Closed Loop Neuromodulation for Treatment-refractory Schizophrenia: A Pilot Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Objectives: 1. Use intracranial mapping (SEEG) combined with pharmacological manipulation of psychotic states to create a protocol for participant specific deep brain stimulation to treat treatment-refractory schizophrenia. 2. Develop closed loop stimulation protocols to modify brain states during psychotic brain activity induced by low-dose ketamine administration. 3. Investigate the use of mnemonic similarity to characterize brain networks related to symptoms of treatment-refractory schizophrenia. 4. Treatment-related objectives: Record a reduction in psychotic symptoms, as well as an improvement in psychosocial function and cognition.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 22
Maximum Age: 70
Healthy Volunteers: f
View:

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

• Diagnostic and Statistical Manual of Mental Disorders (DSM) -5 diagnosis (assessed by Structured Clinical Interview for DSM-5 Axis I disorders SCID-5) of schizophrenia as the primary diagnosis.

• Medically healthy, without any acute serious medical disorders

• Treatment refractory and previous trials of treatment defined as: Demonstrated non-sustained response to at least two different antipsychotic drugs from two different chemical families. And demonstrated non-sustained response to at least either an electroconvulsive therapy (ECT) or a clozapine trial.

• Suffering from active and ongoing psychotic symptoms of a continuous and aversive nature.

• The PANSS must remain greater than or equal to 90 on two separate assessments (at initial screening and 1 week before surgery), over a 1-month period;

• At least one item on the PANSS positive subscale is 5 or greater.

• Normal brain MRI within 3 months of surgery;

• Stable antipsychotic medication regimen for the month preceding surgery;

⁃ Normal thyroid stimulating hormone (TSH) level within 12 months of study entry;

⁃ Other medical conditions must be stable for at least 6 months;

⁃ Able and willing to give informed consent and agree to attend regular clinic visits for at least 12 months following surgery;

⁃ Able to have a treating psychiatrist or close relative present for discussions about the study and co-sign informed consent;

⁃ Willingness to sign Treatment Contract.

⁃ Participants with a family or caregiver support system to aid the participant throughout the study will be preferentially selected for inclusion.

⁃ For women of childbearing potential:

∙ Required to provide a negative pregnancy blood test during screening phase of the study, and during several additional timepoints throughout study participation.

‣ Obligated to use highly effective (those that when used alone or in combination, result in a low failure rate \[i.e., less than 1 percent per year\], when used consistently and correctly) methods of birth control throughout study participation.

‣ Will be allowed to participate in the study only after a confirmed menstrual period.

⁃ For men: Obligated to use highly effective (those that when used alone or in combination, result in a low failure rate \[i.e., less than 1 percent per year\], when used consistently and correctly) methods of birth control throughout study participation.

Locations
United States
Texas
UT Southwestern Medical Center
RECRUITING
Dallas
Contact Information
Primary
Hila Abush Segev, Ph.D
Hila.AbushSegev@UTSouthwestern.edu
214-648-0401
Time Frame
Start Date: 2024-04-03
Estimated Completion Date: 2027-04
Participants
Target number of participants: 10
Treatments
Experimental: Randomized Discontinuation Period: OFF then ON DBS
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.
Experimental: Experimental: Randomized Discontinuation Period: ON then OFF DBS
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.
Related Therapeutic Areas
Sponsors
Leads: Bradley Lega

This content was sourced from clinicaltrials.gov