Schizophrenia SchizoaffectiveNCT05660018
TMS Related Biomarker Assessments
A study of Schizophrenia Schizoaffective and Schizophrenia, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia Schizoaffective, Schizophrenia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jan 2023to 14 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore
Baltimore, Maryland, 21228
About this study
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.
Read the detailed description
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.
- Conditions
- Schizophrenia Schizoaffective, Schizophrenia
- Being tested
- active rTMS first, then sham rTMS, sham rTMS first, then active rTMS
- Keywords
- schizophrenia, Transcranial magnetic stimulation
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active rTMS first, then sham rTMSDevice
Active rTMS is delivered on the first visit, then sham rTMS is delivered on the second visit.
sham rTMS first, then active rTMSDevice
Sham rTMS is delivered on the first visit, then active rTMS is delivered on the second visit.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS first and sham rTMS second | Other | Participants in this arm will receive active rTMS in one visit first, then receive sham rTMS in another visit. Receives: Device: active rTMS first, then sham rTMS |
| Sham rTMS first and active rTMS second | Other | Participants in this arm will receive sham rTMS in one visit first, then receive active rTMS in another visit. Receives: Device: sham rTMS first, then active rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start7 Jan 2023
- Primary completion14 Feb 2025
- Study completion14 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Schizophrenia SchizoaffectiveStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoming Du, University of Maryland, Baltimore
- Investigators
- Xiaoming Du, PhD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05660018
- Sponsor's protocol ID
- HP-00103592
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2022
- Last updated
- 9 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TMS Related Biomarker Assessments
- ClinicalTrials.gov ID
- NCT05660018
- Acronym / sponsor ID
- HP-00103592
- Conditions
- Schizophrenia Schizoaffective, Schizophrenia
- Keywords
- schizophrenia, Transcranial magnetic stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 7 Jan 2023 (actual)
- Primary completion
- 14 Feb 2025 (actual)
- Study completion
- 14 Feb 2025 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Posted 9 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active rTMS first and sham rTMS second | Other | Device: active rTMS first, then sham rTMSParticipants in this arm will receive active rTMS in one visit first, then receive sham rTMS in another visit. |
| Sham rTMS first and active rTMS second | Other | Device: sham rTMS first, then active rTMSParticipants in this arm will receive sham rTMS in one visit first, then receive active rTMS in another visit. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| active rTMS first, then sham rTMSActive rTMS is delivered on the first visit, then sham rTMS is delivered on the second visit. | Device | Active rTMS first and sham rTMS second |
| sham rTMS first, then active rTMSSham rTMS is delivered on the first visit, then active rTMS is delivered on the second visit. | Device | Sham rTMS first and active rTMS second |
Primary outcome
Change of Resting-state Functional Connectivity (rsFC) by Active and Sham rTMS
Time frame: 2 weeks
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.
Change of Mismatch Negativity (MMN) From Electroencephalography (EEG) Signals by Active and Sham rTMS
Time frame: 2 weeks
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiaoming Du, PhD principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Schizophrenia Schizoaffective and Schizophrenia, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Resting-state Functional Connectivity (rsFC) by Active and Sham rTMS (time frame: 2 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2026.