Psychostimulants Effects on Brain Functional Connectivity in Youth With Attention Deficit Hyperactivity Disorder

NCT02318017 | Unknown

• 1 other identifier: SHEBA-14-1351-IH-CTIL
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

In the current study, we will administer three widely administered cognitive tasks while simultaneously measuring electroencephalography (EEG) in ADHD patients before and after methylphenidate immediate release (IR) treatment compared to placebo. In addition we will compare the effective connectivity dynamics to normal subjects. Using this novel network analysis approach, we will attempt to address the currently limited cognitive network literature. We will attempt to map the connectivity between the discrete brain regions during the execution of the tasks before and after treatment with methylphenidate IR. Comparison with healthy control subjects will enable us to determine whether the direction of methylphenidate induced changes in brain functioning (in youths with ADHD) will be toward or away from normal connectivity patterns. We will also examine whether network patterns differ between the healthy controls and the ADHD patients.

Conditions

Adhd

Keywords

adhd; global network; eeg

Outcome Measures

Primary Outcomes (2)

• Baseline Complex Network connectivity before treatment - using electrodes signal correlation (P-value)

  Complex network is measured by metrics that are calculated using graph-theory analysis methods that enable the characterization of the architecture of complex networks. The network is constructed from the EEG signals by correlating the signals between all pairs of electrodes, assuming that each two electrodes that are correlated above a pre-determined threshold are functionally connected and with higher correlation the higher network connectivity. Assessed at baseline before MPH\\Placebo according to the above time frames.

  0 minutes

• Baseline Complex Network connectivity after treatment - using electrodes signal correlation (P-value)

  Complex network is measured by metrics that are calculated using graph-theory analysis methods that enable the characterization of the architecture of complex networks. The network is constructed from the EEG signals by correlating the signals between all pairs of electrodes, assuming that each two electrodes that are correlated above a pre-determined threshold are functionally connected and with higher correlation the higher network connectivity. Assessed at baseline after MPH\\Placebo according to the above time frames.

  90 minutes

Secondary Outcomes (6)

• Complex Network connectivity at Sustained Attention task before treatment - using electrodes signal correlation (P-value)

  11 minutes

• Complex Network connectivity at N-Back task before treatment - using electrodes signal correlation (P-value)

  24 minutes

• Complex Network connectivity at the Stroop task before treatment - using electrodes signal correlation (P-value)

  30 minutes

• Complex Network connectivity at Sustained Attention task after treatment - using electrodes signal correlation (P-value)

  101 minutes

• Complex Network connectivity at N-Back task after treatment - using electrodes signal correlation (P-value)

  114 minutes

Study Arms (2)

Methylphenidate

ACTIVE COMPARATOR

Methylphenidate 0.5mg/kg - once

Drug: Methylphenidate

Placebo

PLACEBO COMPARATOR

Placebo - once

Drug: Placebo

Interventions

Methylphenidate DRUG

Before neurocognitive testing, Methylphenidate/Placebo will be given

Also known as: MPH

Methylphenidate

Placebo DRUG

Placebo

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents which are being considered for methylphenidate treatment and therefore referred to computerized cognitive tasks with and without methylphenidate IR use as part of their management

You may not qualify if:

• study group: Age fewer than 6 and above 18, history of seizure, head trauma, substance abuse or medication other than stimulants, inability to swallow pills.
• control group: Age fewer than 6 and above 18, history of seizure, head trauma, substance abuse, current medication use. Current or lifetime psychiatric disorders.

Sponsors & Collaborators

• Sheba Medical Center: lead
• Weizmann Institute of Science: collaborator

Study Sites (1)

Sheba medical center

Tel Litwinsky, Israel

Location

Related Publications (1)

• Rubinson M, Horowitz I, Naim-Feil J, Gothelf D, Moses E, Levit-Binnun N. Electroencephalography Functional Networks Reveal Global Effects of Methylphenidate in Youth with Attention Deficit/Hyperactivity Disorder. Brain Connect. 2019 Jun;9(5):437-450. doi: 10.1089/brain.2018.0630. Epub 2019 May 23.

  PMID: 30919658 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Methylphenidate; 5,10-dihydro-5-methylphenazine

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

• Doron Gothelf, Prof.

  , . 972-3-5303810

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Itai Horowitz, MD

CONTACT

972503370579; itaizen@gmail.com

Gita Veiber, Msc

CONTACT

972353810; gita.veiber@sheba.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2014
• First Posted: December 17, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: December 17, 2014

Record last verified: 2014-12

Locations

IL (1)