Acute Effect of Three Neuroactive Drugs Measured by Magnetoencephalography (MEG), Electroencephalography (EEG) and the Synchronous Neural Interaction Test

Overview[ - collapse ][ - ]

Purpose This placebo-controlled crossover study is intended to measure the effect of three, common neuroactive medications on brain activity measured by magnetoencephalography (MEG) and electroencephalography (EEG). This study will conduct MEG and EEG scans as well as simple cognition testing on 15 healthy volunteers over 4 study days. Subjects will receive placebo on one of the study days, and either 100 mg modafinil p.o., 20 mg methylphenidate p.o., or 1 mg lorazepam p.o. on remaining study days. Medication administration will be randomized according to study day so that each subject will receive the medications in random order. Brain activity will be measured by MEG and EEG in each subject a total of 4 times each study day: prior to medication administration and 2, 4, and 6 hours after medication administration. Cognition testing will be performed at pre-medication baseline and immediately after each post-medication scan time. This study will test the hypothesis that changes in brain functional activity can be accurately measured in healthy volunteer subjects after single, acute doses of modafinil, methylphenidate and lorazepam.
ConditionHealthy
InterventionDrug: modafinil
Drug: methylphenidate
Drug: lorazepam
Drug: placebo
PhaseN/A
SponsorOrasi Medical, Inc.
Responsible PartyOrasi Medical, Inc.
ClinicalTrials.gov IdentifierNCT00972985
First ReceivedSeptember 4, 2009
Last UpdatedJanuary 12, 2010
Last verifiedJanuary 2010

Tracking Information[ + expand ][ + ]

First Received DateSeptember 4, 2009
Last Updated DateJanuary 12, 2010
Start DateSeptember 2009
Estimated Primary Completion DateDecember 2009
Current Primary Outcome MeasuresThe primary outcome of the study will be identification and characterization of a pattern of synchronous brain activity that is specifically altered by administration of active medications compared to pre-medication baseline and placebo. [Time Frame: The study will require 5 days for each subject. Data collection for the study is expected to require approximately 12 weeks.] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • Standard frequency-domain analysis of the MEG data to identify and quantify medication-induced changes in signal power in particular frequency bands associated with brain functional activity [Time Frame: Data collection for the study is expected to require approximately 12 weeks.] [Designated as safety issue: No]
  • Standard frequency-domain and time-domain analysis of EEG data to generate direct comparisons between MEG and EEG results; [Time Frame: Data collection for the study is expected to require approximately 12 weeks.] [Designated as safety issue: No]
  • Orasi will apply its data analysis technology to the EEG data in an effort to compare the time-domain correlations measured by EEG to those measured with MEG; [Time Frame: Data collection for the study is expected to require approximately 12 weeks.] [Designated as safety issue: No]
  • Orasi will compare the pattern of cross-correlations observed with medications to those observed in our database of healthy and disease subjects; [Time Frame: Data collection for the study is expected to require approximately 12 weeks.] [Designated as safety issue: No]
  • The results of standard cognitive tests designed to identify the known effects of medications. [Time Frame: Data collection for the study is expected to require approximately 12 weeks.] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief TitleAcute Effect of Three Neuroactive Drugs Measured by Magnetoencephalography (MEG), Electroencephalography (EEG) and the Synchronous Neural Interaction Test
Official TitleAcute Effect of Three Neuroactive Drugs on Brain Activity Measured by MEG, EEG and the Synchronous Neural Interaction Test
Brief Summary
This placebo-controlled crossover study is intended to measure the effect of three, common
neuroactive medications on brain activity measured by magnetoencephalography (MEG) and
electroencephalography (EEG). This study will conduct MEG and EEG scans as well as simple
cognition testing on 15 healthy volunteers over 4 study days. Subjects will receive placebo
on one of the study days, and either 100 mg modafinil p.o., 20 mg methylphenidate p.o., or 1
mg lorazepam p.o. on remaining study days. Medication administration will be randomized
according to study day so that each subject will receive the medications in random order.
Brain activity will be measured by MEG and EEG in each subject a total of 4 times each study
day: prior to medication administration and 2, 4, and 6 hours after medication
administration. Cognition testing will be performed at pre-medication baseline and
immediately after each post-medication scan time. This study will test the hypothesis that
changes in brain functional activity can be accurately measured in healthy volunteer
subjects after single, acute doses of modafinil, methylphenidate and lorazepam.
Detailed Description
This study uses a placebo-controlled, crossover design to investigate the effect of
modafinil (100 mg, p.o.), methylphenidate (20 mg, p.o.), and lorazepam (1 mg, p.o.) in 15
healthy male volunteers. The acute effect of the medications will be measured by MEG, EEG
and simple cognition testing. Study procedures will be performed over 5 separate days.
During an initial screening visit, Study Day 1, subjects will consent to enroll and undergo
clinical evaluation sufficient to determine they are eligible to participate in the study.
Upon qualification and enrollment, subjects will be randomly assigned to receive either
placebo or one of the active medications on Study Days 2 - 5. Medications or placebo will be
administered orally. Subjects will arrive at the MEG center in the morning on Study Day 2
and baseline MEG and EEG scans will be performed along with baseline cognition testing. The
medication or placebo will be administered immediately following the baseline scans and
cognition testing. Additional MEG and EEG scans will be conducted 2, 4, and 6 hours after
medication or placebo administration. On Study Days 3 - 5, subjects will undergo identical
procedures but will be crossed over to receive the alternate medication or placebo.
Study TypeInterventional
Study PhaseN/A
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
ConditionHealthy
InterventionDrug: modafinil
oral tablet, 100 mg, single acute dose
Other Names:
ProvigilDrug: methylphenidate
oral tablet, 20 mg, single acute dose
Other Names:
RitalinDrug: lorazepam
oral tablet, 1 mg, single, acute dose
Other Names:
AtivanDrug: placebo
oral tablet, single acute dose
Other Names:
sugar pill
Study Arm (s)
  • Experimental: modafinil
    All healthy control subjects receive modafinil in this crossover design
  • Experimental: methylphenidate
    All healthy control subjects receive methylphenidate in this crossover design
  • Experimental: lorazepam
    All healthy control subjects receive lorazepam in this crossover design
  • Placebo Comparator: placebo
    All healthy control subjects receive placebo in this crossover design

