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Schizophrenia Spectrum DisorderNCT07290738

Transcranial Magnetic Stimulation (TMS) for Negative Symptoms in Schizophrenia Spectrum Disorders

A study testing TMS in people with Schizophrenia Spectrum Disorder, run by The University of Texas Health Science Center, Houston at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The purpose of this study is to determine if repetitive transcranial magnetic stimulation (rTMS) applied to angular gyrus (AG) will improve negative symptoms and/or other psychosis symptoms in schizophrenia spectrum disorders (SSD) patients compared with prefrontal cortex (PFC) or sham. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Schizophrenia Spectrum Disorder
What is being tested?
TMS
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
20 participants
Where
1 siteUnited States
Study dates
13 Mar 2026to 30 Nov 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

  • Ability to give written informed consent
  • Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10.
  • Is currently under the care of a licensed primary care provider or mental healthcare provider (e.g., psychiatrist, psychologist, nurse practitioner, licensed clinical social worker).
  • Have negative symptoms as determined by BNSS score of 20 or more.
  • Agrees to provide written permission, as requested, to allow any and all forms of communication between the investigators and study staff and any health care provider who currently provides and/or has provided service to the subject within two years of study enrollment

Who cannot join

  • Persons with a first-degree relative with inherited epilepsy, seizure disorder, or seizures or persons who answer "yes" to any of the parts (A. - G.) of Question 3 of an epilepsy screening questionnaire.
  • 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 dependence within the recent months) or positive urine toxicology screen for substance not prescribed 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, Central nervous System (CNS)infection or tumor, other significant brain neurological conditions.
  • 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.
Show all 11Show fewer
  • History of head injury with loss of consciousness over 10 minutes; history of brain surgery
  • 0 Cannot refrain from using alcohol and/or marijuana 24 hours 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.
  • Moderate-High Risk of suicide according to the Columbia - Suicide Severity Rating Scale (C-SSRS) Screen Version - Recent (i.e. answers YES to Question 2 and NO to Question 6 (Moderate risk); or answers YES to Questions 3 (Moderate risk), 4, 5, or 6 (High risk) or in the clinical judgement of the investigator or the study psychiatrist.
  • History (or family history) of deep vein thrombosis.

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
  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

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

    Keiko Kunitoki, (713) 486-2700, Keiko.Kunitoki@uth.tmc.edu

    Recruiting

Other trials in United States

About this study

Official title: TMS for Negative Symptoms in Schizophrenia Spectrum Disorders

The purpose of this study is to determine if repetitive transcranial magnetic stimulation (rTMS) applied to angular gyrus (AG) will improve negative symptoms and/or other psychosis symptoms in schizophrenia spectrum disorders (SSD) patients compared with prefrontal cortex (PFC) or sham.

Being tested
TMS, sham

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • TMSDevice

    A wire coil is held on the scalp. Brief electrical currents are passed through the coil and create one or more magnetic pulses that stimulate the brain. For each TMS session, bursts of 3 pulses at 50 Hz are repeated at 5 Hz as a train for 2seconds. The inter-train interval is 8 seconds. There are 20 trains lasting 192 seconds (600pulses) per session. The intensity of TMS stimulations is set to 80-120% of resting motor threshold(RMT).

  • shamDevice

    Participants will receive total of 2 s of theta burst sham stimulation (TBS) trains repeated every 10 s for a total of 20 cycles (600 pulses). No actual magnetic stimulation will occur, still participant hears the TMS sound and a skin sensation

Study groups in NCT07290738
Study groupRoleWhat they receive
AG TMSExperimentalNot described
Receives: Device: TMS
PFC shamSham comparatorNot described
Receives: Device: sham
AG ShamSham comparatorNot described
Receives: Device: sham
PFC TMSActive comparatorNot described
Receives: Device: TMS

What is being measured

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

  1. Change in blood-brain barrier (BBB) water exchange rate at AG obtained from MRI scan

    Measured: baseline (before treatment visit 1), midpoint (after treatment visit 10; about 2 weeks from baseline), and end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

Secondary outcomes (19)
  1. Change in Negative symptoms as assessed by the Brief Negative Symptom Scale (BNSS)

    It includes 13 items across 6 domains: blunted affect, alogia, asociality, anhedonia, avolition, and lack of normal distress. Each item is scored from 0 to 6, with higher scores indicating more severe negative symptoms.

    The total score ranges from 0 to 78.

    Measured: at baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

  2. Change in Positive symptoms as assessed by the Positive and Negative Syndrome Scale (PANSS)

    It includes 30 items rated from 1 (absent) to 7 (extreme) across three subscales:

    Positive Symptoms (7 items; score range 7-49) Negative Symptoms (7 items; score range 7-49) General Psychopathology (16 items; score range 16-112) The PANSS Total Score ranges from 30 to 210, with higher scores indicating more severe symptoms. Change

    Measured: at baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

  3. Change in Cognitive function as assessed by Brief Assessment of Cognition in Schizophrenia (BACS): Symbol Coding

    Participants are asked to match symbols to numbers according to a key as quickly and accurately as possible within 90 seconds. Scores reflect the total number of correct responses, with higher scores indicating better cognitive performance.

