RecruitingNot ApplicableNCT07060066

Bilateral Prefrontal and Insular TMS for Depression in Schizophrenia


Sponsor

The University of Texas Health Science Center, Houston

Enrollment

120 participants

Start Date

May 21, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 60 Years

Inclusion Criteria4

  • 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.
  • Score of Calgary depression scale for schizophrenia (CDSS) ≥ 3.

Exclusion Criteria7

  • Inability to sign informed consent.
  • Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but are not limited to: stroke, repeated seizure, history of significant head trauma with cognitive sequela, CNS infection or tumor, other significant brain neurological conditions.
  • Significant alcohol or other drug use other than nicotine or marijuana dependence.
  • Inability to refrain from using alcohol and/or marijuana 24 hours or more prior to experiments.
  • Pregnancy, as classified by a woman of child-bearing potential who is not using a contraceptive and has missed a menstrual period; or by self-report; or by positive urine pregnancy test.
  • For MRI, inability to participate in the 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 declining to get in the scanner.
  • Failed TMS safety questionnaire.

Interventions

DEVICEActive rTMS stimulation

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.

DEVICESham rTMS stimulation

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.


Locations(1)

The University of Texas Health Science Center at Houston

Houston, Texas, United States

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NCT07060066


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