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment15
Estimated Completion DateDecember 2009
Estimated Primary Completion DateDecember 2009
Eligibility Criteria
Inclusion Criteria:

- Subject is male between 18 and 35 years of age at the time of screening.

- Subject understands the study procedures and agrees to participate in the study by
giving written informed consent.

- Subject is a non-smoker.

- Subject is judged to be in good health based on medical history and brief physical
examination.

- Subject has normal or corrected to normal visual and auditory acuity.

- Subject agrees to refrain from caffeine 24 hours prior to and then throughout each
Study Day.

- Subject agrees to refrain from using alcohol for 48 hours prior to and then
throughout each Study Day.

Exclusion Criteria:

- Subject has a diagnosis of a significant neurological condition including Alzheimer's
disease, Parkinson's disease, vascular dementia, Lewy body dementia or frontal
temporal dementia, human immunodeficiency virus, multiple sclerosis, or severe
traumatic brain injury.

- Subject has a history of primary psychotic disorder (e.g. schizophrenia,
schizoaffective disorder, delusional disorder) or bipolar disorder.

- Subject has a history of seizures, epilepsy, stroke, peripheral neuropathy, head
trauma with persistent post-concussive symptoms, ADHD, dyslexia or other clinically
significant neurological disease or cognitive impairment.

- Subject has a lifetime or current history of alcohol or substance abuse/dependence.

- Subject has a history of multiple or severe allergies, or has had an anaphylactic
reaction or intolerability to prescription or non-prescription drugs or food. This
includes a documented or subject-verified allergy.

- Subject had an MRI 2 weeks prior to Study Day 2.

- Subject has metal braces or pacemaker that may interfere with the MEG scan.

- Subject is unable to complete the MEG scan procedure.

- The investigator has any concern regarding the safe participation of a subject in the
study, or if for any other reason the investigator considers the subject
inappropriate for study participation.
GenderMale
Ages18 Years
Accepts Healthy VolunteersAccepts Healthy Volunteers
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00972985
Other Study ID NumbersADE 09-01
Has Data Monitoring CommitteeNo
Information Provided ByOrasi Medical, Inc.
Study SponsorOrasi Medical, Inc.
CollaboratorsNot Provided
Investigators Principal Investigator: Concetta Forchetti, MD, PhD Alexian Brothers Neuroscience Institute
Verification DateJanuary 2010

Locations[ + expand ][ + ]

Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois, United States, 60007