About this trial
The purpose of the study is to test the hypothesis that functionally navigated repetitive TMS stimulations to the prefrontal cortex (PFC) modulate aberrant cortical electrical activities at PFC circuitry. The TMS location of the PFC site will be individually localized by the symptom-related functional connectivity between PFC and symptom related areas (such as the auditory and language processing cortex). The investigators predict that such modulation will correct abnormal activities in patients with schizophrenia, reduce symptoms, especially auditory hallucination, and improve working memory/sustained attention performance.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male and female ages between ages 18-50 years
Ability to give written informed consent (age 18 or above)
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).
Disqualifiers
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 abuse within 1 month or substance dependence history within 6 months and having substance usage within 1 month) other than nicotine or marijuana dependence
Trial design
Parallel
Treatments tested in this trial
Active rTMS stimulation
DeviceParticipants will receive two rTMS sessions in each treatment visit for up to 22 visits within about 6 weeks. There is a 30-minute rest between the two rTMS sessions.
Sham rTMS stimulation
DeviceParticipants will receive two sham rTMS sessions in each treatment visit for up to 22 visits within about 6 weeks. There is a 30-minute rest between the two sham rTMS sessions.
Treatment groups
Trial outcomes
Primary outcomes
Brain connectivity as indicated by resting state functional connectivity value as assessed by functional magnetic resonance imaging (fMRI)
Functional magnetic resonance imaging (fMRI) is used to evaluate the brain activities that are corresponding to the treatment effect on auditory hallucination.
Secondary outcomes
Electrophysiological responses as indicated by mismatch negativity amplitudes from electroencephalography recording (EEG)
Electroencephalogram (EEG) is used to evaluate the brain electrical activities that are corresponding to the treatment effect on auditory hallucination.
Electrophysiological responses as indicated by steady-state auditory evoked potentials from electroencephalography recording (EEG)
Electroencephalogram (EEG) is used to evaluate the brain electrical activities that are corresponding to the treatment effect on auditory hallucination.
Auditory hallucinations as assessed by Psychotic Symptom Rating Scale (PSYRATS)
Total score ranges from 0 to 44, with a lower score indicating a better outcome.
Negative symptoms as assessed by Brief Negative Symptom Scale (BNSS)
Total score ranges from 0 to 90, with a lower score indicating a better outcome.
Sponsors and contacts
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The University of Texas Health Science Center, Houston
Lead sponsor
National Institute of Mental Health (NIMH)
Collaborator