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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active group | Experimental |
| |
| Sham group | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transcranial alternating current stimulation (tACS) | Device | 2mA tACS over right hemisphere, at positions F4, P4, T8 (10-10 convention) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Response 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 | 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. | 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 treatment sessions, with 3-4 sessions/week, and the time frame for each participant is 3 to 4 weeks. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerald Tramontano, PhD | Contact | 9736010100 | gtramontano@neuroci.com |
| Name | Affiliation | Role |
|---|---|---|
| Gerald Tramontano | NCI Clinical Research Foundation | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NCI Clinical Research Foundation | Recruiting | Mount Arlington | New Jersey | 07856 | United States |
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D065908 | Transcranial Direct Current Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D003295 | Convulsive Therapy |
| D013000 | Psychiatric Somatic Therapies |
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| D004191 | Behavioral Disciplines and Activities |
| D004597 | Electroshock |
| D011580 | Psychological Techniques |