RecruitingNot ApplicableNCT06961916

Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 2)


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

120 participants

Start Date

Jun 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from H coil combined with cognitive training for improving white matter integrity.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria3

  • Male and female ages between ages 18-60 years
  • Ability to give written informed consent (age 18 or above)
  • Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above 10.

Exclusion Criteria11

  • Inability to sign informed consent.
  • Any history of seizures.
  • Taking > 400 mg clozapine/day and not on anti-seizure medication(s) with sufficient dose.
  • Failed TMS screening questionnaire.
  • 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.
  • A history of thrombosis, family history of thrombosis, or medical conditions that may lead to a hypercoagulable state (increased chance to develop blood clots)
  • 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).
  • History of head injury with loss of consciousness over 10 minutes; history of brain surgery
  • Cannot refrain from using alcohol and/or marijuana 24 hours or more prior to experiments.
  • 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).
  • 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.

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Interventions

DEVICEActive 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.

BEHAVIORALCognitive 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.


Locations(1)

The University of Texas Health Science Center, Houston

Houston, Texas, United States

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NCT06961916


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