Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT04939675 |
| Other study ID # |
202104076MINA |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 1, 2021 |
| Est. completion date |
June 30, 2025 |
Study information
| Verified date |
June 2021 |
| Source |
National Taiwan University Hospital |
| Contact |
Kai-Chieh Chang, M.D. |
| Phone |
+886-972652523 |
| Email |
b94401022[@]ntu.edu.tw |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Atypical presentations in epilepsy may include confusion status, acute maniac or delirious
condition, loss of cognitive ability such as speech, interaction skills, or other praxis.
Current diagnosis of epilepsy did not address on definition of seizure. The new insights of
seizure semiology and their treatment response, suggest the screen tool and diagnostic
criteria of epilepsy can be revised.
In this study, we have two aims. The first aim is to develop a screening questionnaire by
adding new semiology of epilepsy, including abnormality in psychiatry, cognition, and sleep,
and to test its accuracy. The second aim is to evaluate the benefits in cognition of
anti-epileptic drug intervention in participants with positive screening results.
Description:
The age-adjusted prevalence and incidence of epilepsy were 5.85 (per 1,000) and 97 (per
100,000 person-years) in Taiwan according to a database survey from National Health
Insurance. In community screen of 13,663 subjects aged 30 years or older in Keelung, 52
patients were found with epilepsy, which corresponded to a 2.77/1000 of prevalence rate. Of
those patients, 24.3% had never been diagnosed before.
The screening of epilepsy was based on questionnaires, including questions inquiring whether
the patients have motor manifestation of epilepsy, including motor convulsion, twitching
(myoclonus), behavior arrest, sudden falling, loss of consciousness, or known diagnosis of
epilepsy. Recently, literature has reported atypical initial presentation of epilepsy such as
rapid cognitive decline and mood disturbance. A study of patients with severe psychiatric
disorders has also found that 1.6% cases had undiagnosed epilepsy, which was higher than that
in general population. Atypical presentations in epilepsy may include confusion status, acute
maniac or delirious condition, loss of cognitive ability such as speech, interaction skills,
or other praxis. Additionally, vomiting, terrors, or hyperkinetic movements during sleep may
also be observed in patients with epilepsy. Indeed, the International League Against Epilepsy
has included cognitive, emotional, and sensory as non-motor onset presentations in its new
classification.
The diagnosis of epilepsy was based on any at least two unprovoked (or reflex) seizures
occurring >24 h apart. However, the diagnosis did not address on definition of seizure.
Anti-seizure medications (ASMs) had been reported to improve cognitive performance in the
older people with cognitive impairment and epileptiform discharge on electroencephalography.
There was also a report of recovery of long-term anterograde amnesia after initiation of an
ASM in a case of transient epileptic amnesia. The new insights of seizure semiology and their
treatment response, suggest the screen tool and diagnostic criteria of epilepsy can be
revised.
In this study, we have two aims. The first aim is to develop a screening questionnaire by
adding new semiology of epilepsy, including abnormality in psychiatry, cognition, and sleep,
and to test its accuracy. We used the 9-question screening questionnaire as a backbone.
Additional questions included Q10: sleep events including sleep-onset vomiting, night scare,
or hyperkinetic movement paroxysmal cognitive events (Q11: any paroxysmal agitation or
confusion; Q12: any paroxysmal function loss, including communication, praxis, or other
mental function); rapid progressive events (Q13: rapid progressive cognitive decline; Q14:
recent hallucination, delusion, change in mood and behaviors). The questionnaire will then be
translated into traditional Chinese version by a bilingual qualified neurologist. The
translated version will then back-translated into English by an independent bilingual
researcher and will finally be determined by a group of experts in neuropathy, pain, and
linguistics.
The second aim is to evaluate the benefits in cognition of anti-epileptic drug intervention
in participants with positive screening results. After excluding participants with diagnosis
of epilepsy per criteria as above, participants are recruited to the antiepileptic drug trial
if they fulfill positive responses in Q11-Q14 of the questionnaire or the Mini-Mental State
Examination (MMSE) ≦ 24, and presence of epileptiform discharge in electroencephalography
(EEG), including spikes, sharp waves, temporal intermittent rhythmic delta activity, or other
focal or generalized slow waves that could not be explained by physiological or anatomical
pathology. Participants who fulfill criteria will be included in this open-labeled randomized
study to test efficacy of anti-seizure medication (ASM) in these patients.
