An interventional study of active rTMS first, then sham rTMS and sham rTMS first, then active rTMS in Schizophrenia Schizoaffective and Schizophrenia, sponsored by University of Maryland, Baltimore. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-01-09.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Other
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.
Electrical neural oscillations of the brain can be measured at many levels, ranging from single cell to local field potentials in animals, to large-scale synchronized activities in the human scalp. New evidence suggests that there may be common underlying abnormalities in oscillatory activities that are associated with schizophrenia-related cognitive and functional impairments. There is currently no treatment for these electrical oscillation dysfunctions. Transcranial magnetic stimulation (TMS) provides a non-invasive means for altering brain electrical neural activity. TMS has been approved by FDA for the treatment of depression and many other mental disorders. It has been used in a wide range of clinical research, especially in neurology and psychiatry. The investigators aim to develop TMS paradigms that will modulate brain responses during basic sensory to more complex cognitive performance and determine the parameters in anatomic locations and TMS modalities that may effectively and safely modulate neural activities. If the current experiments successfully identified TMS methods/paradigms that improve neural oscillation and cognitive performances in schizophrenia patients, in the future (not part of the current protocol), the investigators can then develop specific TMS treatment that may correct abnormal brain function and improve cognition and clinical symptoms of schizophrenia.
1,626 studies on the registry are indexed under Psychotic Disorders; 293 are open to participants now.
This study's enrollment of 10 is below the median of 70 across 1,333 interventional studies indexed under Psychotic Disorders.
Browse Psychotic Disorders studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
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Exclusion Criteria:
Participants in this arm will receive active rTMS in one visit first, then receive sham rTMS in another visit.
Device: active rTMS first, then sham rTMS
Participants in this arm will receive sham rTMS in one visit first, then receive active rTMS in another visit.
Device: sham rTMS first, then active rTMS
Active rTMS is delivered on the first visit, then sham rTMS is delivered on the second visit.
Sham rTMS is delivered on the first visit, then active rTMS is delivered on the second visit.
Change of Resting-state Functional Connectivity (rsFC) by Active and Sham rTMS
The strength of rsFC was first defined by correlation coefficient (r). Because the distribution of r values is highly skewed, z scores (normally distributed) were computed via fisher r-to-z transform. The z score central value (i.e., z score of 0) represents no relationship between the two brain regions. A positive (negative) z score indicates a positive (negative) association between the two brain regions. Stronger rsFC (i.e., larger positive z score) was related to stronger connection between the two brain regions. The differences of rsFC between active and sham were reported. A positive (negative) value of rsFC change suggests the rsFC was enhanced (weakened) by active TMS.
Time frame: 2 weeks
Change of Mismatch Negativity (MMN) From Electroencephalography (EEG) Signals by Active and Sham rTMS
TMS effect is explored by comparing MMN changes from active and sham rTMS. MMN is measured by subtracting the averaged EEG response to a set of standard stimuli from the averaged response to rarer deviant stimuli, and taking the amplitude of this difference wave in a given time window. The differences of MMN between active and sham were reported. A negative (positive) value of rsFC change suggests the MMN was enhanced (weakened) by active TMS.
Time frame: 2 weeks
| Milestone | Active rTMS First and Sham rTMS Second | Sham rTMS First and Active rTMS Second |
|---|---|---|
| Started | 5 | 5 |
| Completed | 5 | 5 |
| Not completed | 0 | 0 |
The strength of rsFC was first defined by correlation coefficient (r). Because the distribution of r values is highly skewed, z scores (normally distributed) were computed via fisher r-to-z transform. The z score central value (i.e., z score of 0) represents no relationship between the two brain regions. A positive (negative) z score indicates a positive (negative) association between the two brain regions. Stronger rsFC (i.e., larger positive z score) was related to stronger connection between the two brain regions. The differences of rsFC between active and sham were reported. A positive (negative) value of rsFC change suggests the rsFC was enhanced (weakened) by active TMS.
| z score of functional connectivity | Active rTMS | Sham rTMS |
|---|---|---|
| Change of Resting-state Functional Connectivity (rsFC) by Active and Sham rTMS | 0.018 ± 0.018 | 0.007 ± 0.027 |
TMS effect is explored by comparing MMN changes from active and sham rTMS. MMN is measured by subtracting the averaged EEG response to a set of standard stimuli from the averaged response to rarer deviant stimuli, and taking the amplitude of this difference wave in a given time window. The differences of MMN between active and sham were reported. A negative (positive) value of rsFC change suggests the MMN was enhanced (weakened) by active TMS.
| microvolts | Active rTMS | Sham rTMS |
|---|---|---|
| Change of Mismatch Negativity (MMN) From Electroencephalography (EEG) Signals by Active and Sham rTMS | -0.106 ± 0.367 | 0.044 ± 0.217 |
Collected over From baseline to the time when the participant completes or quits the study (up to 1 month).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active rTMS | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Sham rTMS | 0/10 (0%) | 0/10 (0%) | 0/10 (0%) |
| Age, Categorical(Participants) | Active rTMS First and Sham rTMS Second | Sham rTMS First and Active rTMS Second | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 5 | 5 | 10 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Active rTMS First and Sham rTMS Second | Sham rTMS First and Active rTMS Second | Total |
|---|---|---|---|
| Mean | 38.8 ± 18.2 | 39.2 ± 16.2 | 39.0 ± 16.2 |
| Sex: Female, Male(Participants) | Active rTMS First and Sham rTMS Second | Sham rTMS First and Active rTMS Second | Total |
|---|---|---|---|
| Female | 3 | 3 | 6 |
| Male | 2 | 2 | 4 |
| Ethnicity (NIH/OMB)(Participants) | Active rTMS First and Sham rTMS Second | Sham rTMS First and Active rTMS Second | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 5 | 5 | 10 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Active rTMS First and Sham rTMS Second | Sham rTMS First and Active rTMS Second | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 4 | 3 | 7 |
| White | 1 | 2 | 3 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Active rTMS First and Sham rTMS Second | Sham rTMS First and Active rTMS Second | Total |
|---|---|---|---|
| United States | 5 | 5 | 10 |
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University of Maryland, Baltimore