviTBS  

Official title:

Neuronavigated Theta Burst Stimulation in Depression

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03953521
• Other study ID #: 18-1231-101
• Status: Terminated
• Phase: N/A
• Start date: June 1, 2019
• Est. completion date: May 27, 2020

Study information

• Verified date: May 2020
• Source: University of Regensburg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 37
• Est. completion date: May 27, 2020
• Est. primary completion date: May 27, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
Germany	Department of Psychiatry and Psychotherapy, University of Regensburg	Regensburg

Sponsors (1)

Lead Sponsor	Collaborator
University of Regensburg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HAMD	Hamilton Depression Rating Scale	4 weeks
Secondary	HAMD	Hamilton Depression Rating Scale	16 weeks
Secondary	MDI	Major Depression Inventory	16 weeks
Secondary	PHQ-9	9-question depression scale from the Patient Health Questionnaire	16 weeks
Secondary	WHOQOL-BREF	WHO Quality of life scale (abbreviated Version)	16 weeks
Secondary	CGI	Clincial Global Impression change	16 weeks