    Measured: t baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

  4. Change in Working memory as assessed by the Number Span test

    The Number Span test evaluates working memory capacity by requiring participants to recall sequences of numbers in the same order (forward span) and/or reverse order (backward span). Scores represent the total number of correctly recalled sequences, with higher scores indicating better working memory performance.

    Measured: t baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

  5. Change in Working memory as assessed by the Wechsler Memory Scale-Third Edition (WMS-III): Spatial Span

    Participants observe a series of blocks tapped by the examiner and are asked to reproduce the sequence in the same order (Spatial Span Forward) and reverse order (Spatial Span Backward).

    Scores are based on the number of correctly reproduced sequences, with higher scores indicating better spatial working memory performance.

    Measured: t baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

  6. Change in Cognitive function as assessed by the Category Fluency Test: Animal naming (Fluency)

    participants are asked to name as many animals as possible within 60 seconds.

    The score is the total number of correct, non-repeated animal names, with higher scores indicating better semantic fluency.

    Measured: t baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

  7. Change in Cognitive function as assessed by the Rey-Osterrieth Complex Figure Test

    Participants are asked to copy a complex geometric figure and later reproduce it from memory after a delay.

    Scores are based on the accuracy and placement of figure components, with higher scores indicating better visuospatial and memory performance.

    Measured: t baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

  8. Change in Cognitive function as assessed by the Bell Lysaker Emotion Recognition Task

    Participants view brief video clips of an actor expressing various emotions (e.g., happiness, sadness, anger, fear, surprise, disgust, and neutrality) through facial expressions, vocal tone, and body language.

    Participants identify the emotion portrayed in each clip. Scores reflect the total number of correctly identified emotions, with higher scores indicating better emotion recognition ability.

    Measured: t baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

  9. Change in Cognitive function as assessed by the Hinting Task

    Participants read or listen to brief scenarios in which a character implies a desire or intention, and they must identify the underlying meaning.

    Scores reflect the total number of accurately interpreted hints, with higher scores indicating better theory of mind functioning.

    Measured: t baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

  10. Change in Depression as assessed by the Patient Health Questionnaire (PHQ-9)

    The PHQ-9 is a 9-item self-report questionnaire that measures depressive symptom severity over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day), yielding a total score range of 0-27, with higher scores indicating more severe depression.

    Measured: t baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

  11. Change in 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: t baseline, after treatment visit 10 (about 2 weeks from baseline), and at the end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

  12. Change in Resting state functional connectivity between AG and PFC assessed by functional MRI (fMRI)

    Measured: at baseline (before treatment visit 1), midpoint (after treatment visit 10; about 2 weeks from baseline), and end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

  13. Change in Activity level (number of steps per day) as assessed by smart wristwatch

    Measured: from baseline (before treatment visit 1) through end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

  14. Change in Location (number of unique places visited)as assessed by smart wristwatch

    Measured: from baseline (before treatment visit 1) through end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

  15. Change in Sleep (number of hours slept per day) as assessed by smart wristwatch

    Measured: from baseline (before treatment visit 1) through end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

  16. Change in Speech (pitch, intonation, pause) as assessed by video recording of speech

    Measured: baseline, after treatment visit 10 (about 2 weeks from baseline), and end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

  17. Change in facial expression (neutral, positive, and negative facial features) as assessed by video recording of speech

    Measured: baseline, after treatment visit 10 (about 2 weeks from baseline), and end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

  18. Change in Electrophysiological responses as indicated by mismatch negativity as measured 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 (before treatment visit 1) and end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

  19. Change in Electrophysiological response as indicated by steadystate 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 (before treatment visit 1) and end of acute treatment (after treatment visit 20; about 4 weeks from baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study start13 Mar 2026
  3. Primary completion30 Nov 2030 (estimated)
  4. Study completion30 Nov 2030 (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
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07290738
Sponsor's protocol ID
HSC-MS-25-0694
Status last verified
Mar 2026
First submitted
26 Nov 2025
Last updated
24 Mar 2026
Results posted
No
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 TMS in people with Schizophrenia Spectrum Disorder, 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 5 inclusion and 11 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 24 Mar 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. Some participants in this study may receive a placebo. 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 Xiaoming Du, PhD (443-882-9717, Xiaoming.Du@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in blood-brain barrier (BBB) water exchange rate at AG obtained from MRI scan (time frame: baseline (before treatment visit 1), midpoint (after treatment visit 10; about 2 weeks from baseline), and end of acute treatment (after treatment visit 20; about 4 weeks from baseline)). 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 24 Mar 2026.

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