Alternative Stimulation Mode and Location for Auditory Hallucination Neuromodulation Treatment

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT02916810
Status
Recruiting
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Conditions

  • Schizophrenia and Related Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 50 Years
Healthy Volunteers
Not accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Feb 1, 2025
Status verified
Jul 2025
Primary completion
Jul 1, 2029
Completion
Jul 1, 2029

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active rTMS stimulation
  • Sham Comparator: Sham rTMS stimulation

Primary Outcome Measure

Brain connectivity as indicated by resting state functional connectivity value as assessed by functional magnetic resonance imaging (fMRI) [ 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) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center at HoustonHoustonTexas77030
Xiaoming Du, PhD
[email protected]
713-486-2700

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By research site
The University of Texas Health Science Center at Houston· Houston, TX

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