Attention Deficit DisorderPPINCT02344784
The Characteristics of Prepulse Inhibition in Children and Adolescents Suffering From Attention Deficit Disorder
An observational study of Attention Deficit Disorder, run by HaEmek Medical Center, Israel at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Attention Deficit Disorder
- What is being tested?
- SR-HLAB EMG and Methylphenidate
- Type of treatment
- Medical device
- How many people
- 46 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2015to Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 9Show fewer
- Contraindicated for the treatment of methylphenidate.
- Hearing problems.
- Pregnancy week 20 and thereafter
Trial locations and contacts
1 site in 1 country.
Israel1 site
The mental health clinic for children and adolescents at the HaEmek Medical Center
Afula, 18101
About this study
Official title: 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.
Read more
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
- Being tested
- SR-HLAB EMG, Methylphenidate
- Keywords
- ADD, ADHD, PPI
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR-HLAB EMGDevice
Prepulse inhibition test using SR-HLAB EMG device will record the acoustic startle response for each participant: with and without Methylphenidate treatment
MethylphenidateDrug
Also called Ritalin
The regular daily dose of P.O methylphenidate of each participant will be given directly after the first prepulse inhibition test
What is being measured
The primary outcome is the main question the study is designed to answer.
Electromyography (EMG) of the right and the left Orbicularis oculi muscle will be recorded during the Prepulse inhibition test
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJan 2015
- Primary completionMar 2017 (estimated)
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- HaEmek Medical Center, Israel
- Sponsor type
- University, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Responsible party
- Principal investigator, ESSAM DAOD, HaEmek Medical Center, Israel
- Investigators
- AVRAHAM AVITAL, Study chair, Technion, Israel Institute of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02344784
- Sponsor's protocol ID
- HaEmekMC
- Other IDs
- 0071-14
- Acronym
- PPI
- Status last verified
- Aug 2016
- First submitted
- 16 Jan 2015
- Last updated
- 23 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 18998276Faraone 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. doi: 10.1017/S003329170500471X.
PubMed 16420712Larson 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.
PubMed 21300675Biederman 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.
PubMed 14658924Ornitz 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.
PubMed 1410175Castellanos 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.
PubMed 8719124Ornitz 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.
PubMed 10356628Braff 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.
PubMed 11549226Hawk 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.
PubMed 12417963Feifel 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.
PubMed 18674783Hanlon 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.
PubMed 19046483Ashare 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.
PubMed 20233343Takahashi 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.
PubMed 23429840Sable 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.
PubMed 22644992Schulz-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.
PubMed 22713361
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Characteristics of Prepulse Inhibition in Children and Adolescents Suffering From Attention Deficit Disorder: With and Without Medication.
- ClinicalTrials.gov ID
- NCT02344784
- Acronym / sponsor ID
- PPI / HaEmekMC
- Conditions
- Attention Deficit Disorder
- Keywords
- ADD, ADHD, PPI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (actual)
- Lead sponsor
- HaEmek Medical Center, IsraelUniversity, hospital or other
- Collaborators
- Technion, Israel Institute of Technology
- Study start
- Jan 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SR-HLAB EMGPrepulse inhibition test using SR-HLAB EMG device will record the acoustic startle response for each participant: with and without Methylphenidate treatment | Device | – |
| MethylphenidateAlso: RitalinThe regular daily dose of P.O methylphenidate of each participant will be given directly after the first prepulse inhibition test | Drug | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2016.
- Background: PubMed 18998276Pastor PN, Reuben CA. Diagnosed attention deficit hyperactivity disorder and learning disability: United States, 2004-2006. Vital Health Stat 10. 2008 Jul;(237):1-14.
- Background: PubMed 16420712Faraone 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. doi: 10.1017/S003329170500471X.
- Background: PubMed 21300675Larson 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.
- Background: PubMed 14658924Biederman 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.
- Background: PubMed 1410175Ornitz 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.
- Background: PubMed 8719124Castellanos 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.
- Background: PubMed 10356628Ornitz 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.
- Background: PubMed 11549226Braff 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.
- Background: PubMed 12417963Hawk 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.
- Background: PubMed 18674783Feifel 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.
- Background: PubMed 19046483Hanlon 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.
- Background: PubMed 20233343Ashare 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
AVRAHAM AVITAL study chair
Technion, Israel Institute of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit Disorder, run by HaEmek Medical Center, Israel at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02344784, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2016.