Acoustic Neuromodulation (ANM) for Youth With Anxiety Disorders

NCT02572973 | Terminated

• 1 other identifier: 1403014928
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Separation Anxiety Disorder; Generalized Anxiety Disorder; Social Phobia

Outcome Measures

Primary Outcomes (1)

• Anxiety Disorders Interview Schedule (ADIS)

  The ADIS will be measured to to establish the efficacy of ANM to placebo in reducing anxiety symptoms and associated disability.

  12 weeks. The ADIS will be measured at Wk 0, Wk 6, and Wk 12.

Secondary Outcomes (1)

• Electroencephalogram (EEG)

  12 Weeks. EEGs will be administered at Wk 0, Wk 1, Wk 2, Wk 4, Wk 6, Wk 7, Wk 8, Wk 10 and and Wk 12.

Study Arms (2)

Active Treatment

ACTIVE COMPARATOR

The Acoustic Neuromodulation (ANM) active treatment intervention is a non-invasive form of therapy in which certain sounds at certain intervals are delivered to a subject through headphones five times over the course of two weeks. The sounds are delivered for 12 minutes at each session. The level of sound during Sound Stimuli (SS) presentation is relatively low (20-40 decibels), and the volume level can be adjusted downward if the subject requests it. The active intervention sounds used in the trial couple sequential frequencies to the base frequency in a nonlinear (exponential) manner following a special algorithm developed by Dr. Izvarina. This algorithm varies both the rate of change and duration of the overlaying modulation that is presented to the brain.

Other: Acoustic Neuromodulation (ANM)

Non-Active Placebo

PLACEBO COMPARATOR

The Acoustic Neuromodulation (ANM) treatment intervention is a non-invasive form of therapy in which certain sounds at certain intervals are delivered to a subject through headphones five times over the course of two weeks. The sounds are delivered for 12 minutes at each session. The placebo sounds used in this trial mimic the active sounds, but instead of using nonlinear modulation, they are coupled to the base frequency in a linear manner. Both the sequence used as well as the rate of change and duration of this overlaying modulation are the same as that used for the active sounds. The only difference is use of a linear algorithm for the placebo sounds and a nonlinear (exponential) algorithm for the active sounds.

Other: Acoustic Neuromodulation (ANM)

Interventions

Acoustic Neuromodulation (ANM) OTHER

The purpose of this study is test the safety of the Acoustic Neuromodulation (ANM) treatment and see what effects it has on your child's anxiety symptoms. Observation and anecdotal evidence suggest that this is an effective intervention for anxiety disorders. This is the first research study to test this theory, and could lead to more robust studies in the future. This study intends to assess the efficacy of this type of intervention for children with an anxiety disorder. As this is only a pilot study, the results will also inform the design and execution of future research on this treatment. We hope to add to the growing literature supporting novel treatment approaches for affected individuals.

Active Treatment; Non-Active Placebo

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Ages 7-17 years inclusively (i.e., must be at least 7 years) at the point of consent
• Primary DSM 5 diagnosis of SepAD, SocAD, or GAD on the ADIS-RLV (Gate B).
• Anxiety severity of moderate or greater (CGI-S \>3 and functional impairment (CGAS score of \<60) (Gate C).

You may not qualify if:

• Estimated child Full Scale IQ \< 80, as measured by the vocabulary and block design subtests of the WISC-III) (Gate B). If a potential subject has a verified IQ score in the three years prior to enrollment as measured by the WISC-III, IIIR, K-ABC, or Stanford-Binet no IQ assessment is required.
• Child meets criteria for current primary or co-primary Panic Disorder, OCD, PTSD, conduct disorder or substance abuse (Gate B).
• Child meets criteria for Major Depressive Disorder at greater severity than anxiety disorder (Gate B). d. Subjects with the following lifetime psychiatric disorders will be excluded: bipolar disorder, PDD (Asperger's, autism), MDD with psychosis, schizophrenia, and schizoaffective disorder (Gate B).
• Current use of psychotropic medication or clinical indication for use of psychotropic medication (except for youth entering on a stable psychostimulant regimen for ADHD) (Gates A, B).
• Recent treatment with psychotropic medication within 6 weeks of study entry for fluoxetine, within 2 weeks for other SSRIs, and within 4 weeks for neuroleptics (Gates A, B).
• Child has failed an adequate trial of CBT for anxiety within the previous 2 years (at least 10 treatment sessions over a period of less than 1 year conducted by a licensed provider of CBT) (Gates A, B).
• Child has a major neurological disorder, a major medical illness or hearing impairment that requires a prohibited episodic or chronic systemic medication or that would interfere with participation in the study (e.g., frequent hospitalizations, frequent school absences) (Gates A, B).
• Child is pregnant as indicated by history or a positive pregnancy test at Gate B. Sexually active girls must agree to use an effective form of birth control, either hormonal (BCP, Depo-Provera or Norplant), spermicide (foam or vaginal suppository) or a barrier method (condoms, diaphragm, cervical cap) or a combination of barrier/spermicide contraception in order to participate in the study.
• Child poses a significant risk for dangerousness to self or to others (Gates A, B, C).
• Child or parent is non-English speaking (unable to complete measures, IE ratings or treatment without the assistance of a translator) (Gates A, B). NYSPI and UCLA may recruit Spanish speaking subjects.
• Child is a victim of ongoing or previously undisclosed child abuse requiring new department of social service report or ongoing department of social service supervision (Gate B).
• Child has a history of seizures

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• The Hartwell Foundation: collaborator

Study Sites (1)

Weill Cornell Medical College

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Anxiety, Separation; Generalized Anxiety Disorder; Phobia, Social

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders; Neurodevelopmental Disorders; Phobic Disorders

Study Officials

• John Walkup, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2015
• First Posted: October 9, 2015
• Study Start: July 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: January 14, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)