6 Participants Needed

Deep Brain Stimulation for Schizophrenia

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Johns Hopkins University
Must be taking: Antipsychotics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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

NC

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

I have been diagnosed with schizophrenia or schizoaffective disorder.
I can walk on my own.
A psychiatrist confirmed I can make my own medical decisions.
See 5 more

Exclusion Criteria

Subject has a medical illness/condition, co-morbid psychiatric illness, and/or abnormal diagnostic finding that would interfere with the completion of the study, confound the results of the study, or pose risk to the patient
Subject has participated in another investigational drug trial or therapeutic trial within 30 days of Baseline Visit 1
Subject has a diagnosis of mental retardation
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Deep brain stimulation of the substantia nigra pars reticulata for treatment-resistant schizophrenia

1 year
Frequent monitoring and clinical assessment with psychiatric scales

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Deep Brain Stimulation
Trial Overview The trial tests Deep Brain Stimulation (DBS) using Medtronic's Percept with SensSight System targeting a brain area called substantia nigra pars reticulata (SNr). It aims to help those whose schizophrenia doesn't improve with medication by potentially altering neural circuits involved in the disorder.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Deep Brain Stimulation ImplantExperimental Treatment1 Intervention
Unblinded treatment arm, deep brain stimulation of the substantia nigra pars reticulata for treatment resistant schizophrenia.

Deep Brain Stimulation is already approved in United States, European Union, Canada for the following indications:

πŸ‡ΊπŸ‡Έ
Approved in United States as Deep Brain Stimulation for:
  • Essential tremor
  • Parkinson's disease
  • Dystonia
  • Obsessive-compulsive disorder
  • Epilepsy
  • Chronic pain
  • Stroke-related motor deficits (under investigation)
πŸ‡ͺπŸ‡Ί
Approved in European Union as Deep Brain Stimulation for:
  • Essential tremor
  • Parkinson's disease
  • Dystonia
  • Obsessive-compulsive disorder
  • Epilepsy
  • Chronic pain
πŸ‡¨πŸ‡¦
Approved in Canada as Deep Brain Stimulation for:
  • 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

Trials
2,366
Recruited
15,160,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials
3,007
Recruited
2,852,000+

Findings from Research

Deep brain stimulation (DBS) has shown promise in treating treatment-resistant schizophrenia, with four out of seven patients meeting symptomatic response criteria after stimulation in either the subgenual anterior cingulate cortex or the nucleus accumbens.
DBS was associated with significant changes in glucose metabolism in various brain regions, suggesting that it may improve symptoms by modulating activity in the cortico-basal-thalamic-cortical circuit.
Brain metabolic changes in patients with treatment resistant schizophrenia treated with deep brain stimulation: A series of cases.RoldΓ‘n, A., Portella, MJ., Sampedro, F., et al.[2021]
Deep brain stimulation (DBS) is being explored as a potential treatment for schizophrenia (SZ), a condition that currently has significant unmet needs due to issues like relapse and ineffective treatments for negative and cognitive symptoms.
Research suggests that SZ may be a circuit disorder, and DBS could help by modulating striatal dysregulation, with ongoing clinical trials assessing its efficacy and ethical considerations for patients with severe symptoms.
Approaches to neuromodulation for schizophrenia.Gault, JM., Davis, R., Cascella, NG., et al.[2022]
Deep brain stimulation (DBS) targeting the nucleus accumbens (NAcc) and subgenual anterior cingulate cortex (subgenual ACC) shows potential therapeutic effects in treatment-resistant schizophrenia, with 58% improvement in PANSS scores for NAcc and 68% for subgenual ACC among patients who met improvement criteria.
While physical side effects were rare, two patients experienced persistent psychiatric adverse effects, highlighting the need for larger trials to assess the safety and efficacy of DBS in this population.
Deep brain stimulation in treatment resistant schizophrenia: A pilot randomized cross-over clinical trial.Corripio, I., RoldΓ‘n, A., SarrΓ³, S., et al.[2021]

References

Brain metabolic changes in patients with treatment resistant schizophrenia treated with deep brain stimulation: A series of cases. [2021]
Approaches to neuromodulation for schizophrenia. [2022]
Deep brain stimulation in treatment resistant schizophrenia: A pilot randomized cross-over clinical trial. [2021]
Postsurgical morbidity and mortality favorably informs deep brain stimulation for new indications including schizophrenia and schizoaffective disorder. [2023]
Deep brain stimulation and digital monitoring for patients with treatment-resistant schizophrenia and bipolar disorder: A case series. [2023]
Habenula deep brain stimulation for intractable schizophrenia: a pilot study. [2021]
Systematic review of hardware-related complications of Deep Brain Stimulation: Do new indications pose an increased risk? [2022]
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