Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 1)

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

Study Overview

• Status: Not yet recruiting
• Conditions: Schizophrenia
• Intervention / Treatment: Device: active H-coil delivered rTMS

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xiaoming Du, PhD; Phone Number: 443-882-9717; Email: Xiaoming.Du@uth.tmc.edu
• Study Contact Backup: Name: Victoria M Acosta; Phone Number: 713-486-2740; Email: Victoria.Acosta@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77054
      • The University of Texas Health Science Center, Houston
      • Contact: Victoria Acosta; Phone Number: 713-486-2740; Email: Victoria.Acosta@uth.tmc.edu
      • Contact: Xiaoming Du, PhD; Phone Number: 410-402-6036; Email: Xiaoming.Du@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active rTMS; Participants in this group will receive active H-coil delivered rTMS.	Device: active H-coil delivered rTMS; Multiple trains of rTMS in a day, for multiple days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
brain microstructural integrity from magnetic resonance imaging (MRI)	The change of brain microstructural integrity from MRI scan will be used to represent the TMS effects on white matter.	2 weeks
Resting-state functional connectivity (rsFC) from functional MRI	The change of rsFC will be used to represent the TMS effects on brain connectivity.	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electrophysiological responses measured by mismatch negativity and steady-state auditory evoked potentials from electroencephalography recording (EEG)	The change of EEG signals represents the TMS effects on electrophysiological responses.	2 weeks
Cognitive insight, depression, perception, and delusion measured from questionnaires	The change of outcomes of those questionnaires represents the TMS effects on various symptoms of schizophrenia.	2 weeks
Cognitive functions measured by the MATRICS consensus cognitive battery (MCCB)	The changes of MCCB outcomes represents the TMS effects on cognitive functions of patients.	2 weeks

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Xiaoming Du, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: March 28, 2024
• First Submitted That Met QC Criteria: March 28, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 5, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: schizophrenia; Transcranial magnetic stimulation; connectivity; white matter; myelination
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: HSC-MS-23-1044

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No