Balance and Anti-Epileptic Drugs



Status:Completed
Conditions:Neurology, Epilepsy
Therapuetic Areas:Neurology, Other
Healthy:No
Age Range:16 - 55
Updated:8/8/2018
Start Date:December 1, 2017
End Date:May 30, 2018

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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.

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.

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
We found this trial at
1
site
1 Medical Center Dr
Lebanon, New Hampshire 03756
 (603) 650-5000
Principal Investigator: Alendia L. Hartshorn, M.D.
Phone: 603-650-5104
Dartmouth Hitchcock Medical Center Dartmouth-Hitchcock is a national leader in patient-centered health care and building...
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