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Balance and Anti-Epileptic Drugs (AEDs)

Primary Purpose

Epilepsy

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Wii Balance Board
Sponsored by
Erik J. Kobylarz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Epilepsy

Eligibility Criteria

16 Years - 55 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dartmouth-Hitchcock Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Epilepsy Patients

Healthy Control Group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
October 20, 2017
Last Updated
August 3, 2018
Sponsor
Erik J. Kobylarz
Collaborators
American Epilepsy Society
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1. Study Identification

Unique Protocol Identification Number
NCT03338478
Brief Title
Balance and Anti-Epileptic Drugs
Acronym
AEDs
Official Title
Effect of Antiepileptic Drugs on Balance and Reaction Time
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
May 30, 2018 (Actual)
Study Completion Date
May 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Erik J. Kobylarz
Collaborators
American Epilepsy Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Epilepsy Patients
Arm Type
Experimental
Arm Description
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.
Arm Title
Healthy Control Group
Arm Type
Experimental
Arm Description
Patients without a diagnosis of epilepsy. Control participants will receive the Wii Balance Board and computerized reaction time testing.
Intervention Type
Diagnostic Test
Intervention Name(s)
Wii Balance Board
Intervention Description
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.
Primary Outcome Measure Information:
Title
Balance
Description
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.
Time Frame
Up to six weeks.
Title
Reaction Time
Description
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.
Time Frame
Up to six weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik Kobylarz, M.D., PhD
Organizational Affiliation
Dartmouth-Hitchcock Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual Participant Data is not planned to be shared with outside researchers.

Learn more about this trial

Balance and Anti-Epileptic Drugs

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