Improving brain connectivity in schizophrenia using neuromodulation

Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 1)

This study is testing whether a special type of brain stimulation can help improve thinking and emotional responses in people with schizophrenia by enhancing the brain's white matter.

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: NCT06345963 on ClinicalTrials.gov

What this trial studies

This study aims to enhance white matter integrity in patients with schizophrenia spectrum disorder through active repetitive transcranial magnetic stimulation (rTMS) using an H coil. The intervention focuses on improving electrical signaling in the frontal lobe, which is crucial for cognitive functions and emotional responses. By potentially increasing myelination in the frontal white matter, the study seeks to improve cognitive functions and reduce the risk of developing schizophrenia symptoms. The rTMS technique used is FDA-cleared for short-term smoking cessation but has not been evaluated for its effects on myelination modulation.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18-60 diagnosed with schizophrenia spectrum disorder who can provide informed consent.

Not a fit: Patients with a history of seizures or significant acute medical conditions affecting brain function may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to improved cognitive functions and better management of schizophrenia symptoms.

How similar studies have performed: While the use of rTMS has shown promise in other contexts, its specific application for enhancing myelination in schizophrenia is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

1. Male and female ages between ages 18-60 years
2. Ability to give written informed consent (age 18 or above)
3. Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10.

Exclusion Criteria:

1. Inability to sign informed consent.
2. Any history of seizures.
3. Any acute and unstable major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, recent stroke, seizure, history of significant head trauma, CNS infection or tumor, other significant brain neurological conditions (As this is a study of medical comorbidity, most medical conditions, once stable, are not exclusion criteria).
4. Taking \> 400 mg clozapine/day.
5. Failed TMS screening questionnaire.
6. Significant alcohol or other drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence.
7. A history of thrombosis, family history of thrombosis, or medical conditions that may lead to a hypercoagulable state (increased chance to develop blood clots)
8. Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive urine pregnancy test).
9. History of head injury with loss of consciousness over 10 minutes; history of brain surgery
10. Cannot refrain from using alcohol and/or marijuana 24 hours or more prior to experiments.
11. Students and employees currently involved with our lab (lab employees and personnel will be excluded from the study to avoid possible coercion or possible appearance of coercion, or chance of breach of privacy and confidentiality).
12. For MRI, unable to undergo 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 claustrophobic to the scanner.

Where this trial is running

Houston, Texas

• The University of Texas Health Science Center, Houston — Houston, Texas, United States (Recruiting)

Study contacts

• Principal investigator: Xiaoming Du, PhD — The University of Texas Health Science Center, Houston
• Study coordinator: Victoria M Acosta

Conditions Schizophrenia; Transcranial magnetic stimulation; schizophrenia; white matter; connectivity; myelination