Impact of Cerebellar TMS on Brain and Cognitive Functions in Schizophrenia: a Pilot Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorNorthwell Health
About this trial
This is a single-site, sham-controlled, randomized trial in a total of 40 subjects between ages 18 and 60 years with schizophrenia. This study will investigate the effects of 4-week rTMS treatment on brain and cognitive functions in patients. Subjects will be randomized to one of the following arms:
Arm 1: Standard of Care (SOC) and active rTMS Arm 2: Standard of Care (SOC) and sham rTMS
Each participant will receive rTMS five days per week, for four consecutive weeks. Functional magnetic resonance imaging (fMRI) scans, clinical assessments, and cognitive tests will be performed at baseline, end of the 2nd week, and end of the 4th week.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Male or female subjects 18 to 60 years of age
DSM-V diagnosis of schizophrenia spectrum disorders
Competent to provide informed consent
Disqualifiers
Lifetime DSM-V diagnosis of an Axis-I disorder other than schizophrenia spectrum disorders
Lifetime diagnosis of ataxia or other cerebellar disorders
Lifetime diagnosis of mental retardation, dementia, Alzheimer's disease, Parkinson's disease, Huntington's disease, or other neurodegenerative disorders
Any active general medical condition or CNS disease which can affect cognition or response to treatment
Trial design
Design model
Factorial
Treatments tested in this trial
Transcranial Magnetic Stimulation
DeviceThe TMS will be administrated using the MagVenture Mag Pro R30 device equipped with a B-70 coil. The FDA-approved iTBS sequence will be applied: 10 bursts of three biphasic pulses at 50 Hz, repeated at 5 Hz, for 10 seconds for a total of 600 pulses, and will be repeated for three times. The total stimulation time is \~10 min per session (day). Patients will receive five sessions (days) of rTMS each week, and the total treatment will last for four weeks.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: TMSExperimental treatment 1 intervention
Group B: ShamSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Cerebellar function
Changes of cerebellar connectivity after TMS treatment compared with baseline, as measured by functional magnetic resonance imaging (fMRI)
Time frame
end of 2nd week and 4th weekSecondary outcomes
1
Cognitive function
Changes of scores for the Brief Assessment of Cognition in Schizophrenia (BACS) battery after TMS treatment compared with baseline
Time frame
end of 2nd week and 4th weekOther outcomes
1
Cerebellum-cognition associations
Pearson Correlations between changes of cerebellar connectivity (as measured by fMRI) and changes of cognitive scores (as measured by BACS)
Time frame
end of 2nd week and 4th weekSponsors and contacts
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Source ClinicalTrials.gov