Ignite Creation Date:
2024-05-05 @ 11:37 PM
Last Modification Date:
2024-10-26 @ 10:36 AM
Study NCT ID:
NCT01372722
Status:
WITHDRAWN
Last Update Posted:
2018-08-07
First Post:
2011-05-06
Brief Title:
Deep Brain Stimulation DBS for Treatment Resistant Bipolar Disorder
Sponsor:
University Hospital Bonn
Organization:
University Hospital Bonn
Study Overview
Official Title:
Phase I Study of Bilateral DBS to the Nucleus Accumbens NAcc-DBS for Treatment Resistant Bipolar Disorder
Status:
WITHDRAWN
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Other stimulation target slMFB more efficacious unethical to continue with Nucleus Accumbens
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DBS-BIPO
Brief 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None