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Deep Brain Stimulation in Treatment Refractory Depression

NCT01921543 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2015-07-16

No results posted yet for this study

Summary

The main aim of this trial was to investigate whether patients suffering from treatment refractory- Major Depressive Disorder (MDD) can benefit from DBS (Deep Brain Stimulation) in the brain areas known as inferior thalamic peduncle (ITP) and/or Capsula Interna/Bed nucleus of the stria terminalis (CI/BNST)

Conditions

Interventions

DEVICE

ITP Stimulation

Model 7428 Kinetra® Neurostimulator Model 3887 DBSTM Pisces Quad Compact Model 3389 DBSTM Brain Lead Model 3387 DBSTM Brain Lead Model 7482-51 Extension Model 7482-66 Extension Model 7482-95 Extension Model 7436 AccessTM Therapy Controller Model 3628 Dual Screener TM Model 8840 N'Vision

DEVICE

CI/BNST stimulation

Model 7428 Kinetra® Neurostimulator Model 3887 DBSTM Pisces Quad Compact Model 3389 DBSTM Brain Lead Model 3387 DBSTM Brain Lead Model 7482-51 Extension Model 7482-66 Extension Model 7482-95 Extension Model 7436 AccessTM Therapy Controller Model 3628 Dual Screener TM Model 8840 N'Vision

DEVICE

No stimulation

Sponsors & Collaborators

  • Medtronic

    collaborator INDUSTRY

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2013-10-31
Completion
2013-10-31

Countries

  • Belgium

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01921543 on ClinicalTrials.gov