Alternative Stimulation Mode and Location for Auditory Hallucination Neuromodulation Treatment

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorThe University of Texas Health Science Center, Houston

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Active rTMS stimulation

    Device

    Participants 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

    Device

    Participants 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

140 Participants
are divided into 2 treatment groups
Group A: Active rTMS stimulationActive comparator 1 intervention
Group B: Sham rTMS stimulationSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
baseline, intermittent (before or at the beginning of treatment visit 11, about 2 weeks after baseline), end of acute treatment (after treatment visit 20, about 4 weeks after baseline)

Secondary outcomes

1

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.

Time frame
baseline, intermittent (before or at the beginning of treatment visit 11, about 2 weeks after baseline), end of acute treatment (after treatment visit 20, about 4 weeks after baseline)
2

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.

Time frame
baseline, intermittent (before or at the beginning of treatment visit 11, about 2 weeks after baseline), end of acute treatment (after treatment visit 20, about 4 weeks after baseline)
3

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.

Time frame
baseline, intermittent (before or at the beginning of treatment visit 11, about 2 weeks after baseline), end of acute treatment (after treatment visit 20, about 4 weeks after baseline)
4

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.

Time frame
baseline, intermittent (before or at the beginning of treatment visit 11, about 2 weeks after baseline), end of acute treatment (after treatment visit 20, about 4 weeks after baseline)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Texas Health Science Center, Houston

Lead sponsor

National Institute of Mental Health (NIMH)

Collaborator