Schizophrenia Clinical Trial
Official title:
Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 1)
Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from H coil for improving white matter integrity.
Status | Not yet recruiting |
Enrollment | 120 |
Est. completion date | May 1, 2030 |
Est. primary completion date | May 1, 2029 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | The University of Texas Health Science Center, Houston | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center, Houston |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | brain microstructural integrity from magnetic resonance imaging (MRI) | The change of brain microstructural integrity from MRI scan will be used to represent the TMS effects on white matter. | 2 weeks | |
Primary | Resting-state functional connectivity (rsFC) from functional MRI | The change of rsFC will be used to represent the TMS effects on brain connectivity. | 2 weeks | |
Secondary | Electrophysiological responses measured by mismatch negativity and steady-state auditory evoked potentials from electroencephalography recording (EEG) | The change of EEG signals represents the TMS effects on electrophysiological responses. | 2 weeks | |
Secondary | Cognitive insight, depression, perception, and delusion measured from questionnaires | The change of outcomes of those questionnaires represents the TMS effects on various symptoms of schizophrenia. | 2 weeks | |
Secondary | Cognitive functions measured by the MATRICS consensus cognitive battery (MCCB) | The changes of MCCB outcomes represents the TMS effects on cognitive functions of patients. | 2 weeks |
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