Bilateral prefrontal and insular TMS to treat depression in schizophrenia.
Bilateral Prefrontal and Insular TMS for Depression in Schizophrenia
This trial will try repetitive transcranial magnetic stimulation (rTMS) with an H4 coil over both prefrontal and insular brain areas to see if it reduces depressive symptoms in adults with schizophrenia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (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 | NCT07060066 on ClinicalTrials.gov |
What this trial studies
Adults with schizophrenia and depressive symptoms will receive either active or sham rTMS delivered with an H4 coil that targets bilateral insula and prefrontal cortices. Treatment sessions are delivered in person at the study site and depressive symptoms are measured with the Calgary Depression Scale for Schizophrenia (CDSS). Eligible participants are ages 18–60, able to give informed consent, and have a CDSS score of 3 or higher. Major neurological illness, active problematic substance use, pregnancy, or inability to consent are exclusion criteria.
Who should consider this trial
Good fit: Adults 18–60 with a diagnosed schizophrenia-spectrum disorder, able to consent, and with at least mild depressive symptoms (CDSS ≥ 3) are the intended participants.
Not a fit: People with major neurological disorders, significant current substance misuse, pregnant people, those unable to consent, or those outside the age range are unlikely to be eligible or benefit from this protocol.
Why it matters
Potential benefit: If effective, this approach could reduce depressive symptoms in people with schizophrenia and improve quality of life and functioning.
How similar studies have performed: Standard TMS has proven benefits for major depressive disorder, but no prior TMS trials have specifically targeted depression in schizophrenia with the H4 coil, so this application is novel though based on established TMS effects.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and female ages between ages 18-60 years. * Ability to give written informed consent (age 18 or above). * Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10. * Score of Calgary depression scale for schizophrenia (CDSS) ≥ 3. Exclusion Criteria: * Inability to sign informed consent. * Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but are not limited to: stroke, repeated seizure, history of significant head trauma with cognitive sequela, CNS infection or tumor, other significant brain neurological conditions. * Significant alcohol or other drug use other than nicotine or marijuana dependence. * Inability to refrain from using alcohol and/or marijuana 24 hours or more prior to experiments. * Pregnancy, as classified by a woman of child-bearing potential who is not using a contraceptive and has missed a menstrual period; or by self-report; or by positive urine pregnancy test. * For MRI, inability to participate in the MRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips or other implanted metal parts) or declining to get in the scanner. * Failed TMS safety questionnaire.
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: Alina Siatka
- Email: Alina.Siatka@uth.tmc.edu
- Phone: 713-486-2740
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.