Bilateral Prefrontal and Insular TMS for Depression in Schizophrenia

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07060066
Status
Recruiting
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Conditions

  • Schizophrenia and Related Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

  • Active rTMS stimulation — DEVICE
    Active H-coil delivered rTMS sessions will be given three times per treatment visit for up to 20 visits for about 4 weeks. There are about 30 minutes breaks between adjacent TMS sessions. Each TMS session takes about 3 to 4 minutes to complete.
  • Sham rTMS stimulation — DEVICE
    Sham H-coil delivered rTMS sessions will be given three times per treatment visit for up to 20 visits for about 4 weeks. There are about 30 minutes breaks between adjacent TMS sessions. Each TMS session takes about 3 to 4 minutes to complete.

Study Details

The purpose of this study is to provide an effective repetitive transcranial magnetic stimulation (rTMS) treatment for depressive symptoms in patients with schizophrenia. Schizophrenia patients with depressive symptoms will be exposed to rTMS to improve their symptoms.

Key Dates

Start date
May 21, 2024
Status verified
Dec 2025
Primary completion
Jun 1, 2030
Completion
Jun 1, 2030

Study Design

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

Arms

  • Active Comparator: Active rTMS stimulation
    Participants will receive active H-coil delivered rTMS in each treatment visit for up to 20 treatment visits for about 4 weeks. In each visit, there are three rTMS sessions with inter-rTMS-session interval of about 30 minutes.
  • Sham Comparator: Sham rTMS stimulation
    Participants will receive sham H-coil delivered rTMS in each treatment visit for up to 20 treatment visits for about 4 weeks. In each visit, there are three rTMS sessions with inter-rTMS-session interval of about 30 minutes.

Primary Outcome Measure

Brain connectivity as indicated by resting-state functional connectivity (rsFC) values as assessed by functional MRI (fMRI) [ Time Frame: baseline, visit 11 (about 2 week after baseline), visit 21 (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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