Balance and Anti-Epileptic Drugs

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-01

Study Completion Date

2018-05-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Patients with epilepsy exercise less than the general population. A barrier to exercise may be the effect of antiepileptic drugs on balance and reaction time. This proposal endeavors to study the effect of two common antiepileptic drugs (levetiracetam and lamotrigine) on balance and reaction time using a Wii balance board and reaction time test. This will be tested at descending doses in an epilepsy monitoring unit. Drug levels will be monitored, as well as center of pressure, and reaction time.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Levetiracetam on Brain Excitability

NCT00006191

Healthy Myoclonic Epilepsy

COMPLETED

Effects of Keppra on Thinking, Emotions, and Balance in Elderly Healthy Volunteers

NCT00221988

Epilepsy

COMPLETED NA

The GABAergic Inhibitory System in Drug Resistant Epilepsy

NCT06789497

Drug Resistant Epilepsy Temporal Lobe Epilepsy

COMPLETED NA

B6 Administration for Levetiracetam-Associated Neurobehavioral Changes and Epilepsy

NCT07271966

Brain Tumor Related Epilepsy (BTRE)

NOT_YET_RECRUITING NA

Assess Safety and Efficacy of Levetiracetam(LEV;Keppra)for Seizure Prevention

NCT00618436

Traumatic Brain Injury Subarachnoid Hemorrhage

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients with epilepsy (PWE) exercise less compared to the general population. One barrier to participation in exercise is the subtle effect of anti epileptic drugs (AEDs) on balance and reaction time. Information on these measures in PWE is scarce, although previous data does suggest a detrimental effect. The objective of this trial is to study balance and reaction time in patients taking common AEDs. The investigators plan to study the effect of levetiracetam and lamotrigine on balance and reaction time. By studying patients in the epilepsy monitoring unit who are undergoing medication taper and withdrawal, the investigators can observe the effects of varying doses of these drugs within a single subject and also compare these data points to age matched controls. A Wii balance board (WBB) will be used to measure balance. It is hypothesized that levetiracetam and lamotrigine will elicit a dose-dependent, detrimental effect on balance and reaction time.

Patients admitted to the epilepsy monitoring unit who are currently taking levetiracetam or lamotrigine either in monotherapy will be recruited for the study. The target enrollment is 20 PWE, and 20 healthy controls.

For the PWE in the study, baseline AED blood levels will be obtained at baseline. The WBB has cells which detect load shifts in the body. Participants will stand on the WBB and remain as steady as possible. First on both feet with eyes open for 30 seconds, and then on both feet with eyes closed for 30 seconds, then on one foot with eyes open for 10 seconds, and then on one foot with eyes closed for 10 seconds. Each task will have 3 trials, with adequate break between.

Visit 2 will occur following weaning of AEDs. The investigators will measure center of pressure and reaction time testing similar to visit one. Blood AED levels will be checked at three half lives of the medication. This will be taken within 8 hours of visit 2.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Epilepsy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Epilepsy Patients

Patients being tapered off of levetiracetam or lamotrigine monotherapy during epilepsy video monitoring. Patients will receive the Wii Balance Board and computerized reaction time testing.

Group Type EXPERIMENTAL

Wii Balance Board

Intervention Type DIAGNOSTIC_TEST

Participants will stand on the Wii Balance Board with eyes open, eyes closed, one two feet, and then standing on one leg at each study visit.

Healthy Control Group

Patients without a diagnosis of epilepsy. Control participants will receive the Wii Balance Board and computerized reaction time testing.

Group Type EXPERIMENTAL

Wii Balance Board

Intervention Type DIAGNOSTIC_TEST

Participants will stand on the Wii Balance Board with eyes open, eyes closed, one two feet, and then standing on one leg at each study visit.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Wii Balance Board

Participants will stand on the Wii Balance Board with eyes open, eyes closed, one two feet, and then standing on one leg at each study visit.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Focal or generalized epilepsy
* On a stable dose of AEDs defined by no medication changes within the last month.
* On levetiracetam or lamotrigine monotherapy

Exclusion Criteria

* Inability to stand independently for 30 seconds
* Peripheral neuropathy
* History of stroke or previous brain surgery
* Seizure within last 24 hours

Minimum Eligible Age

16 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes