Deep Brain Stimulation in Treatment Resistant Schizophrenia
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|ClinicalTrials.gov Identifier: NCT02361554|
Recruitment Status : Recruiting
First Posted : February 11, 2015
Last Update Posted : September 6, 2018
The purpose of this pilot study is to investigate the use of deep brain stimulation (DBS) of the substantia nigra pars reticulata (SNr) in subjects with treatment-resistant schizophrenia. There is a subset of patients with schizophrenia who continue to have persistent psychotic symptoms (auditory hallucinations and delusions) despite multiple adequate medication trials with antipsychotic medications including clozapine. There are currently no available treatments for such patients who generally have poor function and are chronically disabled, unable to work, live independently or have meaningful social relationships. Neuroimaging studies in patients with schizophrenia have revealed information about pathological neural circuits that could be suitable targets using deep brain stimulation. Although not yet tested in patients with schizophrenia, DBS is in early phase clinical trials in other psychiatric disorders.
This pilot study will investigate the use of DBS in treatment-resistant schizophrenia subjects who have exhausted all other therapeutic alternatives but continue to have persistent disabling psychotic symptoms. Of note, DBS is not FDA approved for use in patients with schizophrenia. The method will be similar to that used in subthalamic nucleus stimulation in patients with Parkinson's Disease. However, the electrode will be advanced slightly inferior into the SNr, a major outflow nucleus of the basal ganglia, with the intention of causing local inhibition of SNr outflow resulting in disinhibition of the mediodorsal nucleus (MDN) of the thalamus. Hypofunction of the MDN has been implicated in the pathophysiology of schizophrenia in post-mortem as well as multiple structural and functional imaging studies. Evidence suggests that dysfunction of the MD is implicated in both positive and cognitive symptoms (such as working memory impairment) in schizophrenia. Frequent monitoring and clinical assessment with psychiatric scales will be used to monitor treatment response.
|Condition or disease||Intervention/treatment||Phase|
|Treatment-resistant Schizophrenia||Device: Medtronic Activa Deep Brain Stimulation System||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Deep Brain Stimulation in Treatment Resistant Schizophrenia|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2019|
Experimental: Deep Brain Stimulation Implant
Unblinded treatment arm, deep brain stimulation of the substantia nigra pars reticulata for treatment resistant schizophrenia.
Device: Medtronic Activa Deep Brain Stimulation System
- Change from baseline in the Scales for the Assessment of Negative Symptoms (SANS) [ Time Frame: 1 year after neurostimulator implantation ]We will assess deep brain stimulation effects on negative symptoms aspects of schizophrenia.
- Change from baseline in the Brief Psychiatric Rating Scale [ Time Frame: 1 year after neurostimulator implantation ]We will assess deep brain stimulation effects on the positive and psychosis features of schizophrenia.
- Incidence of adverse device effects (ADEs). [ Time Frame: 1 year after neurostimulator implantation ]We will assess the incidence of adverse device effects as defined by the Code of Federal Regulations (21 CFR 812.3)
- Change from baseline in the Young Mania scale (YMS) [ Time Frame: 1 year after neurostimulator implantation ]We will assess deep brain stimulation effects on mania as assessed by the YMS.
- Change from baseline in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) cognitive test battery. [ Time Frame: 1 year after neurostimulator implantation ]We will assess deep brain stimulation effects on cognition as assessed by the MATRICS cognitive test battery.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02361554
|United States, Maryland|
|The Johns Hopkins Hospital||Recruiting|
|Baltimore, Maryland, United States, 21287|
|Contact: William S Anderson, PhD, MD 443-287-1609|