Acute Effect of Three Neuroactive Drugs Measured by Magnetoencephalography (MEG), Electroencephalography (EEG) and the Synchronous Neural Interaction Test
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 35 |
| Updated: | 10/14/2017 |
| Start Date: | September 2009 |
| End Date: | December 2009 |
Acute Effect of Three Neuroactive Drugs on Brain Activity Measured by MEG, EEG and the Synchronous Neural Interaction Test
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.
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.
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.
(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.
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.
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