Medtronic Activa Deep Brain Stimulation System for Treatment Resistant Schizophrenia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Treatment Resistant Schizophrenia+1 More
Medtronic Activa Deep Brain Stimulation System - Device
Eligibility
18+
All Sexes
What conditions do you have?
Select

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.

Eligible Conditions
  • Treatment Resistant Schizophrenia

Treatment Effectiveness

Study Objectives

3 Primary · 2 Secondary · Reporting Duration: 1 year after neurostimulator implantation

Year 1
Change from baseline in the Brief Psychiatric Rating Scale
Change from baseline in the Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) cognitive test battery.
Change from baseline in the Scales for the Assessment of Negative Symptoms (SANS)
Change from baseline in the Young Mania scale (YMS)
Incidence of adverse device effects (ADEs).

Trial Safety

Trial Design

1 Treatment Group

Deep Brain Stimulation Implant
1 of 1

Experimental Treatment

3 Total Participants · 1 Treatment Group

Primary Treatment: Medtronic Activa Deep Brain Stimulation System · No Placebo Group · N/A

Deep Brain Stimulation Implant
Device
Experimental Group · 1 Intervention: Medtronic Activa Deep Brain Stimulation System · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 1 year after neurostimulator implantation

Who is running the clinical trial?

Johns Hopkins UniversityLead Sponsor
2,055 Previous Clinical Trials
30,975,411 Total Patients Enrolled
Nicola CascellaPrincipal InvestigatorJohns Hopkins University

Eligibility Criteria

Age 18+ · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
People who are unable to tolerate clozapine at a dose of 400 mg or for 12 weeks because of intolerable side effects are also eligible for the trial.
The subject had severe conceptual disorganization and hallucinatory behavior at all three baseline visits, and severe unusual thought content at two of the baseline visits
The subject can read, understand and cooperate with the study procedures, and they have signed a written consent form prior to any study procedures.
The subject is determined by an independent psychiatrist with expertise in capacity assessments to have decision-making capacity to provide informed consent.
The patient has received adequate trials of two different antipsychotic drugs belonging to different classes within the previous 5 years
Females who are postmenopausal, physically incapable of childbearing, or practicing an acceptable method of birth control
The subject must be able to walk.
People aged at least 22 years old of either gender.
Subject has been diagnosed with schizophrenia after studying their medical records, talking to the referring psychiatrist, and using the Structured Clinical Interview for DSM-IV (SCID-IV).

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 12th, 2021

Last Reviewed: November 22nd, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.