This is a clinical research trial exploring the efficacy of non-invasive neuromodulation (NM) intervention in the treatment of anxiety. The NM used in this study consists of 25 minutes of 5 hz transcranial alternating current stimulation (tACS) titrated up to 2mA targeting the anterolateral amygdala across 12 treatment sessions with a 3-4 week time period. The studied population includes patients with the following anxiety disorders: generalized anxiety disorder (GAD), social anxiety disorder (SAD), separation anxiety disorder of childhood, and post-traumatic stress disorder (PTSD). Participants will be randomly assigned to tACS or sham, cross-over, then followed by an optional open-label extension phase.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
40
2mA tACS over right hemisphere, at positions F4, P4, T8 (10-10 convention)
NCI Clinical Research Foundation
Mount Arlington, New Jersey, United States
RECRUITINGResponse rate informed by Beck Anxiety Inventory (BAI)
BAI is a self-rated scale, with scores ranging from 0 to 63. We will calculate the treatment response rate as (pre-treatment BAI minus post-treatment BAI)/pre-treatment BAI
Time frame: 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks.
Hamilton Anxiety Rating Scale (HAMA)
HAMA is a clinician-rated scale, with scores ranging from 0 to 56. We will calculate the treatment response rate as (pre-treatment HAMA minus post-treatment HAMA)/pre-treatment HAMA. We will compute the average of response rates from HAMA and BAI as the final outcome measure.
Time frame: 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks.
PTSD Checklist (PCL) for PTSD cohort
For the PTSD patients, in addition to anxiety measurement, we will also use PCL (ranges from 0 to 80) to register the symptom severity change. Again, the outcome measure is the treatment response rate, defined as pre-treatment PCL minus post-treatment PCL)/pre-treatment PCL
Time frame: 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks.
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