Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 3)
1 other identifier
interventional
120
1 country
1
Brief Summary
The aim of the study is to assess the treatment effects of deep active repetitive transcranial magnetic stimulation (rTMS) with H4 coil combined with cognitive training for improving frontal white matter microstructural integrity in patients with schizophrenia spectrum disorder (SSD).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable schizophrenia
Started Oct 2026
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2026
CompletedFirst Posted
Study publicly available on registry
August 19, 2026
CompletedStudy Start
First participant enrolled
October 1, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2029
Study Completion
Last participant's last visit for all outcomes
May 1, 2029
August 19, 2026
August 1, 2026
2.6 years
August 13, 2026
August 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
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.
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)
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)
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
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)
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,
Depression as assessed by the Depression State and Trait Scale (DST) - state
baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
- +9 more secondary outcomes
Study Arms (4)
Active rTMS Combined with Strong Cognitive Training
EXPERIMENTALParticipants will receive active H-coil delivered rTMS, as well as strong cognitive training in each treatment visit for up to 10 treatment visits within about 2 weeks. In each visit, there are three rTMS sessions and each of them is followed by a cognitive training session and a rest period, which allows the inter-rTMS-session interval to be about 30 minutes. The cognitive training includes several cognitive computer games that are meant to improve the speed and accuracy of performance--strong cognitive training is intended to significantly enhance cognitive functions.
Active rTMS Combined with Weak Cognitive Training
EXPERIMENTALParticipants will receive active H-coil delivered rTMS, as well as weak cognitive training in each treatment visit for up to 10 treatment visits within about 2 weeks. In each visit, there are three rTMS sessions and each of them is followed by a cognitive training session and a rest period, which allows the inter-rTMS-session interval to be about 30 minutes. The cognitive training includes several cognitive computer games that are meant to improve the speed and accuracy of performance--weak cognitive training may yield only modest improvements in cognitive functions.
Sham rTMS Combined with Strong Cognitive Training
EXPERIMENTALParticipants will receive sham H-coil delivered rTMS, as well as strong cognitive training in each treatment visit for up to 10 treatment visits within about 2 weeks. In each visit, there are three rTMS sessions and each of them is followed by a cognitive training session and a rest period, which allows the inter-rTMS-session interval to be about 30 minutes. In case of sham TMS, no actual magnetic stimulation will occur, still the participant hears the TMS sound and a skin sensation. The cognitive training includes several cognitive computer games that are meant to improve the speed and accuracy of performance--strong cognitive training is intended to significantly enhance cognitive functions.
Sham rTMS Combined with Weak Cognitive Training
EXPERIMENTALParticipants will receive sham H-coil delivered rTMS, as well as weak cognitive training in each treatment visit for up to 10 treatment visits within about 2 weeks. In each visit, there are three rTMS sessions and each of them is followed by a cognitive training session and a rest period, which allows the inter-rTMS-session interval to be about 30 minutes. In case of sham TMS, no actual magnetic stimulation will occur, still the participant hears the TMS sound and a skin sensation. The cognitive training includes several cognitive computer games that are meant to improve the speed and accuracy of performance--weak cognitive training may yield only modest improvements in cognitive functions.
Interventions
Active H-coil delivered rTMS sessions will be given three times per treatment visit for up to 10 visits within about 2 weeks. There are about 30 minutes breaks between adjacent TMS sessions. Each TMS session takes about 3 to 4 minutes to complete.
For the cognitive training sessions, patients will be asked to play cognitive computer games involving processing speed tasks for about 15 to 30 minutes. Strong cognitive training is intended to significantly enhance cognitive functions
Sham H-coil delivered rTMS sessions will be given three times per treatment visit for up to 10 visits within about 2 weeks. There are about 30 minutes breaks between adjacent TMS sessions. Each TMS session takes about 3 to 4 minutes to complete. In case of sham TMS, no actual magnetic stimulation will occur, still the participant hears the TMS sound and a skin sensation.
For the cognitive training sessions, patients will be asked to play cognitive computer games involving processing speed tasks for about 15 to 30 minutes. Weak cognitive training may yield only modest improvements in cognitive functions.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Inability to sign informed consent.
- Any history of seizures.
- Taking \> 400 mg clozapine/day and not on anti-seizure medication(s) with sufficient dose.
- Failed TMS screening questionnaire.
- Significant alcohol or other drug use (substance abuse within 1 month or substance dependence history within 6 months and having substance usage within 1 month) other than nicotine or marijuana dependence.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of Texas Health Science Center, Houston
Houston, Texas, 77054, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaoming Du, PhD
The University of Texas Health Science Center, Houston
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 13, 2026
First Posted
August 19, 2026
Study Start (Estimated)
October 1, 2026
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
May 1, 2029
Last Updated
August 19, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will not share