NCT05660018

TMS Related Biomarker Assessments

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Maryland, Baltimore · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Electrical neural oscillations of the brain can be measured at many levels, ranging from single cell to local field potentials in animals, to large-scale synchronized activities in the human scalp. New evidence suggests that there may be common underlying abnormalities in oscillatory activities that are associated with schizophrenia-related cognitive and functional impairments. There is currently no treatment for these electrical oscillation dysfunctions. Transcranial magnetic stimulation (TMS) provides a non-invasive means for altering brain electrical neural activity. TMS has been approved by FDA for the treatment of depression and many other mental disorders. It has been used in a wide range of clinical research, especially in neurology and psychiatry. The investigators aim to develop TMS paradigms that will modulate brain responses during basic sensory to more complex cognitive performance and determine the parameters in anatomic locations and TMS modalities that may effectively and safely modulate neural activities. If the current experiments successfully identified TMS methods/paradigms that improve neural oscillation and cognitive performances in schizophrenia patients, in the future (not part of the current protocol), the investigators can then develop specific TMS treatment that may correct abnormal brain function and improve cognition and clinical symptoms of schizophrenia.

Conditions

• Schizophrenia Schizoaffective
• Schizophrenia

Interventions

Type	Name	Description
DEVICE	active rTMS first, then sham rTMS	Active rTMS is delivered on the first visit, then sham rTMS is delivered on the second visit.
DEVICE	sham rTMS first, then active rTMS	Sham rTMS is delivered on the first visit, then active rTMS is delivered on the second visit.

Timeline

• Start date: 2023-01-07
• Primary completion: 2025-02-14
• Completion: 2025-02-14
• First posted: 2022-12-21
• Last updated: 2026-01-09
• Results posted: 2026-01-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study