Balance and Anti-Epileptic Drugs

NCT03338478 | Completed

• 1 other identifier: D17186
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Epilepsy Patients

EXPERIMENTAL

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

Healthy Control Group

EXPERIMENTAL

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

Diagnostic Test: Wii Balance Board

Interventions

Wii Balance Board 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.

Epilepsy Patients; Healthy Control Group

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Erik J. Kobylarz: lead
• American Epilepsy Society: collaborator

Study Sites (1)

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Erik Kobylarz, M.D., PhD

  Dartmouth-Hitchcock Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Fellow, GME Epilepsy

Study Record Dates

• First Submitted: October 20, 2017
• First Posted: November 9, 2017
• Study Start: December 1, 2017
• Primary Completion: May 30, 2018
• Study Completion: May 30, 2018
• Last Updated: August 6, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)