Methylphenidate Treatment of Attention Deficits in Epilepsy

Completed · Phase 4 · Has a placebo group

Conditions studied: Epilepsy, Cognitive Deficits, Attention Deficits

In brief

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.

Key facts

Study ID: NCT02178995
Run by: Kimford Jay Meador
People needed: 55
Starts: 2014-08-01
Expected to finish: 2015-12-01
Last updated by the study team: 2017-05-30

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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
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
English fluency

You may not qualify if…

IQ
History of an adverse reaction to methylphenidate
Age >65 or <18
Personal medical history of
Arrhythmias,
Structural cardiac disease,
Other cardiac abnormality
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.
Uncontrolled tachycardia during study
Progressive neurological disorders which may interfere w/ cognition for reasons other than seizures
Glaucoma
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).
Intellectual disability sufficient to render a participant unable to consent
Status epilepticus within the last year
Neurosurgery which would be expected to interfere with study tasks within the last 6 months.
Substance use history
Met criteria for substance use disorder within the past year
Active illicit substance use
Alcohol use meeting criteria for substance abuse
Unwillingness to abstain from alcohol w/in 24 hours of testing
Personal psychiatric history
History of a primary psychotic disorder, such as schizophrenia, or mania.
History of suicide attempts within the last year
Active suicidality
Severe cognitive impairments (e.g. aphasia) which render a participant unable to consent

Where it is running

Stanford University — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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