Methylphenidate Treatment of Attention Deficits in Epilepsy
Recruitment status was Not yet recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Methylphenidate Treatment of Attentional and Cognitive Deficits in Epilepsy|
- Conners' continuous performance test (CPT) [ Time Frame: difference of 2 treatments (randomized to weeks 2, 3, or 4) from placebo (randomized to week 2, 3 or 4) ] [ Designated as safety issue: No ]Scores on this test measure attentiveness/vigilance and response time. Primary measure will be confidence interval differences.
- Seizure frequency/severity [ Time Frame: Change from baseline (day 1) to methylphenidate treatments (single doses randomized to weeks 2, 3, or 4, and end of one month treatment at end month 2) ] [ Designated as safety issue: Yes ]Seizure diaries will be monitored for changes in seizure frequency and/or severity associated with methylphenidate use during 2 single dose exposures and during 1 month open label.
- Symbol-digit matching test [ Time Frame: difference of 2 treatments (randomized to weeks 2, 3, or 4) from placebo (randomized to week 2, 3 or 4) ] [ Designated as safety issue: No ]Symbol-digit matching test is a measure processing speed and working memory.
- MCG paragraph memory test [ Time Frame: difference of 2 treatments (randomized to weeks 2, 3, or 4) from placebo (randomized to week 2, 3 or 4) ] [ Designated as safety issue: No ]MCG paragraph memory test is a measure verbal memory.
- Beck Depression Inventory [ Time Frame: Change from baseline to end of methylphenidate open label treatment (end month 2) ] [ Designated as safety issue: No ]Beck Depression Inventory is a questionnaire to assess mood.
- Beck Anxiety Inventory [ Time Frame: Change from baseline to end of methylphenidate open label treatment (end month 2) ] [ Designated as safety issue: No ]Beck Anxiety Inventory is a questionnaire to assess anxiety.
- QOLIE-89 [ Time Frame: Change from baseline to end of methylphenidate open label treatment (end month 2) ] [ Designated as safety issue: No ]QOLIE-89 is a questionnaire to assess quality of life and subjective cognitive effects.
|Study Start Date:||August 2014|
|Estimated Study Completion Date:||May 2015|
|Estimated Primary Completion Date:||April 2015 (Final data collection date for primary outcome measure)|
Experimental: Participants with epilepsy
Participants will receive three single doses of blinded medication, either a placebo, 20mg of methylphenidate, or 40mg of methylphenidate, and will complete cognitive testing and neuropsychiatric questionnaires. This single-dose phase will be followed by an open-label 4-week treatment trial of methylphenidate.
Participants with epilepsy will first receive blinded, single-dose capsules which contain either:
Placebo 20mg of methylphenidate or 40mg 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.
Other Name: Ritalin
No Intervention: Healthy Controls
Healthy controls will complete the same neurocognitive batteries and neuropsychiatric questionnaires as individuals with epilepsy, but will not be exposed to study medication.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02178995
|Contact: Kimford Meador, MD||650-275-6648|
|United States, California|
|Stanford University||Not yet recruiting|
|Palo Alto, California, United States, 94305|
|Study Director:||Jesse M Adams, MD||Stanford University|
|Principal Investigator:||Kimford Meador, MD||Stanford University|
|Study Chair:||John Barry, MD||Stanford University|