This clinical trial is an investigator-initiated open label study designed to evaluate the safety and efficacy of sTMS in subjects with Generalized Anxiety Disorder.
Subjects will receive 5 daily treatments per treatment week for 4 weeks (20 treatments). Patients who do not meet a 50% reduction of Hamilton Anxiety Rating Scale (HAM-A) score (non-responders) at 4 weeks will be offered 2 additional treatment weeks for up to 30 treatments total. Subjects who qualify for enrollment will be followed and assessed using the: Mini International Neuropsychiatric Interview (MINI) for Axis 1, Montreal Cognitive Assessment (MoCA), Hamilton Anxiety Rating Scale (HAM-A), Hamilton Depression Rating Scale (HAM-D17), Generalized Anxiety Disorder 7-item (GAD-7), and Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR16) patient reported scale. Treatment will be initiated on Day 1 of the study and will be continued for a minimum of 4 and a maximum of 6 weeks.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Subjects who qualify will receive daily active sTMS treatments with the NeoSync, Inc sTMS device. The device includes an EEG recording module and the device uses a proprietary algorithm to determine the individualized alpha frequency (IAF). The IAF obtained during this baseline recording is used throughout the study. The device contains three magnets in the sagittal line above the subject's scalp, which rotate along a transverse axis. sTMS stimulation is delivered broadly over the prefrontal and frontal regions of the brain. These magnets rotate to generate a sinusoidal magnetic field set at precisely the average individualized alpha frequency (IAF). Each therapy session lasts 30 minutes.
Mean change in score on the Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Baseline to Week 4
Clinical response on the Hamilton Anxiety Rating Scale
Clinical response defined as greater than or equal to 50% reduction of assessment score
Time frame: Baseline to Week 4
Clinical response on the Generalized Anxiety Disorder 7-item scale (GAD-7)
Clinical response defined as greater than or equal to 50% reduction of assessment score
Time frame: Baseline to Week 4
Clinical response on the Hamilton Depression Rating Scale (HAM-D17)
Clinical response defined as greater than or equal to 50% reduction of assessment score
Time frame: Baseline to Week 4
Clinical response on the Quick Inventory of Depressive Symptomatology Self Report (QIDS-SR16)
Clinical response defined as greater than or equal to 50% reduction of assessment score
Time frame: Baseline to Week 4
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