Recruiting

rTMS vs. PFC

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT07290738

Conditions

Schizophrenia Spectrum Disorder

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

TMS

sham

Study Details

Brief 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.

Conditions

Schizophrenia Spectrum Disorder

Study ID

NCT07290738

Start date

Mar 13, 2026

Status verified date

Mar, 2026

Completion date

Nov 30, 2030

Anticipated

Primary completion date

Nov 30, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: AG TMS

sham comparator: PFC sham

sham comparator: AG Sham

active comparator: PFC TMS

Interventions

TMS

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).

sham

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

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) ]

Central Contacts and Locations

Central contacts

Xiaoming Du, PhD

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

Keiko Kunitoki

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

Locations

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Xiaoming Du, PhD

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

Keiko Kunitoki

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

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Mar 24, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-03-24.