TMS Related Biomarker Assessments

NCT05660018 | Completed Results DMC FDA Device

• 1 other identifier: HP-00103592
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with schizophrenia spectrum disorder (SSD) will be exposed to active and sham repetitive transcranial magnetic stimulation (rTMS) in separate sessions. SSD-related biomarkers will be assessed before and after the rTMS administration.

Conditions

Schizophrenia; Schizophrenia Schizoaffective

Keywords

schizophrenia; Transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (2)

• Change of Resting-state Functional Connectivity (rsFC) by Active and Sham rTMS

  The strength of rsFC was first defined by correlation coefficient (r). Because the distribution of r values is highly skewed, z scores (normally distributed) were computed via fisher r-to-z transform. The z score central value (i.e., z score of 0) represents no relationship between the two brain regions. A positive (negative) z score indicates a positive (negative) association between the two brain regions. Stronger rsFC (i.e., larger positive z score) was related to stronger connection between the two brain regions. The differences of rsFC between active and sham were reported. A positive (negative) value of rsFC change suggests the rsFC was enhanced (weakened) by active TMS.

  2 weeks

• Change of Mismatch Negativity (MMN) From Electroencephalography (EEG) Signals by Active and Sham rTMS

  TMS effect is explored by comparing MMN changes from active and sham rTMS. MMN is measured by subtracting the averaged EEG response to a set of standard stimuli from the averaged response to rarer deviant stimuli, and taking the amplitude of this difference wave in a given time window. The differences of MMN between active and sham were reported. A negative (positive) value of rsFC change suggests the MMN was enhanced (weakened) by active TMS.

  2 weeks

Study Arms (2)

Active rTMS first and sham rTMS second

OTHER

Participants in this arm will receive active rTMS in one visit first, then receive sham rTMS in another visit.

Device: active rTMS first, then sham rTMS

Sham rTMS first and active rTMS second

OTHER

Participants in this arm will receive sham rTMS in one visit first, then receive active rTMS in another visit.

Device: sham rTMS first, then active rTMS

Interventions

sham rTMS first, then active rTMS DEVICE

Sham rTMS is delivered on the first visit, then active rTMS is delivered on the second visit.

Sham rTMS first and active rTMS second

active rTMS first, then sham rTMS DEVICE

Active rTMS is delivered on the first visit, then sham rTMS is delivered on the second visit.

Active rTMS first and sham rTMS second

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and Female between ages 18-65
• Ability to give written informed consent (age 18 or above)
• Diagnosed with schizophrenia-spectrum disorder and Evaluation to Sign Consent (ESC) above10.

You may not qualify if:

• Any history of seizures.
• Significant alcohol or other drug use (substance dependence within 6 months or substance abuse within 1 month) other than nicotine or marijuana dependence.
• Any major medical illnesses that may affect normal brain functioning. Examples of these conditions include, but not limited to, stroke, CNS infection or tumor, other significant brain neurological conditions.
• Taking \> 400 mg clozapine/day
• Failed TMS screening questionnaire
• Cardiac pacemakers, implanted medication pumps, intracardiac lines, or acute, unstable cardiac disease, with intracranial implants (e.g. aneurysm clips, shunts, stimulators, cochlear implants, or electrodes) or any other metal object within or near the head, excluding the mouth, that cannot be safely removed.
• History of head injury with loss of consciousness over 10 minutes; history of brain surgery
• Can not refrain from using alcohol and/or marijuana 24 hours or more \& cigarette smoking half and hour or more prior to experiments.
• Woman who is pregnant (child-bearing potential but not on contraceptive and missing menstrual period; or by self report; or by positive pregnancy test) or has had unprotected sexual intercourse without birth control in the last 4 weeks.

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21228, United States

Location

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Xiaoming Du
• Organization: UTHealth Houston

Xiaoming.Du@uth.tmc.edu

4438829717

Study Officials

• Xiaoming Du, PhD

  University of Maryland, Baltimore

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 2, 2022
• First Posted: December 21, 2022
• Study Start: January 7, 2023
• Primary Completion: February 14, 2025
• Study Completion: February 14, 2025
• Last Updated: January 9, 2026
• Results First Posted: January 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)