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Acoustic Neuromodulation (ANM) for Youth With Anxiety Disorders

2015-10-13 11:08:22 | BioPortfolio

Summary

The acoustic neuromodulation trial (ANM-T) is a two-phase, single-site, pilot randomized clinical trial examining the feasibility of completing a larger scale efficacy study of a novel treatment of non-linear modulated acoustic stimuli to reduce anxiety severity in youth with anxiety disorders. The primary objective is to establish the feasibility of a blinded randomized controlled trial of ANM for childhood anxiety disorders.

Description

The acoustic neuromodulation trial (ANM-T) is a two-phase, single-site, pilot randomized clinical trial examining the feasibility of completing a larger scale efficacy study of a novel treatment of non-linear modulated acoustic stimuli to reduce anxiety severity in youth with anxiety disorders. Phase I involves a randomized controlled trial comparing active acoustic neuromodulation to a non-active acoustic stimuli (Placebo or PBO) in youth ages 7-17 years with at least one of the following primary DSM-5 diagnoses: separation anxiety disorder (SAD), social anxiety disorder and generalized anxiety disorder (GAD).

Additionally, this study will include up to ten healthy volunteer participants in order for study staff to be appropriately trained to administer the EEG. Furthermore, three pilot cases will be completed at the start of data collection to ensure effective delivery of all study procedures and maintenance of blind during the acute study phase. Phase II is a 3-month treatment maintenance period for Phase I responders. Phase I non-responders to PBO will be offered active open treatment. Assessments will include those that will likely be used in a larger efficacy trial including parent on child report, and child self report, and blinded independent evaluator ratings of the primary outcomes. In addition, in an effort to assess over all feasibility, monthly recruitment rate, number of consents signed, subjects randomized, rate of adherence to the treatment protocol, safety of the intervention and control conditions, patient and family acceptability of the treatment and assessment protocols will be evaluated. Study Phases Entry Gates: 30 subjects ages 7-17 years will be enrolled, using a multiple gating procedure designed to ensure that subjects enrolled evidence a stable, pervasive anxiety diagnosis at the start of treatment.

- Gate A is a 20-minute semi-scripted telephone screening procedure to elicit preliminary inclusion/exclusion information and to provide additional information to the caller.

- Gate B is a screening assessment that determines "caseness".

After completing informed consent participants and their parents will complete standard questionnaires and will be interviewed to establish that the child meets all inclusion and no exclusion criteria and are medically safe to complete the study (clearance from the pediatrician and pregnancy test for menstruating females). This visit will be videotaped and will last approximately 2.5 hours.

-Gate C is a baseline assessment of anxiety severity and randomization visit and takes approximately 2.5 hours and will be videotaped. All subjects will be recruited and screened and enrolled by investigators at the Weill Cornell Medical College.

Phase I: Phase I is a 6-week randomized (1:1) controlled comparison of ANM and PBO. Subjects will come in for 20-minute treatment sessions approximately every other day for 2 weeks (5 days in 2 weeks). At each study treatment visit the study coordinator will collect a brief interim history of anxiety symptoms and adverse events prior to treatment. Formal outcome assessment by the blind independent evaluator (IE) will be collected at week 6.

Phase II: Phase II is a 17 week treatment maintenance phase (from week 7 to 24). At this stage, ALL PARTICIPANTS will begin active treatment. Active responders from phase 1 will be monitored for the durability of the treatment response. Non-responders to the active treatments will be given a second chance to elicit a response. Non-responders to control treatment will have a full course of the active treatment. Control treatment responders will be given the chance to respond to active treatment. At each study visit the coordinator will collect an interim history and adverse events. Formal outcome assessment by a blind independent evaluator will occur at weeks 12 and 24

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Conditions

Separation Anxiety Disorder

Intervention

Acoustic Neuromodulation (ANM)

Location

Weill Cornell Medical College
New York
New York
United States
10065

Status

Recruiting

Source

Weill Medical College of Cornell University

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-10-13T11:08:22-0400

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