Transcranial magnetic stimulation to reduce negative symptoms in schizophrenia-spectrum disorders
TMS for Negative Symptoms in Schizophrenia Spectrum Disorders
This trial will test whether repetitive transcranial magnetic stimulation (rTMS) to the angular gyrus can reduce negative and other psychosis symptoms in adults with schizophrenia-spectrum disorders compared with prefrontal stimulation or sham.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT07290738 on ClinicalTrials.gov |
What this trial studies
This interventional study randomizes adults with schizophrenia-spectrum disorders and prominent negative symptoms (BNSS ≥20) to receive rTMS targeted to the angular gyrus, rTMS to the prefrontal cortex, or sham stimulation. Participants must be able to give informed consent and be under ongoing primary or mental healthcare, with exclusions for seizure risk and certain high-dose clozapine regimens. Symptom severity will be measured before and after the intervention using standardized clinical scales to determine change in negative symptoms and other psychosis features. The study is conducted at The University of Texas Health Science Center at Houston and involves in-person treatment visits.
Who should consider this trial
Good fit: Ideal candidates are adults with a schizophrenia-spectrum diagnosis who have prominent negative symptoms (BNSS score ≥20), can give informed consent, and can attend in-person visits in Houston while not having seizure risk or contraindicated medications.
Not a fit: People with a high seizure risk, certain high-dose clozapine regimens without protective anti-seizure medication, or without significant negative symptoms are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could reduce negative symptoms and improve daily functioning for people with schizophrenia-spectrum disorders.
How similar studies have performed: Prior rTMS trials targeting the prefrontal cortex have shown mixed but sometimes positive results for negative symptoms, while angular gyrus targeting is a newer, relatively untested approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Houston, Texas
- The University of Texas Health Science Center at Houston — Houston, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Xiaoming Du, PhD — The University of Texas Health Science Center, Houston
- Study coordinator: Xiaoming Du, PhD
- Email: Xiaoming.Du@uth.tmc.edu
- Phone: 443-882-9717
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.