Transcranial Magnetic Stimulation (TMS) for Negative Symptoms in Schizophrenia Spectrum Disorders
NCT ID: NCT07290738
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
20 participants
INTERVENTIONAL
2025-12-29
2030-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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AG TMS
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).
PFC sham
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
AG Sham
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
PFC TMS
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).
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
No
Sponsors
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The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Xiaoming Du
Assistant Professor
Principal Investigators
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Xiaoming Du, PhD
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Locations
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The University of Texas Health Science Center at Houston
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Xiaoming Du, PhD
Role: primary
Keiko Kunitoki
Role: backup
Other Identifiers
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HSC-MS-25-0694
Identifier Type: -
Identifier Source: org_study_id