RECRUITING

Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits

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Conditions

Epilepsyattentionmemorycognitionseizure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Methylphenidate for the Treatment of Epilepsy-related Cognitive Deficits: a Randomized, Double-blind, Placebo-controlled Trial

Quick Facts

Study Start:2023-08-14
Study Completion:2027-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04419272

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. SUBJECTS WITH EPILEPSY
  2. * Age 18 years of age or older;
  3. * Capacity to provide informed consent;
  4. * Ability to live independently and complete activities of daily living;
  5. * Stable seizure frequency at the time of enrollment, such that the subject's treating physician does not believe a change in ASM regimen to be warranted during the trial (ASMs should remain unchanged during the 16 weeks of participation unless absolutely required clinically due an unanticipated change in seizure frequency or severity);
  6. * Fluency in written and spoken English.
  7. 2. CONTROLS \*DO NOT UNDERGO ANY DRUG OR PLACEBO INTERVENTION Two additional subject groups will be included, to control for effects of repeated testing in the open-label extension phase: healthy subjects and epilepsy patients without cognitive complaints, who will not receive the study drug at any point during the study. Epilepsy patients without cognitive deficits must otherwise meet all of the above criteria.
  1. * Psychogenic, non-epileptic spells
  2. * Delirium in the past year
  3. * Other progressive neurologic illness (i.e., malignant brain tumor). A benign, stable neoplasm with no plans for resection will not be cause for exclusion.
  4. * A history of alcohol or illicit drug abuse;
  5. * Generalized tonic-clonic or other generalized motor seizure(s) within 48 hours or focal-onset seizures with impaired awareness within 24 hours of neuropsychological testing;
  6. * Status epilepticus in the past year;
  7. * Neurosurgery within the past 6 months;
  8. * Suicide attempt in the past year and/or high-risk suicide flag in the medical record;
  9. * Psychotic disorders
  10. * Severe anxiety (\>26 on the Beck Anxiety Inventory \[BAI\]) and impulse control disorders;
  11. * Untreated sleep disorders;
  12. * Use of narcotic or other sedating medications within 6 hours of testing (i.e., diphenhydramine);
  13. * Concurrent severe major medical illness (i.e., cancer requiring chemotherapy or resection)
  14. * Prior transient ischemic attack (TIA) or stroke
  15. * Current pregnancy or pregnancy planned during the trial
  16. * Breastfeeding
  17. * Concurrent treatment with a monoamine oxidase inhibitor (MAOI) or MAOI use within 14 days of beginning the trial;
  18. * Structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, or coronary artery disease (including a history of myocardial infarction, cardiac stent placement, coronary artery bypass graft surgery, or angina);
  19. * Bipolar disorders;
  20. * Concurrent use of medications for erectile dysfunction (e.g., tadalafil, sildenafil);
  21. * Use of medications that may lower seizure threshold (e.g., tramadol, bupropion) or induce psychosis (i.e., varenicline);
  22. * Known allergy or intolerance to MPH;
  23. * Uncontrolled hypertension;
  24. * History of seizures, epilepsy, or psychogenic, non-epileptic spells;
  25. * Diagnosis of dementia (i.e., Alzheimer's disease), MoCA score of \<26;
  26. * Delirium in the past year;
  27. * Other progressive neurologic illness (i.e., malignant brain tumor);
  28. * Prior moderate or severe traumatic brain injury (TBI);
  29. * Mild TBI within the past 6 months;
  30. * A history of alcohol or illicit drug abuse;
  31. * Suicide attempt in the past year and/or high-risk suicide flag in the medical record;
  32. * Psychotic, severe anxiety (BAI \>26), or impulse control disorders;
  33. * Untreated sleep disorders;
  34. * Use of narcotic or other sedating medications within 6 hours of testing;
  35. * Ongoing major neurological or medical illness (i.e., cancer requiring chemotherapy or resection);
  36. * Prior TIA or stroke;

Contacts and Locations

Study Contact

Beth A Leeman-Markowski, MD
CONTACT
(212) 686-7500
beth.leeman-markowski@va.gov
Samantha P Martin, MA
CONTACT
(212) 685-7500
Samantha.Martin1@va.gov

Principal Investigator

Beth A Leeman-Markowski, MD
PRINCIPAL_INVESTIGATOR
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Study Locations (Sites)

Miami VA Healthcare System, Miami, FL
Miami, Florida, 33125
United States
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, 02130-4817
United States
Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY
New York, New York, 10010-5011
United States
VA Portland Health Care System, Portland, OR
Portland, Oregon, 97207-2964
United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

  • Beth A Leeman-Markowski, MD, PRINCIPAL_INVESTIGATOR, Manhattan Campus of the VA NY Harbor Healthcare System, New York, NY

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-14
Study Completion Date2027-09-30

Study Record Updates

Study Start Date2023-08-14
Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

  • attention
  • memory
  • cognition
  • seizure

Additional Relevant MeSH Terms

  • Epilepsy