Improving brain connectivity in schizophrenia using neuromodulation
Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 2)
This study is testing whether a combination of brain stimulation and cognitive training can improve brain function and help people with schizophrenia feel better.
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 | NCT06961916 on ClinicalTrials.gov |
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.
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 illnesses 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 reduced symptoms in patients with schizophrenia.
How similar studies have performed: While the use of rTMS has been explored in various contexts, the specific combination with cognitive training for myelination modulation in schizophrenia is a novel approach.
Eligibility criteria
Show full inclusion / exclusion 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 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 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: Bhim M Adhikari
- Email: bhim.m.adhikari@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.