SchizophreniaNCT06345963
Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 1)
A study testing active H-coil delivered rTMS in people with Schizophrenia, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from H coil for improving white matter integrity. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- active H-coil delivered rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2024to 1 May 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female ages between ages 18-60 years
- Ability to give written informed consent (age 18 or above)
- Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10.
Who cannot join
- Inability to sign informed consent.
- Any history of seizures.
- 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).
- Taking > 400 mg clozapine/day.
- Failed TMS screening questionnaire.
- Significant alcohol or other drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence.
Show all 12Show fewer
- A history of thrombosis, family history of thrombosis, or medical conditions that may lead to a hypercoagulable state (increased chance to develop blood clots)
- 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).
- History of head injury with loss of consciousness over 10 minutes; history of brain surgery
- Cannot refrain from using alcohol and/or marijuana 24 hours or more prior to experiments.
- 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).
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
The University of Texas Health Science Center, Houston
Houston, Texas, 77054
Xiaoming Du, PhD, 410-402-6036, Xiaoming.Du@uth.tmc.edu
Victoria Acosta, 713-486-2740, Victoria.Acosta@uth.tmc.edu
About this study
Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from H coil for improving white matter integrity.
Read the detailed description
Schizophrenia is a severe mental illness that affects about 1% of the population but a major source of disability. Information processing between brain regions occurs due to transfer of electrical impulses among them. This process is determined by the existing neuronal/fiber connections, which may be altered and or modified in the presence of neuronal stimulation or cognitive intervention. The frontal lobe information flow is critical for higher cognitive functions, thought processes, and proper emotional and behavioral responses. Improving the myelination in the frontal lobe may increase cognitive functions and reduce risks to develop symptoms of schizophrenia. The investigators propose that increasing electrical signaling in the frontal white matter in patients with schizophrenia may also enhance myelination and improve the white matter integrity.
The patients with schizophrenia will receive active repetitive transcranial magnetic stimulation (rTMS) treatment. The rTMS with H coil is FDA-cleared for short-term smoking cessation in the general population. Its efficacy in myelination modulation has not been evaluated.
- Conditions
- Schizophrenia
- Being tested
- active H-coil delivered rTMS
- Keywords
- Transcranial magnetic stimulation, schizophrenia, white matter, connectivity, myelination
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
active H-coil delivered rTMSDevice
Multiple trains of rTMS in a day, for multiple days.
| Study group | Role | What they receive |
|---|---|---|
| Active rTMS | Experimental | Participants in this group will receive active H-coil delivered rTMS. Receives: Device: active H-coil delivered rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain microstructural integrity as indicated by white matter fractional anisotropy (FA) values as assessed by magnetic resonance imaging (MRI)
Fractional anisotropy (FA) values will be reported. FA values range from 0 to 1 with larger values indicating greater white matter integrity.
Measured: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Brain connectivity as indicated by resting-state functional connectivity (rsFC) values as assessed by functional MRI (fMRI)
rsFC values will be reported as a Z-score with a range of -1 to 1, with greater absolute values indicating stronger brain connectivity.
Measured: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Secondary outcomes (14)
Electrophysiological response as indicated by mismatch negativity as assessed by electroencephalography (EEG)
Mismatch negativity values will be reported in microvolts (uV). Mismatch negativity is measured by subtracting the averaged response to a set of standard stimuli from the average response to deviant stimuli, and taking the amplitude of this difference in a given timepoint.
Measured: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Electrophysiological response as indicated by steady-state auditory evoked responses from electroencephalography recording (EEG)
Steady-state auditory evoked responses will be reported. The responses are measured by calculating the ratio of the power at target frequency over power at the surrounding background frequencies. The ration will be obtained in a given timepoint.
Measured: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Cognitive insight as assessed by the Beck Cognitive Insight Scale
Total score will be reported and ranges from 15 to 60, with a higher score indicating greater cognitive insight.
Measured: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Depression as assessed by the Depression State and Trait Scale (DST) - state
Total score of the state subscale of the DST will be reported and ranges from 0 to 72, with a higher score indicating greater depression state.
