Overview

This trial is active, not recruiting.

Condition attention deficit disorder
Treatments sr-hlab emg, methylphenidate
Sponsor HaEmek Medical Center, Israel
Collaborator Technion, Israel Institute of Technology
Start date January 2015
End date March 2017
Trial size 46 participants
Trial identifier NCT02344784, 0071-14, HaEmekMC

Summary

The purpose of this study is to show that Prepulse inhibition test of acoustic startle response is an indicator of objective diagnostic characteristics of attention deficit disorder in children and adolescents.

by demonstrating that Prepulse inhibition test of acoustic startle response is impaired in children and adolescents suffering from attention deficit disorder in the relation to the normal function described in the literature.

The investigators will try to prove our hypothesis by an experiment that consists of two phases:

Phase I (about 25 minutes):

The patient will enter the room, will be asked to sit on a chair, and will be asked to look at a computer screen showing silent video of aquarium fish, then the patient will be connected to both the Prepulse inhibition test device and the Galvanic skin response device and pass the tests.

Phase II (about 25 minutes):

After completion of Phase I, each participant will receive his daily regular dose of methylphenidate and after an hour and a half from taking the drug, will repeat the tests, both the Prepulse inhibition test and the Galvanic skin response test.

Duration of the entire experiment is 140 minutes (two hours and twenty minutes).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective cross-sectional

Primary Outcomes

Measure
Electromyography (EMG) of the right and the left Orbicularis oculi muscle will be recorded during the Prepulse inhibition test
time frame: The outcome measure will be assessed imediatly during each test and the participants will be followed for the whole duration of the experiment, an expected average of 3 hours

Secondary Outcomes

Measure
Galvanic skin response will be measured by conductivity (Mv) units during the Prepulse inhibition test
time frame: The outcome measure will be assessed imediatly during each test and the participants will be followed for the whole duration of the experiment, an expected average of 3 hours

Eligibility Criteria

Male or female participants from 7 years up to 18 years old.

Inclusion Criteria: 1. Between the ages of 7-18 2. Diagnosed with attention deficit hyperactivity disorder according to Diagnostic and statistical manual of mental disorders, fifth edition- Clinical diagnostic interview was performed. 3. Receive drug therapy with methylphenidate doses ranging from 0.3 mg / kg to 1 mg / kg. 4. The participant is treated with methylphenidate at least two months prior to the experiment. Exclusion Criteria: 1. Autism. 2. Chronic neurological diseases. 3. Developmental delay. 4. Psychotic or major effective disorder (psychotic state now or in the past, schizophrenia, schizoaffective, depression, bipolar disorder) 5. Substance abuse. 6. Mental retardation. 7. Contraindicated for the treatment of methylphenidate. 8. Hearing problems. 9. Pregnancy week 20 and thereafter

Additional Information

Official title The Characteristics of Prepulse Inhibition in Children and Adolescents Suffering From Attention Deficit Disorder: With and Without Medication.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by HaEmek Medical Center, Israel.