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 — DEVICEActive 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 — BEHAVIORALFor 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 — DEVICESham 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 — BEHAVIORALFor 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 TrainingParticipants 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 TrainingParticipants 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 TrainingParticipants 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 TrainingParticipants 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
- Bhim M Adhikari713-486-2740
- Xiaoming Du, PhD443-882-9717
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| The University of Texas Health Science Center, Houston | Houston | Texas | 77054 |
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