Improving brain connectivity in schizophrenia using neuromodulation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to enhance brain connectivity in patients with schizophrenia spectrum disorder through the use of active repetitive transcranial magnetic stimulation (rTMS) combined with cognitive training. The intervention focuses on improving white matter integrity in the frontal lobe, which is crucial for cognitive functions and emotional responses. By stimulating the brain's electrical signaling, the study seeks to promote myelination and potentially alleviate symptoms associated with schizophrenia. The efficacy of this combined approach has not been previously evaluated.

Why it matters

Who can join: the full rules

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 and not on anti-seizure medication(s) with sufficient dose.
5. Failed TMS screening questionnaire.
6. 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.
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 it's running

• 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: Bhim M Adhikari
• Email: bhim.m.adhikari@uth.tmc.edu
• Phone: 713-486-2740

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.