Deep Brain Stimulation of the Superolateral Branch of the Medial Forebrain Bundle (slMFB) for the Treatment of Refractory Major Depression
NCT01778790 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 16
Last updated 2018-08-07
Summary
The investigators will investigate in a sham controlled staggered onset design antidepressant effects and safety of deep brain stimulation (DBS) to the superolateral branch of the main medial forebrain bundle (slMFB).
Conditions
Interventions
- DEVICE
-
Deep Brain Stimulation with Activa PC Multi-program Neurostimulator
Device: DBS 130 Hertz (Hz) frequency, 90us pulsewidth, 4 Volt (V) currency Amplitude Device: DBS - No Stimulation (Sham) 130 Hertz (Hz)frequency, 90us pulsewidth, 0 Volt (V) currency Amplitude
Sponsors & Collaborators
-
University Hospital, Bonn
lead OTHER
Principal Investigators
-
Thomas E. Schlaepfer, MD · University Hospital, Bonn
-
Volker Coenen, MD · University Hospital Freiburg
Study Design
- Purpose
- TREATMENT
- Masking
- DOUBLE
Eligibility
- Min Age
- 20 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2013-07-31
- Primary Completion
- 2016-02-29
- Completion
- 2018-01-31
Countries
- Germany
Study Locations
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