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

Attention Deficit Disorder Clinical Trial

— PPI  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02344784
• Other study ID #: HaEmekMC
• Secondary ID: 0071-14
• Status: Active, not recruiting
• Phase: N/A
• First received: January 16, 2015
• Last updated: August 22, 2016
• Start date: January 2015
• Est. completion date: June 2017

Study information

• Verified date: August 2016
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 46
• Est. completion date: June 2017
• Est. primary completion date: March 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 7 Years to 18 Years

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Attention Deficit Disorder
• Attention Deficit Disorder with Hyperactivity
• Disease

Intervention

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

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

Locations

Country	Name	City	State
Israel	The mental health clinic for children and adolescents at the HaEmek Medical Center	Afula

Sponsors (2)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel	Technion, Israel Institute of Technology

Country where clinical trial is conducted

Israel, 

References & Publications (24)

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. — View Citation

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. — View Citation

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. Review. — View Citation

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. — View Citation

Faraone SV, Biederman J, Mick E. The age-dependent decline of attention deficit hyperactivity disorder: a meta-analysis of follow-up studies. Psychol Med. 2006 Feb;36(2):159-65. Review. — View Citation

Feifel D, Minassian A, Perry W. Prepulse inhibition of startle in adults with ADHD. J Psychiatr Res. 2009 Jan;43(4):484-9. doi: 10.1016/j.jpsychires.2008.06.004. Epub 2008 Jul 31. — View Citation

Feldman HM, Reiff MI. Clinical practice. Attention deficit-hyperactivity disorder in children and adolescents. N Engl J Med. 2014 Feb 27;370(9):838-46. doi: 10.1056/NEJMcp1307215. Review. Erratum in: N Engl J Med. 2015 Jan 8;372(2):197. Dosage error in text. — View Citation

Gebhardt J, Schulz-Juergensen S, Eggert P. Maturation of prepulse inhibition (PPI) in childhood. Psychophysiology. 2012 Apr;49(4):484-8. doi: 10.1111/j.1469-8986.2011.01323.x. Epub 2011 Dec 16. — View Citation

Grim PF. A sustained attention comparison of children and adults using reaction time set and the GSR. J Exp Child Psychol. 1967 Mar;5(1):26-38. — View Citation

Hanlon MC, Karayanidis F, Schall U. Intact sensorimotor gating in adult attention deficit hyperactivity disorder. Int J Neuropsychopharmacol. 2009 Jun;12(5):701-7. doi: 10.1017/S1461145708009711. Epub 2008 Dec 2. — View Citation

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. Epub 2002 Nov 1. — View Citation

Holstein DH, Vollenweider FX, Geyer MA, Csomor PA, Belser N, Eich D. Sensory and sensorimotor gating in adult attention-deficit/hyperactivity disorder (ADHD). Psychiatry Res. 2013 Jan 30;205(1-2):117-26. doi: 10.1016/j.psychres.2012.08.013. Epub 2012 Sep 25. — View Citation

Kohl S, Heekeren K, Klosterkötter J, Kuhn J. Prepulse inhibition in psychiatric disorders--apart from schizophrenia. J Psychiatr Res. 2013 Apr;47(4):445-52. doi: 10.1016/j.jpsychires.2012.11.018. Epub 2013 Jan 1. Review. — View Citation

Kumari V, Fannon D, Geyer MA, Premkumar P, Antonova E, Simmons A, Kuipers E. Cortical grey matter volume and sensorimotor gating in schizophrenia. Cortex. 2008 Oct;44(9):1206-14. doi: 10.1016/j.cortex.2007.11.007. Epub 2008 Jan 20. — View Citation

Larson K, Russ SA, Kahn RS, Halfon N. Patterns of comorbidity, functioning, and service use for US children with ADHD, 2007. Pediatrics. 2011 Mar;127(3):462-70. doi: 10.1542/peds.2010-0165. Epub 2011 Feb 7. — View Citation

Molina V, Montes C, Tamayo P, Villa R, Osuna MI, Pérez J, Sancho C, López-Albuquerque T, Cardoso A, Castellano O, López DE. Correlation between prepulse inhibition and cortical perfusion during an attentional test in schizophrenia. A pilot study. Prog Neuropsychopharmacol Biol Psychiatry. 2009 Feb 1;33(1):53-61. doi: 10.1016/j.pnpbp.2008.10.011. Epub 2008 Oct 30. — View Citation

Okkesim S, Kara S, Kaya MG, Asyali MH. Analysis of coronary angiography related psychophysiological responses. Biomed Eng Online. 2011 Aug 11;10:71. doi: 10.1186/1475-925X-10-71. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Sable JJ, Kyle MR, Knopf KL, Schully LT, Brooks MM, Parry KH, Diamond RE, Flink LA, Stowe R, Suna E, Thompson IA. The Sensory Gating Inventory as a potential diagnostic tool for attention-deficit hyperactivity disorder. Atten Defic Hyperact Disord. 2012 Sep;4(3):141-4. doi: 10.1007/s12402-012-0079-1. Epub 2012 May 27. — View Citation

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. — View Citation

Swerdlow NR, Braff DL, Geyer MA. Cross-species studies of sensorimotor gating of the startle reflex. Ann N Y Acad Sci. 1999 Jun 29;877:202-16. Review. — View Citation

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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No