Cognitive ImpairmentNCT05068323
Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients
A study testing Digital electroencephalography (EEG) for an hour (16 channels) in people with Cognitive Impairment and Epilepsy, run by Assiut University at 1 site in Egypt.
Trial summary
Epilepsy is a common health problem worldwide. In general population, studies in developed countries estimated the annual incidence of epilepsy to be~50 per 100,000 and prevalence to be ~8.2 per 1,000. These figures are higher in developing countries in which prevalence of >10 per 1,000 was reported. Read more about this study
- Who is it for?
- Ages 10 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Impairment, Epilepsy
- What is being tested?
- Digital electroencephalography (EEG) for an hour (16 channels)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- a) Patients [with age ranges from 10 to 50 years] of both sex. b) Patients with confirmed diagnosis of idiopathic localization-related or generalized epilepsy.
- Either before receiving anti-epileptic drugs or on regular treatment with antiepileptic drugs for less three months.
Who cannot join
- Patients with symptomatic or secondary epilepsies either due to general medical conditions or drug induced.
- Other neurological , psychiatric or metabolic disorders that affect cognition.
- Regular use of antiepileptic medications more than three months.
- utilization of regular medications other than AEDs that affect cognition.
Trial locations and contacts
1 site in 1 country.
About this study
Epilepsy is a common health problem worldwide. In general population, studies in developed countries estimated the annual incidence of epilepsy to be~50 per 100,000 and prevalence to be ~8.2 per 1,000. These figures are higher in developing countries in which prevalence of >10 per 1,000 was reported. In Upper Egypt, Assiut Governorate, the prevalence rate was 12.9 per 1,000.
In people with epilepsy there is an associated high rate of cognitive difficulties that compromise educational progress and achievement throughout life. Approximately 1-5% of the population exhibits epileptiform discharges on electroencephalography (EEG). Interictal epileptiform discharges (IEDs), meaning spikes, polyspikes, sharp waves, or spike and slow-wave complexes without observed clinical seizures, are commonly observed in patients with epilepsy.
Read more
Epilepsy syndromes manifesting with IEDs are detrimental to cognitive function. Recently, two studies found that frequent IEDs can impair cognitive performance in children. and adult patients. Several studies indicated that IEDs in patients with epilepsy had a disruptive effect on information processing speed with even a low percentage of IEDs (1%).However, it is unclear whether IEDs are associated with disrupted academic performance in patients with idiopathic epilepsy, and the relationship between general cognitive ability and academic performance in those patients has not been clarified.
Understanding how IEDs interfere with neurocognitive outcomes is important ,while the goal of medical and surgical treatments for epilepsy is to achieve seizure-freedom with minimal morbidity, the benefits of IED suppression are more controversial.
Read the detailed description
This study aims to
- Evaluate the influence of interictal epileptiform activity per se on some cognitive functions in newly diagnosed patients with epilepsy (before using anti-seizure medications)
- Determine different effects among different brain areas (producing epileptiform activity) on specific cognitive domains Type of the study: Case control Study Study Setting: Assiut university hospital -Neuropsychiatry hospital- Out patient clinics.
Study subjects: Will include epilepsy patients that diagnosed according to the International League Against Epilepsy criteria, 2017:
Study tools All patients included in this study will be subjected to: -
- History taking including Personal history, history of present illness, therapeutic history, past history and family history
- Complete physical examination. 3) Neurological examination. 4) Digital electroencephalography (EEG) for an hour (16 channels). 5) Psychiatric assessment: all subjects included in the study will be asked to perform a series of psychological tests done by expert psychologist to detect cognitive impairment
- Montreal Cognitive Assessment(MoCA).
- Hamilton Depression Rating Scale (HDRS).
