Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Balance and Anti-Epileptic Drugs (AEDs)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03338478
Recruitment Status : Completed
First Posted : November 9, 2017
Last Update Posted : August 6, 2018
Sponsor:
Collaborator:
American Epilepsy Society
Information provided by (Responsible Party):
Erik J. Kobylarz, Dartmouth-Hitchcock Medical Center

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.

Condition or disease Intervention/treatment Phase
Epilepsy Diagnostic Test: Wii Balance Board Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Effect of Antiepileptic Drugs on Balance and Reaction Time
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : May 30, 2018
Actual Study Completion Date : May 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Epilepsy

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.




Primary Outcome Measures :
  1. Balance [ Time Frame: Up to six weeks. ]
    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.

  2. Reaction Time [ Time Frame: Up to six weeks. ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   16 Years to 55 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338478


Locations
Layout table for location information
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Sponsors and Collaborators
Erik J. Kobylarz
American Epilepsy Society
Investigators
Layout table for investigator information
Principal Investigator: Erik Kobylarz, M.D., PhD Dartmouth-Hitchcock Medical Center

Layout table for additonal information
Responsible Party: Erik J. Kobylarz, Fellow, GME Epilepsy, Dartmouth-Hitchcock Medical Center
ClinicalTrials.gov Identifier: NCT03338478     History of Changes
Other Study ID Numbers: D17186
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: August 6, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individual Participant Data is not planned to be shared with outside researchers.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Epilepsy
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases