Chapter 4. Subjects and methods

Table of Contents
4.1. Subjects
4.2. Methods

4.1. Subjects

The study was carried out in the Departments of Neurology, Clinical Neurophysiology, Radiology and division of Cardiology, University of Oulu during the years 1994-2003. The study was approved by the Ethics committee of the Medical Faculty of University of Oulu and carried out according to the principles of the Declaration of Helsinki. All patients and control subjects gave their informed consent before their inclusion in the study. 128 patients seen in the outpatient clinic of the Department of Neurology, Oulu University Hospital were included in the study. Manifestations of illness any other than epilepsy (e.g. diabetes mellitus, cardiopulmonary diseases, alcoholism, or renal failure) or medication known to affect the ANS were used as exclusion criteria. Similarly female patients who were pregnant or lactating were excluded. The clinical characteristics of the patients and control subjects in the individual studies are presented in Tables 6 and 7. In Table 8 (page 58) the number of patients with various types of epilepsy in different substudies participating in various examinations is shown.

Eighty four epilepsy patients participated in study I. Sixty patients had partial epilepsy whereas 24 patients suffered from idiopathic generalized epilepsies. Thirty-seven were previously untreated patients referred to the Outpatient Clinic for diagnosis and treatment because of experiencing at least two epileptic seizures. Fourty seven patients were already diagnosed with epilepsy. Of these, 29 patients had been seizure-free for at least one year before the study and 18 patients had recurrent seizures. However, all 47 patients had been seizure-free at least one week before the study.

Thirty-eight patients with TLE participated in study II. Nineteen patients had well controlled TLE and most of them had been seizure free since starting antiepileptic medication. Nineteen patients had refractory TLE and suffered from recurrent monthly seizures despite the regular use of AEDs.

Fourty four TLE patients participated in study III. Of these, 25 patients had well controlled TLE, and 19 patients had refractory TLE.

Thirty nine patients with TLE participated in study IV. Of these patients 8 had hippocampal sclerosis and 31 had normal imaging of the brain.

The control population consisted of 84 healthy age and sex matched subjects who were members of the hospital staff, people recruited by the members of the hospital staff or healthy persons randomly selected by social code from the general population of Oulu. None of them had symptoms or signs of disease or medication affecting the ANS in their medical history and they had normal bodyweight.

Table 6. The demographics of the study patients and the control subjects.

StudiesMale/Female/TotalAgeDuration of epilepsyNumber of patients by the type of epilepsy
(years ± SD)P/GE
Study I
Untreated23/14/3731 ± 10-24/13
Patients taking AED(s)31/16/4731 ± 812 ± 936/11
Control subjects33/17/5039 ± 29--/-
Study II
Patients with refractory TLE4/15/1933 ± 722 ± 1119/-
Patients with well controlled TLE4/15/1934 ± 714 ± 1019/-
Control subjects8/30/3833 ± 8--/-
Study III
Patients with refractory TLE5/14/1933 ± 722 ± 1019/-
Patients with well controlled TLE11/14/2533 ± 616 ± 1025/-
Control subjects9/25/3433 ± 10--/-
Study IV
Patients with HS2/6/836 ± 527 ± 108/-
Patients without HS11/20/3131 ± 716 ± 931/-
Control Subejcts12/50/7234 ± 8--/-
P, partial epilepsy; GE, idiopathic generalized epilepsies; HS, hippocampal sclerosis.

Table 7. The antiepileptic medication of the study patients

AED(s)Study I P/GEStudy II rTLE/wTLEStudy III rTLE/wTLEStudy IV HS/No-HS
CBZ17/2 -/9 -/14 3/8
OXC-/- 5/8 4/8 -/11
PHT9/1 -/1 -/1 -/1
VPA-/6 1/- 1/- -/-
LTG-/- -/1 -/1 -/1
CBZ with other AED(s)2/2 6/- 7/1 3/5
OXC with other AED(s)-/- 6/- 7/- 2/5
P, partial epilepsy; GE, idiopathic generalized epilepsies; rTLE, refractory temporal lobe epilepsy; wTLE, well controlled temporal lobe epilepsy; HS, hippocampal sclerosis; No-HS, no hippocampal sclerosis; CBZ, carbazepine; OXC, oxcarbazepine; PHT, phenytoin; VPA, valproate; LTG, lamotrigine.