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

NCT02344784 | Unknown

• 2 other identifiers: HaEmekMC0071-14
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Attention Deficit Disorder

Keywords

ADD; ADHD; PPI

Outcome Measures

Primary Outcomes (1)

• Electromyography (EMG) of the right and the left Orbicularis oculi muscle will be recorded during the Prepulse inhibition test

  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 (1)

• Galvanic skin response will be measured by conductivity (Mv) units during the Prepulse inhibition test

  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

Interventions

SR-HLAB EMG DEVICE

Prepulse inhibition test using SR-HLAB EMG device will record the acoustic startle response for each participant: with and without Methylphenidate treatment

Methylphenidate DRUG

The regular daily dose of P.O methylphenidate of each participant will be given directly after the first prepulse inhibition test

Also known as: Ritalin

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• Between the ages of 7-18
• Diagnosed with attention deficit hyperactivity disorder according to Diagnostic and statistical manual of mental disorders, fifth edition- Clinical diagnostic interview was performed.
• Receive drug therapy with methylphenidate doses ranging from 0.3 mg / kg to 1 mg / kg.
• The participant is treated with methylphenidate at least two months prior to the experiment.

You may not qualify if:

• Autism.
• Chronic neurological diseases.
• Developmental delay.
• Psychotic or major effective disorder (psychotic state now or in the past, schizophrenia, schizoaffective, depression, bipolar disorder)
• Substance abuse.
• Mental retardation.
• Contraindicated for the treatment of methylphenidate.
• Hearing problems.
• Pregnancy week 20 and thereafter

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead
• Technion, Israel Institute of Technology: collaborator

Study Sites (1)

The mental health clinic for children and adolescents at the HaEmek Medical Center

Afula, 18101, Israel

Location

Related Publications (24)

• Pastor PN, Reuben CA. Diagnosed attention deficit hyperactivity disorder and learning disability: United States, 2004-2006. Vital Health Stat 10. 2008 Jul;(237):1-14.

  PMID: 18998276 BACKGROUND

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• Biederman J, Quinn D, Weiss M, Markabi S, Weidenman M, Edson K, Karlsson G, Pohlmann H, Wigal S. Efficacy and safety of Ritalin LA, a new, once daily, extended-release dosage form of methylphenidate, in children with attention deficit hyperactivity disorder. Paediatr Drugs. 2003;5(12):833-41. doi: 10.2165/00148581-200305120-00006.

  PMID: 14658924 BACKGROUND

• Ornitz EM, Hanna GL, de Traversay J. Prestimulation-induced startle modulation in attention-deficit hyperactivity disorder and nocturnal enuresis. Psychophysiology. 1992 Jul;29(4):437-51. doi: 10.1111/j.1469-8986.1992.tb01717.x.

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• Castellanos FX, Fine EJ, Kaysen D, Marsh WL, Rapoport JL, Hallett M. Sensorimotor gating in boys with Tourette's syndrome and ADHD: preliminary results. Biol Psychiatry. 1996 Jan 1;39(1):33-41. doi: 10.1016/0006-3223(95)00101-8.

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• Ornitz EM, Russell AT, Hanna GL, Gabikian P, Gehricke JG, Song D, Guthrie D. Prepulse inhibition of startle and the neurobiology of primary nocturnal enuresis. Biol Psychiatry. 1999 Jun 1;45(11):1455-66. doi: 10.1016/s0006-3223(98)00205-4.

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• Braff DL, Geyer MA, Swerdlow NR. Human studies of prepulse inhibition of startle: normal subjects, patient groups, and pharmacological studies. Psychopharmacology (Berl). 2001 Jul;156(2-3):234-58. doi: 10.1007/s002130100810.

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• Hawk LW Jr, Yartz AR, Pelham WE Jr, Lock TM. The effects of methylphenidate on prepulse inhibition during attended and ignored prestimuli among boys with attention-deficit hyperactivity disorder. Psychopharmacology (Berl). 2003 Jan;165(2):118-27. doi: 10.1007/s00213-002-1235-7. Epub 2002 Nov 1.

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• Ashare RL, Hawk LW Jr, Shiels K, Rhodes JD, Pelham WE Jr, Waxmonsky JG. Methylphenidate enhances prepulse inhibition during processing of task-relevant stimuli in attention-deficit/hyperactivity disorder. Psychophysiology. 2010 Sep;47(5):838-45. doi: 10.1111/j.1469-8986.2010.01001.x. Epub 2010 Mar 10.

  PMID: 20233343 BACKGROUND

• Takahashi H, Hashimoto R, Iwase M, Ishii R, Kamio Y, Takeda M. Prepulse inhibition of startle response: recent advances in human studies of psychiatric disease. Clin Psychopharmacol Neurosci. 2011 Dec;9(3):102-10. doi: 10.9758/cpn.2011.9.3.102. Epub 2011 Dec 31.

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• Schulz-Juergensen S, Thiemann A, Gebhardt J, Baumgarten-Walczak A, Eggert P. Prepulse inhibition of acoustic startle and the influence of methylphenidate in children with ADHD. J Atten Disord. 2014 Feb;18(2):117-22. doi: 10.1177/1087054712448960. Epub 2012 Jun 19.

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MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• AVRAHAM AVITAL

  Technion, Israel Institute of Technology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 16, 2015
• First Posted: January 26, 2015
• Study Start: January 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 23, 2016

Record last verified: 2016-08

Locations

IL (1)