Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 2)

NCT ID: NCT06961916

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-03
• Study Completion Date: 2029-05-01

Brief 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.

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 combined with cognitive training. The rTMS with H coil is FDA-cleared for short-term smoking cessation in the general population. The efficacy of its combination with cognitive training in myelination modulation has not been evaluated.

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Active rTMS combined with Cognitive Training

Participants will receive active H-coil delivered rTMS, as well as cognitive training in each treatment visit for up to 10 treatment visits within about 2 weeks. In each visit, there are three rTMS sessions and each of them is followed by a cognitive training session and a rest period, which allows the inter-rTMS-session interval to be about 30 minutes.

Group Type: EXPERIMENTAL

Active rTMS

Intervention Type: DEVICE

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.

Cognitive Training

Intervention Type: BEHAVIORAL

For the cognitive training sessions, patients will be asked to play cognitive computer games involving processing speed tasks for about 15 to 30 minutes.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Health Science Center, Houston

OTHER

Sponsor Role: lead

Responsible Party

Xiaoming Du

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xiaoming Du, PhD

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

The University of Texas Health Science Center, Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Bhim M Adhikari

Role: CONTACT

bhim.m.adhikari@uth.tmc.edu

713-486-2740

Xiaoming Du, PhD

Role: CONTACT

Xiaoming.Du@uth.tmc.edu

443-882-9717

Facility Contacts

Xiaoming Du, PhD

Role: primary

Xiaoming.Du@uth.tmc.edu

410-402-6036

Bhim Adhikari

Role: backup

bhim.m.adhikari@uth.tmc.edu

713-486-2740

Other Identifiers

HSC-MS-23-1044 (study 2)

Identifier Type: -

Identifier Source: org_study_id