Actively Recruiting
Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits
Led by VA Office of Research and Development · Updated on 2026-04-20
226
Participants Needed
4
Research Sites
250 weeks
Total Duration
On this page
Sponsors
V
VA Office of Research and Development
Lead Sponsor
V
VA New York Harbor Healthcare System
Collaborating Sponsor
AI-Summary
What this Trial Is About
Methylphenidate (MPH) is a stimulant, FDA-approved for the treatment of attention deficit hyperactivity disorder (ADHD). It is unknown, however, if stimulants would be of benefit for memory and thinking problems due to epilepsy. In this study, participants will be assigned randomly (i.e., by flip of a coin), to a group that takes MPH and a group that takes a placebo (sugar pill). Participants will not know the group to which they have been assigned. Tests of attention and memory will be completed before taking the study pills and at Week 8. All participants will then have the option of taking MPH for the next two months, and attention and memory will be tested again at Week 16. The study will determine whether methylphenidate is helpful for the treatment of attention and memory problems in adults with epilepsy, and whether the medication is safe and beneficial when taken over an extended time period.
CONDITIONS
Official Title
Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Diagnosis of focal-onset epilepsy confirmed by clinical history, imaging, and EEG
- Self-reported cognitive dysfunction
- Capacity to provide informed consent
- Ability to live independently and complete daily activities
- Stable seizure frequency with no planned changes in anti-seizure medications during the trial
- Fluency in written and spoken English
- Healthy controls and epilepsy patients without cognitive complaints must meet similar criteria except they do not receive study drug
You will not qualify if you...
- Psychogenic, non-epileptic seizures
- Delirium within the past year
- Progressive neurological illness such as malignant brain tumor
- History of alcohol or illicit drug abuse
- Generalized seizures within 48 hours or focal seizures with impaired awareness within 24 hours of cognitive testing
- Status epilepticus in the past year
- Neurosurgery within the previous 6 months
- Active suicidal plan or intent in the past 6 months, history of multiple suicide attempts, or current high suicide risk
- Psychotic disorders
- Severe anxiety (Beck Anxiety Inventory score >26) or impulse control disorders
- Untreated sleep disorders
- Use of narcotic or sedating medications within 6 hours of testing
- Severe major medical illness such as cancer requiring chemotherapy or surgery
- Prior transient ischemic attack or stroke
- Diagnosis of dementia or Alzheimer's disease
- For participants with cognitive complaints, Montreal Cognitive Assessment score below 18
- For participants without cognitive complaints, Montreal Cognitive Assessment score below 26
- Current pregnancy or planned pregnancy during the study
- Breastfeeding
- Use of monoamine oxidase inhibitors within 14 days before study start
- Structural heart problems or serious cardiac conditions
- Bipolar disorder
- Use of medications for erectile dysfunction
- Use of medications that lower seizure threshold or cause psychosis
- Allergy or intolerance to methylphenidate
- Uncontrolled high blood pressure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Miami VA Healthcare System, Miami, FL
Miami, Florida, United States, 33125
Actively Recruiting
2
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130-4817
Actively Recruiting
3
VA NY Harbor Healthcare System, New York, NY
New York, New York, United States, 10010-5011
Actively Recruiting
4
VA Portland Health Care System, Portland, OR
Portland, Oregon, United States, 97207-2964
Actively Recruiting
Research Team
B
Beth A Leeman-Markowski, MD
CONTACT
S
Samantha P Martin, MA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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