RecruitingNot ApplicableNCT02916810

Alternative Stimulation Mode and Location for Auditory Hallucination Neuromodulation Treatment

Sponsor

The University of Texas Health Science Center, Houston

Enrollment

140 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Schizophrenia and Related Disorders

Summary

The purpose of the study is to test the hypothesis that functionally navigated repetitive TMS stimulations to the prefrontal cortex (PFC) modulate aberrant cortical electrical activities at PFC circuitry. The TMS location of the PFC site will be individually localized by the symptom-related functional connectivity between PFC and symptom related areas (such as the auditory and language processing cortex). The investigators predict that such modulation will correct abnormal activities in patients with schizophrenia, reduce symptoms, especially auditory hallucination, and improve working memory/sustained attention performance.

Eligibility

Min Age: 18 YearsMax Age: 50 Years

Inclusion Criteria6

Male and female ages between ages 18-50 years
Ability to give written informed consent (age 18 or above)
Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10.
Is currently under the care of a licensed primary care provider or mental healthcare provider (e.g., psychiatrist, psychologist, nurse practitioner, licensed clinical social worker).
Have auditory hallucinations despite treated by two or more antipsychotics including one atypical antipsychotic medication.
Agrees to: (a) provide written permission, as requested, to allow any and all forms of communication between the investigators and study staff and any health care provider who currently provides and/or has provided service to the subject within two years of study enrollment; and (b) provide the names and verifiable contact information (name, email and mailing address, mobile and land-line phone number, as applicable) of at least two reliable persons ≥ age 22, who reside within a 30-minute drive of the subject's residence, and whom the research staff is at liberty to contact, as deemed necessary, for the duration of study participation.

Exclusion Criteria12

Persons with a first-degree relative with inherited epilepsy, seizure disorder, or seizures or persons who answer "yes" to any of the parts (A. - G.) of Question 3 of an epilepsy screening questionnaire.
Taking \> 400 mg clozapine/day and not on anti-seizure medication(s) with sufficient dose.
Failed TMS screening questionnaire.
Significant alcohol or other drug use (substance abuse within 1 month or substance dependence history within 6 months and having substance usage within 1 month) other than nicotine or marijuana dependence
Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, CNS infection or tumor, other significant brain neurological conditions.
Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
History of head injury with loss of consciousness over 10 minutes; history of brain surgery
Cannot refrain from using alcohol and/or marijuana 24 hours or more prior to experiments.
Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive pregnancy test) or has had unprotected sexual intercourse without birth control in the last 4 weeks.
Moderate-High Risk of suicide according to the Columbia - Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (i.e. answers YES to Question 3 and NO to Question 6 (Moderate risk); or answers YES to Questions 4, 5, or 6 (High risk) or in the clinical judgement of the investigator or the study psychiatrist.
In the medical opinion of the investigator, subjects with the following circumstances or conditions which can increase the risk of seizures may be excluded: sleep deprivation; major depressive disorder comorbid with dementia, underweight status; concurrent use of cephalosporins and antiarrhythmics (particularly propranolol); metabolic abnormalities (hyponatremia, hypocalcemia, hypomagnesemia, hypoglycemia, hyperglycemia, renal failure/uremia, liver failure); raised blood concentrations of proconvulsant medications due to reduced clearance (e.g. secondary to initiation of antibiotics for treatment of infections); alcohol withdrawal; use of stimulants, such as cocaine or MDMA; use of immunosuppressive therapy with cyclosporine, tacrolimus and other agents that can cause the posterior reversible leukoencephalopathy syndrome; dialysis; systemic infection, and fever itself.
History (or family history) of deep vein thrombosis.

Interventions

DEVICEActive rTMS stimulation

Participants will receive two rTMS sessions in each treatment visit for up to 22 visits within about 6 weeks. There is a 30-minute rest between the two rTMS sessions.

DEVICESham rTMS stimulation

Participants will receive two sham rTMS sessions in each treatment visit for up to 22 visits within about 6 weeks. There is a 30-minute rest between the two sham rTMS sessions.