An interventional study of Acoustic Neuromodulation (ANM) in Separation Anxiety Disorder, Generalized Anxiety Disorder and Social Phobia, sponsored by Weill Medical College of Cornell University. Terminated at 1 site in United States. Open to participants aged 7 Years to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-01-14.
Sponsored by Weill Medical College of Cornell University · Not applicable, Interventional, and Treatment
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.
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.
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
59 studies on the registry are indexed under Anxiety, Separation; 5 are open to participants now.
This study's enrollment of 6 is below the median of 68 across 53 interventional studies indexed under Anxiety, Separation.
Browse Anxiety, Separation studies →Weill Medical College of Cornell University is the lead sponsor of 892 studies on the registry; 165 are open to participants now.
Of its 123 completed or terminated interventional studies of FDA-regulated products, 94 (76%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
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.
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.
Time frame: 12 weeks. The ADIS will be measured at Wk 0, Wk 6, and Wk 12.
Electroencephalogram (EEG)
The EEG uses original software to calculate spectral density of bioelectrical brain activity in different frequency ranges, and power of heart pulse spectrum in low frequency and high frequency ranges, in order to characterize the vagal-sympathetic balance of a given subject. The EEG is administered to monitor changes over course of treatment.
Time frame: 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.
Plan to share: No
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This study is terminated, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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