Enhancing Brain Connectivity in Schizophrenia Through Neuromodulation (Study 2)

NCT06961916 | Recruiting DMC FDA Device

• 1 other identifier: HSC-MS-23-1044 (study 2)
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Schizophrenia

Keywords

Transcranial magnetic stimulation; schizophrenia; white matter; connectivity; myelination

Outcome Measures

Primary Outcomes (2)

• Brain microstructural integrity as indicated by white matter fractional anisotropy (FA) values as assessed by magnetic resonance imaging (MRI)

  Fractional anisotropy (FA) values will be reported. FA values range from 0 to 1 with larger values indicating greater white matter integrity.

  baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)

• Brain connectivity as indicated by resting-state functional connectivity (rsFC) values as assessed by functional MRI (fMRI)

  rsFC values will be reported as a Z-score with a range of -1 to 1, with greater absolute values indicating stronger brain connectivity.

  baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)

Secondary Outcomes (14)

• Electrophysiological response as indicated by mismatch negativity as assessed by electroencephalography (EEG)

  baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)

• Electrophysiological response as indicated by steady-state auditory evoked responses from electroencephalography recording (EEG)

  baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)

• Cognitive insight as assessed by the Beck Cognitive Insight Scale

  baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)

• Depression as assessed by the Depression State and Trait Scale (DST) - state

  baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)

• Depression as assessed by the Depression State and Trait Scale (DST) - trait

  baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)

Study Arms (1)

Active rTMS combined with Cognitive Training

EXPERIMENTAL

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.

Device: Active rTMS; Behavioral: Cognitive Training

Interventions

Active rTMS 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.

Active rTMS combined with Cognitive Training

Cognitive Training 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.

Active rTMS combined with Cognitive Training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

The University of Texas Health Science Center, Houston

Houston, Texas, 77054, United States

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Xiaoming Du, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bhim M Adhikari

CONTACT

713-486-2740; bhim.m.adhikari@uth.tmc.edu

Xiaoming Du, PhD

CONTACT

443-882-9717; Xiaoming.Du@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 8, 2025
• Study Start: June 3, 2025
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): May 1, 2029
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)