Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:07 PM
Ignite Modification Date:
2025-12-24 @ 2:07 PM
NCT ID:
NCT02178995
Eligibility Criteria:
Inclusion Criteria:
1. For participants with seizures:
* H/o seizures of any cause
* Subjective cognitive complaints
* Stable antiepileptic drug doses which are not expected to change during the study
* Recent normal cardiac auscultation (may be done prior to enrollment by personal physician or study staff)
* Neurologist's judgement that participant is clinically appropriate for this study
2. For healthy volunteers
* No history of seizures or other neurological disorders
* No history of cognitive complaints for any reason (including ADHD)
* Not on any medications which would interfere w/ cognitive testing
3. English fluency
Exclusion Criteria:
1. IQ
2. History of an adverse reaction to methylphenidate
3. Age \>65 or \<18
4. Personal medical history of
1. Arrhythmias,
2. Structural cardiac disease,
3. Other cardiac abnormality
4. Uncontrolled hypertension (\>150/95) during study. For those with BP \>140/90 \& \<150/95, they will be monitored during the study and refer them for treatment if their BP remains elevated throughout the study.
5. Uncontrolled tachycardia during study
6. Progressive neurological disorders which may interfere w/ cognition for reasons other than seizures
7. Glaucoma
8. Other medical or neurological illnesses or symptoms which may interfere with cognition or medication (e.g., severe liver or renal disease, active infections, etc), or which make use of the medication inappropriate (e.g., severe agitation/anxiety).
9. Intellectual disability sufficient to render a participant unable to consent
10. Status epilepticus within the last year
11. Neurosurgery which would be expected to interfere with study tasks within the last 6 months.
5. Substance use history
1. Met criteria for substance use disorder within the past year
2. Active illicit substance use
3. Alcohol use meeting criteria for substance abuse
4. Unwillingness to abstain from alcohol w/in 24 hours of testing
6. Personal psychiatric history
1. History of a primary psychotic disorder, such as schizophrenia, or mania.
2. History of suicide attempts within the last year
3. Active suicidality
7. Severe cognitive impairments (e.g. aphasia) which render a participant unable to consent
8. Currently receiving medications which would be expected to interfere with the study tasks, if they cannot be held for study visits;
9. Pregnancy or active breastfeeding;
10. Women of childbearing potential who are sexually active and not willing or able to use a contraceptive strategy during the course of the study.
11. Any other factor which may interfere w/ a participant's ability to consent or to complete the required cognitive tasks, or may significantly interfere with their performance on the required tests
12. Concomitant use of an MAOI (if receiving methylphenidate during this study), or use of an MAOI within the last 14 days prior to receiving methylphenidate.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02178995
Study Brief:
Protocol Section:
NCT02178995