← Back to Search

Procedure

Randomized Discontinuation Period: OFF then ON DBS for Schizophrenia

N/A

Recruiting

Led By Bradley Lega, M.D.

Research Sponsored by Bradley Lega

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men and women (non-pregnant) between ages 22 and 70

For men: Use of highly effective birth control

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Awards & highlights

Study Summary

This trial aims to use a new therapy involving Deep Brain Stimulation (DBS) and stereo electroencephalogram (SEEG) mapping to treat schizophrenia that doesn't respond well to current treatments

Who is the study for?

This trial is for individuals with treatment-refractory schizophrenia, meaning their condition hasn't improved after trying other treatments. Participants will undergo a procedure to implant the Infinity™ DBS system and must be comfortable with intracranial mapping and potential ketamine administration.Check my eligibility

What is being tested?

The study tests the safety and effectiveness of Abbott Laboratories' Infinity™ deep brain stimulation system in managing schizophrenia symptoms. It involves brain mapping, machine learning techniques to identify non-psychotic states, and personalized stimulation protocols.See study design

What are the potential side effects?

While specific side effects are not listed, participants will be monitored for any serious adverse events related to the DBS system or procedure over eight months. The goal is to confirm that this intervention is safe for chronic use.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 22 and 70 years old and not pregnant.

Select...

I am using a highly effective method of birth control.

Select...

My primary diagnosis is schizophrenia.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Demonstrate device safety

Trial Design

2Treatment groups

Experimental Treatment

Group I: Randomized Discontinuation Period: OFF then ON DBSExperimental Treatment1 Intervention

Subjects randomized to this arm are initially "OFF" DBS after the open label period then gradually decreased in their optimized setting's amplitude for 8 weeks and then "ON" DBS for 8 weeks.

Group II: Experimental: Randomized Discontinuation Period: ON then OFF DBSExperimental Treatment1 Intervention

Subjects randomized to this arm are initially "ON" DBS with optimized stimulation settings for 8 weeks after the open label period and then "OFF" DBS with gradually decreasing amplitude for 8 weeks.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bradley LegaLead Sponsor

Bradley Lega, M.D.Principal InvestigatorUT Southwestern Medical Center

David McDonagh, M.D.Principal InvestigatorUT Southwestern Medical Center

Frequently Asked Questions

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

Which individuals are eligible to take part in this research investigation?

"To be eligible for enrollment, individuals must have a diagnosis of schizophrenia and fall between the ages of 22 and 70. The study is currently accepting approximately 10 participants."

Answered by AI

Is this clinical trial actively seeking participants at the moment?

"As per the details on clinicaltrials.gov, recruitment for this trial is currently closed. The study was first made available on April 1st, 2024 and last updated on February 5th, 2024. Although this specific trial is not actively enrolling participants at the moment, there are numerous other trials with openings for enrollment."

Answered by AI

Is the age limit for participation in this research set below 40 years?

"Patient eligibility for this clinical trial specifies an age range from 22 to 70 years. Notably, there are a total of 44 studies focusing on individuals under the age of 18 and another 174 trials targeting those over the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Deep Brain Stimulation for Psychosis

Bradley Lega 2024. "Deep Brain Stimulation for Psychosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06257056.

All > Dallas > Fort Worth