Transcranial Magnetic Stimulation (TMS) for Negative Symptoms in Schizophrenia Spectrum Disorders

The University of Texas System (UT)

Status: Not yet enrolling

Conditions: Schizophrenia Spectrum Disorder

Treatments: Device: sham; Device: TMS

Study type: Interventional

Funder types: Other

Identifiers

NCT07290738

HSC-MS-25-0694

Details and patient eligibility

About

The purpose of this study is to determine if repetitive transcranial magnetic stimulation (rTMS) applied to angular gyrus (AG) will improve negative symptoms and/or other psychosis symptoms in schizophrenia spectrum disorders (SSD) patients compared with prefrontal cortex (PFC) or sham.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Ability to give written informed consent
• 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 negative symptoms as determined by BNSS score of 20 or more.
• Agrees to 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

Exclusion criteria

• 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 dependence within the recent months) or positive urine toxicology screen for substance not prescribed 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, Central nervous System (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
• 0 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 2 and NO to Question 6 (Moderate risk); or answers YES to Questions 3 (Moderate risk), 4, 5, or 6 (High risk) or in the clinical judgement of the investigator or the study psychiatrist.
• History (or family history) of deep vein thrombosis.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 4 patient groups

AG TMS

Experimental group

Treatment:

Device: TMS

PFC sham

Sham Comparator group

Treatment:

Device: sham

AG Sham

Sham Comparator group

Treatment:

Device: sham

PFC TMS

Active Comparator group

Treatment:

Device: TMS