Actively Recruiting
Alternative Stimulation Mode and Location for Auditory Hallucination Neuromodulation Treatment
Led by The University of Texas Health Science Center, Houston · Updated on 2025-07-28
140
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center, Houston
Lead Sponsor
N
National Institute of Mental Health (NIMH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating how repetitive transcranial magnetic stimulation (rTMS) targeting the prefrontal cortex can affect abnormal brain activity linked to schizophrenia symptoms, especially auditory hallucinations. The study aims to improve how TMS treatment is delivered by using brain scans to precisely locate stimulation areas related to symptoms, potentially helping reduce hallucinations and improve memory and attention. This research focuses on adults aged 18 to 50 with schizophrenia-spectrum disorders who still experience auditory hallucinations despite medication. Participants will be randomly assigned to receive either active or sham (placebo) rTMS treatments. Each treatment visit includes two rTMS sessions separated by a 30-minute rest, with up to 22 visits over about 6 weeks. The stimulation targets are individually identified using functional connectivity from brain imaging to maximize treatment effects. This personalized approach aims to improve the treatment's effectiveness compared to standard methods. During the study, participants undergo brain imaging with functional magnetic resonance imaging (fMRI) and electroencephalography (EEG) to measure brain connectivity and electrical responses at baseline, mid-treatment, and after treatment completion. Researchers also assess auditory hallucinations, negative symptoms, cognition, depression, perception, and delusions using various standardized scales. Safety and symptom changes are closely monitored throughout the trial, which runs from early assessments through about 4 weeks of active treatment.
CONDITIONS
Brief Title
Alternative Stimulation Mode and Location for Auditory Hallucination Neuromodulation Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female ages between 18 and 50 years
- Ability to give written informed consent
- Diagnosed with schizophrenia-spectrum disorder with Evaluation to Sign Consent (ESC) above 10
- Currently under care of a licensed primary care or mental healthcare provider
- Experiencing auditory hallucinations despite treatment with two or more antipsychotics including one atypical antipsychotic
- Agrees to allow communication between investigators and healthcare providers and to provide contact information for reliable persons nearby
You will not qualify if you...
- First-degree relative with inherited epilepsy or seizure disorder or positive epilepsy screening questionnaire
- Taking more than 400 mg clozapine per day without sufficient anti-seizure medication
- Failed TMS screening questionnaire
- Significant recent substance abuse or dependence except nicotine or marijuana
- Major medical illnesses affecting brain function such as stroke or brain tumor
- Presence of cardiac pacemakers, implanted pumps, intracardiac lines, intracranial implants, or metal objects near the head that cannot be removed
- History of head injury with loss of consciousness over 10 minutes or brain surgery
- Unable to refrain from alcohol or marijuana use 24 hours before experiments
- Pregnant women or those with recent unprotected sex without birth control
- Moderate to high risk of suicide as assessed by Columbia-Suicide Severity Rating Scale
- Conditions increasing seizure risk such as sleep deprivation, metabolic abnormalities, use of certain medications, alcohol withdrawal, systemic infection, or fever
- History or family history of deep vein thrombosis
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - About 6 weeks
Participants receive two rTMS sessions in each treatment visit with a 30-minute rest between sessions. This occurs for up to 22 visits within about 6 weeks.
Up to 22 treatment visits
Trial Site Locations
Total: 1 location
1
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
X
Xiaoming Du, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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