N/A
N=10
TMS Related Biomarker Assessments
Schizophrenia Schizoaffective · Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT05660018 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Change of Resting-state Functional Connectivity (rsFC) by Active and Sham rTMS — 0.018; 0.007 z score of functional connectivity
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- active rTMS first, then sham rTMS (Device); sham rTMS first, then active rTMS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Maryland, Baltimore
- Primary completion
- Feb 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Resting-state Functional Connectivity (rsFC) by Active and Sham rTMS |
0.018; 0.007 | — |
| PRIMARY Change of Mismatch Negativity (MMN) From Electroencephalography (EEG) Signals by Active and Sham rTMS |
-0.106; 0.044 | — |
Summary
Patients with schizophrenia spectrum disorder (SSD) will be exposed to active and sham repetitive transcranial magnetic stimulation (rTMS) in separate sessions. SSD-related biomarkers will be assessed before and after the rTMS administration.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT05660018). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.