Measured: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Depression as assessed by the Depression State and Trait Scale (DST) - trait
Total score of the trait subscale of the DST will be reported and ranges from 0 to 72, with a higher score indicating greater depression trait.
Measured: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Depression as assessed by the Calgary Depression Scale
Total score of the Calgary Depression Scale will be reported and ranges from 0 to 27, with a higher score indicating greater depression.
Measured: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Depression as assessed by the Beck Depression Inventory
Total score of the Beck Depression Inventory will be reported and ranges from 0 to 63, with a higher score indicating greater depression.
Measured: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Perception as assessed by the Perception State and Trait Scale - state
The Perception State and Trait Scale assesses alterations in the perception of audio and visual experiences. Total score ranges from 0 to 96 for the state subscale, and a higher score indicates a greater alteration of audio or visual experiences state.
Measured: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Perception as assessed by the Perception State and Trait Scale - trait
The Perception State and Trait Scale assesses alterations in the perception of audio and visual experiences. Total score ranges from 0 to 96 for the trait subscale, and a higher score indicates a greater alteration of audio or visual experiences trait.
Measured: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Delusion as assessed by the 21-item Peters Delusion Inventory (PDI-21)
Total score will be reported and ranges from 0 to 21, with a higher score indicating greater delusion.
Measured: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Emotion regulation as assessed by the Profile of Mood States (POMS)
Total score will be reported and ranges from 0 to 204, with a higher score indicating more positive emotion and mood. This outcome measure will be assessed at each of the 10 treatment visits (which are about day 1 after baseline, day 2 after baseline, day 3 after baseline, day 4 after baseline, day 5 after baseline, day 9 after baseline, day 10 after baseline, respectively).
Measured: day 1 after baseline, day 2 after baseline, day 3 after baseline, day 4 after baseline, day 5 after baseline, day 9 after baseline, day 10 after baseline
Hallucination as assessed by the Revised Hallucinations Scale (RHS)
Total score will be reported and ranges from 0 to 13, with a higher score indicating greater hallucination. This outcome measure will be assessed at each of the 10 treatment visits (which are about day 1 after baseline, day 2 after baseline, day 3 after baseline, day 4 after baseline, day 5 after baseline, day 9 after baseline, day 10 after baseline, respectively).
Measured: day 1 after baseline, day 2 after baseline, day 3 after baseline, day 4 after baseline, day 5 after baseline, day 9 after baseline, day 10 after baseline
Cognitive function as assessed by the Letter-Number Span subscale of the MATRICS consensus cognitive battery (MCCB)
Total score will be reported and ranges from 0 to 24, with a higher score indicating greater cognitive function.
Measured: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Cognitive function as assessed by the Spatial Span subscale of the MATRICS consensus cognitive battery (MCCB)
Total score will be reported and ranges from 0 to 32, with a higher score indicating greater cognitive function.
Measured: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start21 May 2024
- Primary completion1 May 2029 (estimated)
- Study completion1 May 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoming Du, The University of Texas Health Science Center, Houston
- Investigators
- Xiaoming Du, PhD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345963
- Sponsor's protocol ID
- HSC-MS-23-1044 (study 1)
- Status last verified
- Jul 2026
- First submitted
- 28 Mar 2024
- Last updated
- 7 Jul 2026
- Results posted
- No
- 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 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 1)
- ClinicalTrials.gov ID
- NCT06345963
- Acronym / sponsor ID
- HSC-MS-23-1044 (study 1)
- Conditions
- Schizophrenia
- Keywords
- Transcranial magnetic stimulation, schizophrenia, white matter, connectivity, myelination
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 21 May 2024 (actual)
- Primary completion
- 1 May 2029 (estimated)
- Study completion
- 1 May 2030 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
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 repetitive transcranial magnetic stimulation (rTMS) from H coil for improving white matter integrity.
Detailed description
Schizophrenia is a severe mental illness that affects about 1% of the population but a major source of disability. Information processing between brain regions occurs due to transfer of electrical impulses among them. This process is determined by the existing neuronal/fiber connections, which may be altered and or modified in the presence of neuronal stimulation or cognitive intervention. The frontal lobe information flow is critical for higher cognitive functions, thought processes, and proper emotional and behavioral responses. Improving the myelination in the frontal lobe may increase cognitive functions and reduce risks to develop symptoms of schizophrenia. The investigators propose that increasing electrical signaling in the frontal white matter in patients with schizophrenia may also enhance myelination and improve the white matter integrity.
