The Characteristics of Prepulse Inhibition in Children and Adolescents Suffering From Attention Deficit Disorder (PPI)

August 22, 2016 updated by: ESSAM DAOD, HaEmek Medical Center, Israel

The Characteristics of Prepulse Inhibition in Children and Adolescents Suffering From Attention Deficit Disorder: With and Without Medication.

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 18101
        • The mental health clinic for children and adolescents at the HaEmek Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Children and adolescents (age 7 to 17.11 years) who are diagnosed with attention deficit hyperactivity disorder and are under the Medical surveillance of the mental health clinic for children and adolescents at the HaEmek Medical Center- Afula.

Patients who meet the criteria for inclusion and exclusion will be offered to participate in the study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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 Outcome Measures

Outcome Measure
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Collaborators

Technion, Israel Institute of Technology

Investigators

  • Study Chair: AVRAHAM AVITAL, Technion, Israel Institute of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

June 1, 2017

Study Registration Dates

First Submitted

January 16, 2015

First Submitted That Met QC Criteria

January 22, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Estimate)

August 23, 2016

Last Update Submitted That Met QC Criteria

August 22, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HaEmekMC
  • 0071-14 (Other Identifier: HaEmekMC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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