Deep Brain Stimulation for Schizophrenia

NC
Overseen ByNicola Cascella
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)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called deep brain stimulation (DBS) for individuals with schizophrenia who haven't found relief from other treatments. DBS involves implanting a device that sends electrical signals to specific brain areas, potentially easing persistent symptoms like hearing voices or having strong false beliefs. The researchers aim to assist those who continue to struggle despite trying several medications, including clozapine, often considered the last resort. This trial might suit someone who has had schizophrenia for at least a year with ongoing severe symptoms despite trying various medications. As an unphased trial, this study offers a unique opportunity for patients to explore innovative treatment options that might provide relief when other treatments have failed.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the study involves treatment-resistant schizophrenia, it might be possible that you continue with your current medications unless otherwise directed by the study team.

What prior data suggests that this deep brain stimulation method is safe for treatment-resistant schizophrenia?

Research has shown that deep brain stimulation (DBS) holds promise for safely treating conditions like epilepsy, where patients have tolerated it well. Although DBS is not yet approved for schizophrenia, early results suggest it could help without major safety issues. In a small study of seven patients with treatment-resistant schizophrenia, four experienced symptom improvements, indicating the treatment was generally well tolerated.

The trial used the Medtronic Percept with SensSight System, which is considered safe based on data from other applications, provided specific conditions are met. Failure to follow these conditions could lead to risks like tissue damage from heating.

While the treatment appears promising, it's important to remember that research is ongoing, and safety data specific to schizophrenia is still being gathered. Always discuss potential risks and benefits with the trial team.12345

Why are researchers excited about this trial?

Deep Brain Stimulation (DBS) for schizophrenia is unique because it targets the brain's substantia nigra pars reticulata, a new approach compared to standard treatments like antipsychotic medications, which typically adjust neurotransmitter levels. Researchers are excited about this treatment because DBS offers a non-drug approach that could potentially help people with treatment-resistant schizophrenia, where other options have failed. Unlike medications that take time to adjust and may have side effects, DBS is a direct intervention that could provide more immediate and sustained symptom relief.

What evidence suggests that deep brain stimulation is effective for treatment-resistant schizophrenia?

Research has shown that deep brain stimulation (DBS) might help some people with schizophrenia that doesn't improve with regular treatments. One study found that almost half of the patients who tried DBS experienced significant improvement. In this trial, participants will receive DBS using the Medtronic Percept with SensSight system, which tracks brain signals and allows doctors to adjust the treatment in real-time. This treatment targets a specific part of the brain to alleviate symptoms like hearing voices or having false beliefs. Early trials are promising, but further research is needed to fully understand its effectiveness.12345

Who Is on the Research Team?

NC

Nicola Cascella

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for adults with schizophrenia who still have severe symptoms like hallucinations and delusions, even after trying several antipsychotic medications (including clozapine). Participants must have no other treatment options left and continue to be significantly disabled by their illness.

Inclusion Criteria

I am able to walk on my own.
I am not able to become pregnant or I use birth control and have negative pregnancy tests.
I have tried clozapine at a high dose for 12 weeks or could not tolerate it.
See 7 more

Exclusion Criteria

Participation in another investigational drug or therapeutic trial within 30 days of Baseline Visit 1
Presence of defibrillator, pacemaker, or implants interfering with MRI or device function
Unstable psycho-social condition including housing instability and poor support
See 8 more

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

  • Medtronic Percept with SensSight Deep Brain Stimulation System

Trial Overview

The study is testing deep brain stimulation (DBS) using the Medtronic Percept with SensSight system. Electrodes are placed in a specific brain area to see if this can help people whose schizophrenia hasn't improved with any available medicines.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Deep Brain Stimulation ImplantExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials
2,366
Recruited
15,160,000+

Citations

Percept™ PC Neurostimulator

The Medtronic DBS System for Epilepsy has demonstrated safety and effectiveness for patients who average six or more seizures per month over the three most ...

Deep Brain Stimulation for Treatment-Resistant ...

This pilot study will investigate the use of DBS in treatment-resistant schizophrenia subjects who have exhausted all other therapeutic alternatives but ...

Deep Brain Stimulation in Treatment Resistant Schizophrenia

This pilot study will investigate the use of DBS in treatment-resistant schizophrenia subjects who have exhausted all other therapeutic alternatives but ...

Deep brain stimulation in treatment resistant schizophrenia

This initial trial suggests that DBS might be beneficial in some patients with treatment resistant schizophrenia. Of particular note was the near-complete ...

Deep Brain Stimulation for Schizophrenia

Deep brain stimulation (DBS) has shown promise in treating treatment-resistant schizophrenia, with four out of seven patients meeting symptomatic response ...