Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 1)

NCT ID: NCT06345963

Last Updated: 2025-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-21

Study Completion Date

2030-05-01

Brief Summary

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

Detailed Description

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Schizophrenia is a severe mental illness that affects about 1% of the population but a major source of disability. Information processing between brain regions occurs due to transfer of electrical impulses among them. This process is determined by the existing neuronal/fiber connections, which may be altered and or modified in the presence of neuronal stimulation or cognitive intervention. The frontal lobe information flow is critical for higher cognitive functions, thought processes, and proper emotional and behavioral responses. Improving the myelination in the frontal lobe may increase cognitive functions and reduce risks to develop symptoms of schizophrenia. The investigators propose that increasing electrical signaling in the frontal white matter in patients with schizophrenia may also enhance myelination and improve the white matter integrity.

The patients with schizophrenia will receive active repetitive transcranial magnetic stimulation (rTMS) treatment. The rTMS with H coil is FDA-cleared for short-term smoking cessation in the general population. Its efficacy in myelination modulation has not been evaluated.

Conditions

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Schizophrenia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Active rTMS

Participants in this group will receive active H-coil delivered rTMS.

Group Type EXPERIMENTAL

active H-coil delivered rTMS

Intervention Type DEVICE

Multiple trains of rTMS in a day, for multiple days.

Interventions

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active H-coil delivered rTMS

Multiple trains of rTMS in a day, for multiple days.

Intervention Type DEVICE

Eligibility Criteria

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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.
4. Taking \> 400 mg clozapine/day.
5. Failed TMS screening questionnaire.
6. Significant alcohol or other drug use (substance dependence within 6 months or substance abuse 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of Texas Health Science Center, Houston

OTHER

Sponsor Role lead

Responsible Party

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Xiaoming Du

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Xiaoming Du, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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The University of Texas Health Science Center, Houston

Houston, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Victoria M Acosta

Role: CONTACT

713-486-2740

Xiaoming Du, PhD

Role: CONTACT

443-882-9717

Facility Contacts

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Xiaoming Du, PhD

Role: primary

410-402-6036

Victoria Acosta

Role: backup

713-486-2740

Other Identifiers

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HSC-MS-23-1044 (study 1)

Identifier Type: -

Identifier Source: org_study_id

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