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Procedure

Deep Brain Stimulation for Schizophrenia

N/A
Recruiting
Led By Nicola Cascella
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subject has a diagnosis of schizophrenia or schizoaffective disorder as determined by a review of medical records, discussion with referring psychiatrist, and the Structured Clinical Interview for DSM-V (SCID-V)
Subject must be ambulatory
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year after neurostimulator implantation
Awards & highlights

Study Summary

This trial will investigate whether or not deep brain stimulation of the substantia nigra pars reticulata can help to treat symptoms in patients with treatment-resistant schizophrenia who have exhausted all other options.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects of DBS may include headache, seizure risk during implantation surgery, infection at the surgical site, bleeding in the brain or stroke-like symptoms. Long-term stimulation might cause mood changes or movement disorders.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with schizophrenia or schizoaffective disorder.
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I can walk on my own.
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My schizophrenia has not improved despite trying three different medications, including clozapine, for over a year.
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I am a woman who cannot become pregnant or am using birth control, and my pregnancy tests were negative.
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I have severe symptoms, including hallucinations, on the BPRS scale.
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I am 22 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year after neurostimulator implantation
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year after neurostimulator implantation for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from baseline in the Brief Psychiatric Rating Scale
Change from baseline in the Scales for the Assessment of Negative Symptoms (SANS)
Incidence of adverse device effects (ADEs).
Secondary outcome measures
Change from baseline in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) cognitive test battery.
Change from baseline in the Young Mania scale (YMS)

Trial Design

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.

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH
2,775 Previous Clinical Trials
2,673,738 Total Patients Enrolled
247 Trials studying Schizophrenia
89,402 Patients Enrolled for Schizophrenia
Johns Hopkins UniversityLead Sponsor
2,246 Previous Clinical Trials
14,816,780 Total Patients Enrolled
8 Trials studying Schizophrenia
934 Patients Enrolled for Schizophrenia
Nicola CascellaPrincipal InvestigatorJohns Hopkins University

Media Library

Deep Brain Stimulation (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT02361554 — N/A
Schizophrenia Research Study Groups: Deep Brain Stimulation Implant
Schizophrenia Clinical Trial 2023: Deep Brain Stimulation Highlights & Side Effects. Trial Name: NCT02361554 — N/A
Deep Brain Stimulation (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT02361554 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the participant sample size of this research endeavor?

"Affirmative. According to the clinicaltrials.gov data, this medical experiment was originally listed on June 1st 2012 and is actively recruiting participants at present. They anticipate that 3 individuals will join from a single site of study."

Answered by AI

Are there any vacancies still available for participants in this experiment?

"Affirmative. Records on clinicaltrials.gov demonstrate that the medical trial, first listed on June 1st 2012, is actively recruiting patients. Approximately 3 people are needed across one facility."

Answered by AI
~4 spots leftby Jun 2027