Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 3)

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT07772349
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

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

Interventions

  • Active rTMS — DEVICE
    Active H-coil delivered rTMS sessions will be given three times per treatment visit for up to 10 visits within about 2 weeks. There are about 30 minutes breaks between adjacent TMS sessions. Each TMS session takes about 3 to 4 minutes to complete.
  • Strong Cognitive Training — BEHAVIORAL
    For the cognitive training sessions, patients will be asked to play cognitive computer games involving processing speed tasks for about 15 to 30 minutes. Strong cognitive training is intended to significantly enhance cognitive functions
  • Sham rTMS — DEVICE
    Sham H-coil delivered rTMS sessions will be given three times per treatment visit for up to 10 visits within about 2 weeks. There are about 30 minutes breaks between adjacent TMS sessions. Each TMS session takes about 3 to 4 minutes to complete. In case of sham TMS, no actual magnetic stimulation will occur, still the participant hears the TMS sound and a skin sensation.
  • Weak Cognitive Training — BEHAVIORAL
    For the cognitive training sessions, patients will be asked to play cognitive computer games involving processing speed tasks for about 15 to 30 minutes. Weak cognitive training may yield only modest improvements in cognitive functions.

Study Details

The aim of the study is to assess the treatment effects of deep active repetitive transcranial magnetic stimulation (rTMS) with H4 coil combined with cognitive training for improving frontal white matter microstructural integrity in patients with schizophrenia spectrum disorder (SSD).

Key Dates

First listed
Aug 19, 2026
Start date
Oct 1, 2026
Status verified
Aug 2026
Primary completion
May 1, 2029
Completion
May 1, 2029

Study Design

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

Arms

  • Experimental: Active rTMS Combined with Strong Cognitive Training
    Participants will receive active H-coil delivered rTMS, as well as strong cognitive training in each treatment visit for up to 10 treatment visits within about 2 weeks. In each visit, there are three rTMS sessions and each of them is followed by a cognitive training session and a rest period, which allows the inter-rTMS-session interval to be about 30 minutes. The cognitive training includes several cognitive computer games that are meant to improve the speed and accuracy of performance--strong cognitive training is intended to significantly enhance cognitive functions.
  • Experimental: Active rTMS Combined with Weak Cognitive Training
    Participants will receive active H-coil delivered rTMS, as well as weak cognitive training in each treatment visit for up to 10 treatment visits within about 2 weeks. In each visit, there are three rTMS sessions and each of them is followed by a cognitive training session and a rest period, which allows the inter-rTMS-session interval to be about 30 minutes. The cognitive training includes several cognitive computer games that are meant to improve the speed and accuracy of performance--weak cognitive training may yield only modest improvements in cognitive functions.
  • Experimental: Sham rTMS Combined with Strong Cognitive Training
    Participants will receive sham H-coil delivered rTMS, as well as strong cognitive training in each treatment visit for up to 10 treatment visits within about 2 weeks. In each visit, there are three rTMS sessions and each of them is followed by a cognitive training session and a rest period, which allows the inter-rTMS-session interval to be about 30 minutes. In case of sham TMS, no actual magnetic stimulation will occur, still the participant hears the TMS sound and a skin sensation. The cognitive training includes several cognitive computer games that are meant to improve the speed and accuracy of performance--strong cognitive training is intended to significantly enhance cognitive functions.
  • Experimental: Sham rTMS Combined with Weak Cognitive Training
    Participants will receive sham H-coil delivered rTMS, as well as weak cognitive training in each treatment visit for up to 10 treatment visits within about 2 weeks. In each visit, there are three rTMS sessions and each of them is followed by a cognitive training session and a rest period, which allows the inter-rTMS-session interval to be about 30 minutes. In case of sham TMS, no actual magnetic stimulation will occur, still the participant hears the TMS sound and a skin sensation. The cognitive training includes several cognitive computer games that are meant to improve the speed and accuracy of performance--weak cognitive training may yield only modest improvements in cognitive functions.

Primary Outcome Measure

Brain microstructural integrity as indicated by white matter fractional anisotropy (FA) values as assessed by magnetic resonance imaging (MRI) [ Time Frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas Health Science Center, HoustonHoustonTexas77054
Xiaoming Du, PhD
443-882-9717
Bhim Adhikari
713-486-2740

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