Deep Brain Stimulation for Schizophrenia
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, since it involves deep brain stimulation for treatment-resistant schizophrenia, it's possible that you may need to continue your current antipsychotic medications.
What data supports the effectiveness of the treatment Deep Brain Stimulation for schizophrenia?
Deep Brain Stimulation (DBS) has shown promise in treating schizophrenia, especially in patients who do not respond to other treatments. In a small trial, some patients experienced improvement in symptoms, and changes in brain activity were linked to these improvements, suggesting DBS may help by altering brain circuits involved in schizophrenia.12345
Is Deep Brain Stimulation generally safe for humans?
Deep Brain Stimulation (DBS) has been used safely for various conditions, but complications like infections and device-related issues can occur. In early trials for schizophrenia, one out of eight participants experienced a hemorrhage and infection, indicating some risk, though more data is needed to fully understand safety in this specific group.24567
How is deep brain stimulation different from other treatments for schizophrenia?
Deep brain stimulation (DBS) is unique because it involves surgically implanting electrodes in specific brain areas to modulate brain activity, unlike traditional treatments like antipsychotic medications or electroconvulsive therapy. It is particularly considered for patients with treatment-resistant schizophrenia who do not respond to standard therapies.12356
What is the purpose of this trial?
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.
Research Team
Nicola Cascella
Principal Investigator
Johns Hopkins University
Eligibility Criteria
This trial is for adults at least 22 years old with severe, treatment-resistant schizophrenia who have not responded to multiple antipsychotic medications. Participants must be able to walk, understand English, consent to the study, and use birth control if necessary. They can't join if they've had recent major surgery, drug abuse issues within the last six months, or any medical conditions that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Deep brain stimulation of the substantia nigra pars reticulata for treatment-resistant schizophrenia
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Deep Brain Stimulation
Deep Brain Stimulation is already approved in United States, European Union, Canada for the following indications:
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
- Stroke-related motor deficits (under investigation)
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
- Essential tremor
- Parkinson's disease
- Dystonia
- Obsessive-compulsive disorder
- Epilepsy
- Chronic pain
Find a Clinic Near You
Who Is Running the Clinical Trial?
Johns Hopkins University
Lead Sponsor
National Institute of Mental Health (NIMH)
Collaborator