Assessing brain activity in schizophrenia using TMS
TMS Related Biomarker Assessments
This study is testing if a new brain stimulation technique can help improve thinking and symptoms in people with schizophrenia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Maryland, Baltimore Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT05660018 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of repetitive transcranial magnetic stimulation (rTMS) on patients with schizophrenia spectrum disorder. Participants will undergo both active and sham rTMS sessions, with assessments of schizophrenia-related biomarkers conducted before and after the interventions. The goal is to identify TMS methods that can modulate brain activity and potentially improve cognitive functions and clinical symptoms associated with schizophrenia. The findings may lead to the development of targeted TMS treatments for this condition.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18-65 diagnosed with schizophrenia spectrum disorder.
Not a fit: Patients with a history of seizures or significant substance dependence may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new non-invasive treatments that improve cognitive function and reduce symptoms in patients with schizophrenia.
How similar studies have performed: Other studies have shown promise in using TMS for various mental health conditions, but this specific approach in schizophrenia is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male and Female between ages 18-65 * Ability to give written informed consent (age 18 or above) * Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above10. Exclusion Criteria: * Any history of seizures. * Significant alcohol or other drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence. * Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, CNS infection or tumor, other significant brain neurological conditions. * Taking \> 400 mg clozapine/day * Failed TMS screening questionnaire * Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed. * History of head injury with loss of consciousness over 10 minutes; history of brain surgery * Can not refrain from using alcohol and/or marijuana 24 hours or more \& cigarette smoking half and hour or more prior to experiments. * Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self report; or by positive pregnancy test) or has had unprotected sexual intercourse without birth control in the last 4 weeks.
Where this trial is running
Baltimore, Maryland
- University of Maryland, Baltimore — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Xiaoming Du, PhD — University of Maryland, Baltimore
- Study coordinator: Xiaoming Du, PhD
- Email: xdu@som.umaryland.edu
- Phone: 410-402-6036
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.