AzTrials
AzTrials

SchizophreniaNCT07772349

Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 3)

A study testing Active rTMS, Strong Cognitive Training and Weak Cognitive Training in people with Schizophrenia, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial 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). 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 rTMS, Strong Cognitive Training and Weak Cognitive Training
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
120 participants
Where
1 siteUnited States
Study dates
1 Oct 2026to 1 May 2029
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 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.
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
  • The University of Texas Health Science Center, Houston

    Houston, Texas, 77054

    Xiaoming Du, PhD, 443-882-9717, Xiaoming.Du@uth.tmc.edu

    Bhim Adhikari, 713-486-2740, bhim.m.adhikari@uth.tmc.edu

Other trials in United States

About this study

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).

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.

rTMS with H coil is FDA-cleared for short-term smoking cessation in the general population. The efficacy of its combination with cognitive training in myelination modulation has not been evaluated.

Conditions
Schizophrenia
Being tested
Active rTMS, Strong Cognitive Training, Sham rTMS, Weak Cognitive Training
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 rTMSDevice

    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.

  • Strong Cognitive TrainingBehavioural

    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 rTMSDevice

    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.

  • Weak Cognitive TrainingBehavioural

    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.

Study groups in NCT07772349
Study groupRoleWhat they receive
Active rTMS Combined with Strong Cognitive TrainingExperimentalParticipants 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.
Receives: Device: Active rTMS; Behavioral: Strong Cognitive Training
Active rTMS Combined with Weak Cognitive TrainingExperimentalParticipants 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.
Receives: Device: Active rTMS; Behavioral: Weak Cognitive Training
Sham rTMS Combined with Strong Cognitive TrainingExperimentalParticipants 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.
Receives: Behavioral: Strong Cognitive Training; Device: Sham rTMS
Sham rTMS Combined with Weak Cognitive TrainingExperimentalParticipants 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.
Receives: Device: Sham rTMS; Behavioral: Weak Cognitive Training

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

  2. 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)
  1. 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)

  2. 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 ratio will be obtained in a given timepoint.

    Measured: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)

  3. 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)

  4. 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,

  5. 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)

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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)

  11. 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

  12. 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)

  13. 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)

  14. 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.

  1. First posted19 Aug 2026
  2. Study start1 Oct 2026 (estimated)
  3. Primary completion1 May 2029 (estimated)
  4. Study completion1 May 2029 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07772349
Sponsor's protocol ID
HSC-MS-23-1044 (study 3)
Status last verified
Aug 2026
First submitted
13 Aug 2026
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Active rTMS, Strong Cognitive Training and Weak Cognitive Training 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: opening soon, as of the sponsor's last update on 19 Aug 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 Bhim M Adhikari (713-486-2740, bhim.m.adhikari@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 19 Aug 2026.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT07772349 | AzTrials