The University of Texas Health Science Center, Houston
Houston, Texas, 77054, United States
Location status: Recruiting
Location contact
Bhim Adhikari
CONTACT
Xiaoming Du, PhD
CONTACT
NCT Number: NCT06961916
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Not applicable
Houston, Texas, 77054, United States
Location status: Recruiting
Bhim Adhikari
CONTACT
Xiaoming Du, PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
For the cognitive training sessions, patients will be asked to play cognitive computer games involving processing speed tasks for about 15 to 30 minutes.
Time frame: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Total score will be reported and ranges from 0 to 21, with a higher score indicating greater delusion.
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,
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
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: baseline, visit 6 (about 1 week after baseline), visit 10 (about 2 weeks after baseline)
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)
Total score will be reported and ranges from 0 to 32, with a higher score indicating greater cognitive function.
Contact information is provided by the study sponsor or research team.
Bhim M Adhikari
CONTACT
Xiaoming Du, PhD
CONTACT
The University of Texas Health Science Center, Houston
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07045142
Dyslipidemias, Lipid Metabolism Disorders
Zhumadian, Henan, China
View Trial DetailsNCT07369154
Mental Disorders, Schizophrenia
Chandler, Arizona, United States
View Trial DetailsNCT07411222
Behavior, Bipolar Disorder
Bolu, Turkey (Türkiye)
View Trial DetailsNCT06882785
Mental Disorders, Schizophrenia
Kōnan, Aichi-ken, Japan
View Trial Details