Balance and Anti-Epileptic Drugs (AEDs)

Effect of Antiepileptic Drugs on Balance and Reaction Time

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.

Study Overview

• Status: Completed
• Conditions: Epilepsy
• Intervention / Treatment: Diagnostic test: Wii Balance Board

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 55 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: 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.
Experimental: Healthy Control Group; Patients without a diagnosis of epilepsy. Control participants will receive the Wii Balance Board and computerized reaction time testing.	Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance	Balance measured by Wii Balance Board (WBB). The WBB has cells which detect load shifts in the body. Participants stand on both feet with eyes open; on both feet with eyes closed; on one foot with eyes open; and on one foot with eyes closed. Balancia software will be used to analyze the information.	Up to six weeks.
Reaction Time	Participants will use dominant hand on mouse to click as quickly as possible in response to a prompt on a computer screen. Five trials will be conducted at each visit.	Up to six weeks.

Collaborators and Investigators

• Sponsor: Erik J. Kobylarz
• Collaborators: American Epilepsy Society
• Investigators: Principal Investigator: Erik Kobylarz, M.D., PhD, Dartmouth-Hitchcock Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): May 30, 2018
• Study Completion (Actual): May 30, 2018

Study Registration Dates

• First Submitted: October 20, 2017
• First Submitted That Met QC Criteria: November 6, 2017
• First Posted (Actual): November 9, 2017

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 3, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy
• Other Study ID Numbers: D17186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual Participant Data is not planned to be shared with outside researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No