Trials / Withdrawn
WithdrawnNCT01372722
Deep Brain Stimulation (DBS) for Treatment Resistant Bipolar Disorder
Phase I Study of Bilateral DBS to the Nucleus Accumbens (NAcc-DBS) for Treatment Resistant Bipolar Disorder
- Status
- Withdrawn
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- University Hospital, Bonn · Academic / Other
- Sex
- All
- Age
- 20 Years – 70 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| DEVICE | DBS Activa PC systems Medtronic | 130Hz, 90us pulsewidth, 4V Amplitude |
| DEVICE | DBS, Activa PC systems Medtronic | 30Hz, 90us pulsewidth, 4V Amplitude |
Timeline
- Start date
- 2010-05-01
- Primary completion
- 2012-05-01
- Completion
- 2012-05-01
- First posted
- 2011-06-14
- Last updated
- 2018-08-07
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT01372722. Inclusion in this directory is not an endorsement.