Deep Brain Stimulation (DBS) for Treatment Resistant Bipolar Disorder (DBS-BIPO)
Recruitment status was: Recruiting
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.
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.
|Bipolar Disorder||Device: DBS Activa PC systems Medtronic Device: DBS, Activa PC systems Medtronic||Phase 2 Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Phase I Study of Bilateral DBS to the Nucleus Accumbens (NAcc-DBS) for Treatment Resistant Bipolar Disorder|
- Depression Severity rated with Montgomery Asberg Depression Scale (MADRS) [ Time Frame: 12 month after DBS stimulation onset ]The Montgomery-Åsberg Depression Rating Scale (abbreviated MADRS) is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders. It was designed in 1979 by British and Swedish researchers as an adjunct to the Hamilton Rating Scale for Depression (HAMD) which would be more sensitive to the changes brought on by antidepressants and other forms of treatment than the Hamilton Scale is.
- Young Mania Rating Scale (YMRS) [ Time Frame: 12 month after DBS stimulation onset ]One of the most frequently used rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition over the previous 48 hours. This scale will be used to assess the development of manic symptoms over time, mainly in order to assess treatment emergent manic symptoms.
- Depression Severity rated with Hamilton Depression Rating Scale (HDRS24) [ Time Frame: 12 month after DBS stimulation onset ]The Hamilton Rating Scale for Depression (HRSD), also known as the Hamilton Depression Rating Scale (HDRS) or abbreviated to HAM-D, is a multiple choice questionnaire that clinicians may use to rate the severity of a patient's major depression. The questionnaire rates the severity of symptoms observed in depression such as low mood, insomnia, agitation, anxiety and weight loss. The questionnaire is presently one of the most commonly used scales for rating depression in medical research.
- Adverse Event Schedule [ Time Frame: 12 month after DBS stimulation onset ]Adverse events induced by the Stimulation will be recorded during the study using a structured questionnaire. 12 months after stimulation onset results will be compiled and rated as being due to DBS or not.
- Comprehensive neuropsychological test battery [ Time Frame: 12 month after DBS stimulation onset ]
- General cognitive functions (Mini-Mental State Examination)
- Attention (d2 attention-burden test)
- Learning and memory tests covering verbal and visual spatial learning, memory and working memory (Verbal Learning and Memory Test, Rey Visual Design Learning Test,Wechsler Memory Scale)
- language (HAWIE lexis tests, HAWIE finding similarities)
- Executive functions (Trail Making Tests, Five-Point Test, and the Stroop test)
- Visual perception (Hooper Visual Organization Test)
|Study Start Date:||May 2010|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
|Experimental: Sham then Stimulation||
Device: DBS Activa PC systems Medtronic
130Hz, 90us pulsewidth, 4V Amplitude
|Experimental: Stimulation then Sham||
Device: DBS, Activa PC systems Medtronic
30Hz, 90us pulsewidth, 4V Amplitude
Please refer to this study by its ClinicalTrials.gov identifier: NCT01372722
|Contact: Bettina Bewernick, BA||Bettina.Bewernick@ukb.uni-bonn.de|
|Contact: Sarah Kayser, MDemail@example.com|
|Department of Psychiatry and Psychotherapy - University Hospital||Recruiting|
|Bonn, Germany, 53105|
|Contact: Sarah Kayser, MD +49 228 287 15715 firstname.lastname@example.org|