Methylphenidate Treatment of Attention Deficits in Epilepsy
Condition: Epilepsy; Cognitive Deficits; Attention Deficits
MeSH terms: Epilepsy; Attention Deficit Disorder with Hyperactivity; Cognition Disorders; Cognitive Dysfunction
Intervention: Methylphenidate
Intervention description: Participants with epilepsy will first receive blinded, single-dose capsules which contain either:
Placebo 20mg of methylphenidate or 10mg of methylphenidate.
At each visit, they will receive one capsule and then complete the neurocognitive batteries and neuropsychiatric questionnaires. There will be no medication administered between visits during this time. Following the final randomized visit, interested participants will be prescribed 10mg of methylphenidate twice daily, to be increased to 20mg of methylphenidate twice daily. After four weeks, their scores on the batteries and questionnaires will again be assessed.
Intervention MeSH terms: Methylphenidate
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 55.0
Sex: All
Minimum age: 18 Years
Maximum age: 65 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Methylphenidate (MPH) has long been used to improve attention and cognitive difficulties
      associated with ADHD, including in children with ADHD and epilepsy (Torres et al., 2008).
      Methylphenidate (MPH) is also helpful in treating attention and other cognitive difficulties
      in a variety of other neurological and medical conditions (Kajs-Wyllie, 2002; Prommer, 2012).
      We seek to evaluate the potential efficacy and safety of this medication in treating
      attention deficits, as well as other cognitive difficulties, experienced by adult patients
      with epilepsy.

      To our knowledge, there are currently very few studies which explicitly examine the impact of
      MPH on measureable attention deficits and other cognitive deficits in adult patients with
      epilepsy. We hope to quantify what impact, if any, methylphenidate has on attention, in
      addition to other specific measureable cognitive functions, in patients with cognitive
      complaints and epilepsy, and contribute to a growing body of evidence which supports the
      safety of methylphenidate's use for attention deficits in patients with epilepsy. As other
      effective treatments for attention and other cognitive difficulties in patients with epilepsy
      are not currently available, MPH could represent an important option in the treatment of such
      patients.
    

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.