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NCT07772349

Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 3)

Sponsor: The University of Texas Health Science Center, Houston

View on ClinicalTrials.gov

Summary

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 Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2026-10-01

Completion Date

2029-05-01

Last Updated

2026-08-19

Healthy Volunteers

Conditions

Schizophrenia

Interventions

DEVICE

Active rTMS

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.

BEHAVIORAL

Strong Cognitive Training

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

DEVICE

Sham rTMS

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.

BEHAVIORAL

Weak Cognitive Training

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.

Inclusion Criteria: 1. Male and female ages between ages 18-60 years 2. Ability to give written informed consent (age 18 or above) 3. Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10. Exclusion Criteria: 1. Inability to sign informed consent. 2. Any history of seizures. 3. Any acute and unstable major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, recent stroke, seizure, history of significant head trauma, CNS infection or tumor, other significant brain neurological conditions (As this is a study of medical comorbidity, most medical conditions, once stable, are not exclusion criteria). 4. Taking \> 400 mg clozapine/day and not on anti-seizure medication(s) with sufficient dose. 5. Failed TMS screening questionnaire. 6. 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. 7. A history of thrombosis, family history of thrombosis, or medical conditions that may lead to a hypercoagulable state (increased chance to develop blood clots) 8. Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self-report; or by positive urine pregnancy test). 9. History of head injury with loss of consciousness over 10 minutes; history of brain surgery 10. Cannot refrain from using alcohol and/or marijuana 24 hours or more prior to experiments. 11. Students and employees currently involved with our lab (lab employees and personnel will be excluded from the study to avoid possible coercion or possible appearance of coercion, or chance of breach of privacy and confidentiality). 12. For MRI, unable to undergo MRI scanning due to metallic devices or objects (cardiac pacemaker or neurostimulator, some artificial joints, metal pins, surgical clips, or other implanted metal parts) or claustrophobic to the scanner.

Locations (1)

The University of Texas Health Science Center, Houston

Houston, Texas, United States