This study is to determine the tolerability and efficacy of an accelerated schedule of Transcranial Magnetic Stimulation for treating symptoms of psychotic disorders such as schizophrenia.
The aim of this protocol is to test the hypothesis that 'accelerated' Transcranial Magnetic Stimulation (TMS) is safe and efficacious in the treatment of psychotic disorders. TMS is a neuromodulation technique that utilizes magnets to alter neuronal activity non-invasively. TMS has received FDA approval as a therapeutic intervention for multiple psychiatric disorders. Historically, these FDA approved treatments have consisted of daily sessions spread out over multiple weeks. "Accelerated" TMS protocols deliver multiple TMS sessions daily over a shorter time frame (e.g., one week). Evidence from dozens of studies across multiple disorders suggests that these protocols are safe and effective. In this protocol we will test the hypothesis that a form of TMS previously used to treat symptoms of schizophrenia is safe and effective when delivered on an accelerated schedule. Participants in this trial will receive neuronavigated intermittent theta burst TMS targeted to personalized network targets on an accelerated schedule. Our primary outcomes will be to determine if delivering TMS on this schedule is as safe and easily tolerated as it is in other disorders. Additional outcomes measured will be to test the impact of accelerated TMS on multiple clinical and cognitive measures as well as neuroimaging markers of symptom response.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
rTMS is a technique of TMS that allows the selective external manipulation of neural activity in a non-invasive manner. During TMS, a rapidly changing current is passed through an insulated coil placed against the scalp. This generates a temporary magnetic field that in turn induces electrical current in neurons and allows the modulation of neural circuitry. The combination of TMS with functional MRI allows the selective targeting and modulation of brain networks. The repeated application of rTMS can cause long term changes in behavior and task performance that is reflected in altered brain network connectivity. The pattern of rTMS will consist of intermittent Theta Burst Stimulation (iTBS) pattern consisting of 2 s trains of 3 pulses at 50 Hz, repeated at 5 Hz, every 10s for a total of 600 pulses per session. Sessions will be separated by an interval of 50 minutes (up to a total of 8 per day).
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Tolerability of accelerated TMS
Participants will be monitored for routinely surveyed on their experience of side effects of TMS. These include both common effects such as headache or neck pain as well as rarer side effects such as dizziness.
Time frame: 5 days of multiple session of TMS per day
Change in cerebellar-cerebral resting-state functional connectivity
Participants will receive a MRI before TMS and after TMS. Resting-state functional MRI data will be collected. Symptom change will be correlated with resting-state functional MRI connectivity change between pre- and post-TMS MRI scans
Time frame: Before treatment (Baseline) and 1 week and 3 weeks post treatment
Change in severity of negative symptoms of schizophrenia
The Positive and Negative Symptoms Scale (PANSS) is a 30-item rating instrument evaluating the presence/absence and severity of positive, negative and general psychopathology of schizophrenia. The scale was developed from the Brief Psychiatric Rating Scale (BPRS) and the Psychopathology Rating Scale. All 30 items are rated on a 7-point scale (1=absent; 7=extreme).
Time frame: Before treatment (Baseline) and 1 week and 3 weeks and 24 weeks post treatment
Change in auditory hallucination severity
The Psychotic Symptom Rating Scale, AH subscale (PSYRATS-AH) is an interviewer rated scale to assess auditory hallucination (AH) severity and phenomenology. It measures AH frequency, duration, location, loudness, beliefs regarding origin of voices, amount and degree of negative content of voices, amount and intensity of distress associated with voices, disruption to life caused by voices, and controllability of voices.
Time frame: Before treatment (Baseline) and 1 week and 3 weeks and 24 weeks post treatment
Change in information processing speed
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The Measurement And Treatment Research to Improve Cognition in Schizophrenia Consensus Cognitive Battery (MCCB) is used to provide a relatively brief evaluation of key cognitive domains relevant to schizophrenia and related disorders. It is used as a measure of cognitive change in repeated testing applications.
Time frame: Before treatment (Baseline) and 1 week and 3 weeks and 24 weeks post treatment