Patients with schizophrenia spectrum disorder (SSD) will be exposed to active repetitive transcranial magnetic stimulation (rTMS) from H coil for improving white matter integrity.
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
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
120
Multiple trains of rTMS in a day, for multiple days.
The University of Texas Health Science Center, Houston
Houston, Texas, United States
RECRUITINGBrain 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.
Time frame: 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.
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Electrophysiological response as indicated by mismatch negativity as assessed by electroencephalography (EEG)
Mismatch negativity values will be reported in microvolts (uV). Mismatch negativity is measured by subtracting the averaged response to a set of standard stimuli from the average response to deviant stimuli, and taking the amplitude of this difference in a given timepoint.
Time frame: 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)
Steady-state auditory evoked responses will be reported. The responses are measured by calculating the ratio of the power at target frequency over power at the surrounding background frequencies. The ration will be obtained in a given timepoint.
Time frame: 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
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Total score will be reported and ranges from 15 to 60, with a higher score indicating greater cognitive insight.
Time frame: 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
Total score of the state subscale of the DST will be reported and ranges from 0 to 72, with a higher score indicating greater depression state.
Time frame: 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
Total score of the trait subscale of the DST will be reported and ranges from 0 to 72, with a higher score indicating greater depression trait.
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Depression as assessed by the Calgary Depression Scale
Total score of the Calgary Depression Scale will be reported and ranges from 0 to 27, with a higher score indicating greater depression.
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Depression as assessed by the Beck Depression Inventory
Total score of the Beck Depression Inventory will be reported and ranges from 0 to 63, with a higher score indicating greater depression.
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Perception as assessed by the Perception State and Trait Scale - state
The Perception State and Trait Scale assesses alterations in the perception of audio and visual experiences. Total score ranges from 0 to 96 for the state subscale, and a higher score indicates a greater alteration of audio or visual experiences state.
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Perception as assessed by the Perception State and Trait Scale - trait
The Perception State and Trait Scale assesses alterations in the perception of audio and visual experiences. Total score ranges from 0 to 96 for the trait subscale, and a higher score indicates a greater alteration of audio or visual experiences trait.
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Delusion as assessed by the 21-item Peters Delusion Inventory (PDI-21)
Total score will be reported and ranges from 0 to 21, with a higher score indicating greater delusion.
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Emotion regulation as assessed by the Profile of Mood States (POMS)
Total score will be reported and ranges from 0 to 204, with a higher score indicating more positive emotion and mood. This outcome measure will be assessed at each of the 10 treatment visits (which are about day 1 after baseline, day 2 after baseline, day 3 after baseline, day 4 after baseline, day 5 after baseline, day 9 after baseline, day 10 after baseline, respectively).
Time frame: day 1 after baseline, day 2 after baseline, day 3 after baseline, day 4 after baseline, day 5 after baseline, day 9 after baseline, day 10 after baseline
Hallucination as assessed by the Revised Hallucinations Scale (RHS)
Total score will be reported and ranges from 0 to 13, with a higher score indicating greater hallucination. This outcome measure will be assessed at each of the 10 treatment visits (which are about day 1 after baseline, day 2 after baseline, day 3 after baseline, day 4 after baseline, day 5 after baseline, day 9 after baseline, day 10 after baseline, respectively).
Time frame: day 1 after baseline, day 2 after baseline, day 3 after baseline, day 4 after baseline, day 5 after baseline, day 9 after baseline, day 10 after baseline
Cognitive function as assessed by the Letter-Number Span subscale of the MATRICS consensus cognitive battery (MCCB)
Total score will be reported and ranges from 0 to 24, with a higher score indicating greater cognitive function.
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
Cognitive function as assessed by the Spatial Span subscale of the MATRICS consensus cognitive battery (MCCB)
Total score will be reported and ranges from 0 to 32, with a higher score indicating greater cognitive function.
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)