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Deep Brain Stimulation (DBS) for Treatment Resistant Bipolar Disorder

NCT01372722 · Status: WITHDRAWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL

Last updated 2018-08-07

No results posted yet for this study

Summary

Hypothesis to be tested:

Bilateral Deep Brain Stimulation to the Nucleus Accumbens is associated with clinically and statistically significant improvement in patients with treatment resistant bipolar disorder.

Overall Objective:

The aim in this interdisciplinary, psychiatric-neurosurgical project is to evaluate safety and efficacy of bilateral Deep Brain Stimulation to the Nucleus Accumbens (NAcc) using the Medtronic Activa RC Neurostimulator in patients with treatment resistant Bipolar Disorder.

Conditions

Interventions

DEVICE

DBS Activa PC systems Medtronic

130Hz, 90us pulsewidth, 4V Amplitude

DEVICE

DBS, Activa PC systems Medtronic

30Hz, 90us pulsewidth, 4V Amplitude

Sponsors & Collaborators

  • University Hospital, Bonn

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-05-31
Primary Completion
2012-05-31
Completion
2012-05-31

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

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 NCT01372722 on ClinicalTrials.gov