Neuronavigated TBS in Depression

NCT ID: NCT03953521

Last Updated: 2020-06-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-01
• Study Completion Date: 2020-05-27

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

intermittent Theta burst stimulation

Intervention Type: DEVICE

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.

F3

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

Group Type: ACTIVE_COMPARATOR

intermittent Theta burst stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Regensburg

OTHER

Sponsor Role: lead

Responsible Party

Berthold Langguth, MD, Ph.D.

Head of Center II and out-patient clinic of the Department of Psychiatry and Psychotherapy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Berthold Langguth, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Regensburg

Locations

Department of Psychiatry and Psychotherapy, University of Regensburg

Regensburg, , Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 33493624 (View on PubMed)

Other Identifiers

18-1231-101

Identifier Type: -

Identifier Source: org_study_id