The patients with schizophrenia will receive active repetitive transcranial magnetic stimulation (rTMS) treatment. The rTMS with H coil is FDA-cleared for short-term smoking cessation in the general population. Its efficacy in myelination modulation has not been evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Active rTMS | Experimental | Device: active H-coil delivered rTMSParticipants in this group will receive active H-coil delivered rTMS. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Male and female ages between ages 18-60 years
- Ability to give written informed consent (age 18 or above)
- Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10.
Key exclusion criteria (12 listed)
- Inability to sign informed consent.
- Any history of seizures.
- 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).
- 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 H-coil delivered rTMSMultiple trains of rTMS in a day, for multiple days. | Device | Active rTMS |
Primary outcome
Brain microstructural integrity as indicated by white matter fractional anisotropy (FA) values as assessed by magnetic resonance imaging (MRI)
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Fractional anisotropy (FA) values will be reported. FA values range from 0 to 1 with larger values indicating greater white matter integrity.
Brain connectivity as indicated by resting-state functional connectivity (rsFC) values as assessed by functional MRI (fMRI)
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
rsFC values will be reported as a Z-score with a range of -1 to 1, with greater absolute values indicating stronger brain connectivity.
14 secondary outcomes
Electrophysiological response as indicated by mismatch negativity as assessed by electroencephalography (EEG)
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Electrophysiological response as indicated by steady-state auditory evoked responses from electroencephalography recording (EEG)
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Cognitive insight as assessed by the Beck Cognitive Insight Scale
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Depression as assessed by the Depression State and Trait Scale (DST) - state
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Depression as assessed by the Depression State and Trait Scale (DST) - trait
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Depression as assessed by the Calgary Depression Scale
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Depression as assessed by the Beck Depression Inventory
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Perception as assessed by the Perception State and Trait Scale - state
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Perception as assessed by the Perception State and Trait Scale - trait
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Delusion as assessed by the 21-item Peters Delusion Inventory (PDI-21)
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Emotion regulation as assessed by the Profile of Mood States (POMS)
Time frame: day 1 after baseline, day 2 after baseline, day 3 after baseline, day 4 after baseline, day 5 after baseline, day 9 after baseline, day 10 after baseline
Hallucination as assessed by the Revised Hallucinations Scale (RHS)
Time frame: day 1 after baseline, day 2 after baseline, day 3 after baseline, day 4 after baseline, day 5 after baseline, day 9 after baseline, day 10 after baseline
Cognitive function as assessed by the Letter-Number Span subscale of the MATRICS consensus cognitive battery (MCCB)
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Cognitive function as assessed by the Spatial Span subscale of the MATRICS consensus cognitive battery (MCCB)
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Schizophrenia
Recruiting
Magnetic Seizure Therapy for Schizophrenia - Trial
Treatment Resistant Schizophrenia, Schizophrenia
RecruitingPhase 2
Study to Evaluate the Safety and Efficacy of Ublituximab in Participants With Schizophrenia
Schizophrenia
RecruitingPhase 3
Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
Schizophrenia
Recruiting
Developing Biomarker-Supported Schizophrenia Spectrum Disorder (SSD) Prevention
Schizophrenia Spectrum Disorders (SSD)
Recruiting
Theta-Burst Transcranial Magnetic Stimulation for Treatment-Resistant Auditory Hallucinations
Auditory Verbal Hallucinations, Schizophrenia
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.
Xiaoming Du, PhD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing active H-coil delivered rTMS in people with Schizophrenia, run by The University of Texas Health Science Center, Houston 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 12 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: looking for participants now, as of the sponsor's last update on 7 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Victoria M Acosta (713-486-2740, Victoria.Acosta@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain microstructural integrity as indicated by white matter fractional anisotropy (FA) values as assessed by magnetic resonance imaging (MRI) (time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)). 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 7 Jul 2026; AzTrials last refreshed its copy on 1 Nov 2026.