- Conditions
- Cognitive Impairment, Epilepsy
- Being tested
- Digital electroencephalography (EEG) for an hour (16 channels)
- Medical subject headings
- Cognitive Dysfunction, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital electroencephalography (EEG) for an hour (16 channels)Diagnostic test
Digital electroencephalography (EEG) for an hour (16 channels)
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy | Other | Newly diagnosed epileptic patients Receives: Diagnostic Test: Digital electroencephalography (EEG) for an hour (16 channels) |
| Control | Sham comparator | healthy subjects Receives: Diagnostic Test: Digital electroencephalography (EEG) for an hour (16 channels) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the effect of some High frequency epileptiform discharges measured by HZ on some cognitive domines using electroencephalogram
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2021
- Study start30 Sep 2021 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- case control
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shady Mohamed Safwat Hassan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068323
- Sponsor's protocol ID
- Epilepsy and Cognition
- Status last verified
- Oct 2021
- First submitted
- 20 Sep 2021
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients
- ClinicalTrials.gov ID
- NCT05068323
- Acronym / sponsor ID
- Epilepsy and Cognition
- Conditions
- Cognitive Impairment, Epilepsy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Sep 2021 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Jun 2022 (estimated)
- First posted
- 5 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Epilepsy is a common health problem worldwide. In general population, studies in developed countries estimated the annual incidence of epilepsy to be~50 per 100,000 and prevalence to be ~8.2 per 1,000. These figures are higher in developing countries in which prevalence of >10 per 1,000 was reported. In Upper Egypt, Assiut Governorate, the prevalence rate was 12.9 per 1,000.
In people with epilepsy there is an associated high rate of cognitive difficulties that compromise educational progress and achievement throughout life. Approximately 1-5% of the population exhibits epileptiform discharges on electroencephalography (EEG). Interictal epileptiform discharges (IEDs), meaning spikes, polyspikes, sharp waves, or spike and slow-wave complexes without observed clinical seizures, are commonly observed in patients with epilepsy.
Epilepsy syndromes manifesting with IEDs are detrimental to cognitive function. Recently, two studies found that frequent IEDs can impair cognitive performance in children. and adult patients. Several studies indicated that IEDs in patients with epilepsy had a disruptive effect on information processing speed with even a low percentage of IEDs (1%).However, it is unclear whether IEDs are associated with disrupted academic performance in patients with idiopathic epilepsy, and the relationship between general cognitive ability and academic performance in those patients has not been clarified.
Understanding how IEDs interfere with neurocognitive outcomes is important ,while the goal of medical and surgical treatments for epilepsy is to achieve seizure-freedom with minimal morbidity, the benefits of IED suppression are more controversial.
Detailed description
This study aims to
- Evaluate the influence of interictal epileptiform activity per se on some cognitive functions in newly diagnosed patients with epilepsy (before using anti-seizure medications)
- Determine different effects among different brain areas (producing epileptiform activity) on specific cognitive domains Type of the study: Case control Study Study Setting: Assiut university hospital -Neuropsychiatry hospital- Out patient clinics.
Study subjects: Will include epilepsy patients that diagnosed according to the International League Against Epilepsy criteria, 2017:
Study tools All patients included in this study will be subjected to: -
- History taking including Personal history, history of present illness, therapeutic history, past history and family history
- Complete physical examination. 3) Neurological examination. 4) Digital electroencephalography (EEG) for an hour (16 channels). 5) Psychiatric assessment: all subjects included in the study will be asked to perform a series of psychological tests done by expert psychologist to detect cognitive impairment
- Montreal Cognitive Assessment(MoCA).
- Hamilton Depression Rating Scale (HDRS).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- case control
| Arm | Type | Receives |
|---|---|---|
| Epilepsy | Other | Diagnostic Test: Digital electroencephalography (EEG) for an hour (16 channels)Newly diagnosed epileptic patients |
| Control | Sham comparator | Diagnostic Test: Digital electroencephalography (EEG) for an hour (16 channels)healthy subjects |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- a) Patients [with age ranges from 10 to 50 years] of both sex. b) Patients with confirmed diagnosis of idiopathic localization-related or generalized epilepsy.
- Either before receiving anti-epileptic drugs or on regular treatment with antiepileptic drugs for less three months.
Key exclusion criteria (4 listed)
- Patients with symptomatic or secondary epilepsies either due to general medical conditions or drug induced.
- Other neurological , psychiatric or metabolic disorders that affect cognition.
- Regular use of antiepileptic medications more than three months.
- utilization of regular medications other than AEDs that affect cognition.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Digital electroencephalography (EEG) for an hour (16 channels)Digital electroencephalography (EEG) for an hour (16 channels) | Diagnostic test | Control, Epilepsy |
Primary outcome
Evaluate the effect of some High frequency epileptiform discharges measured by HZ on some cognitive domines using electroencephalogram
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital electroencephalography (EEG) for an hour (16 channels) in people with Cognitive Impairment and Epilepsy, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shady Mohamed Safwat Mohamed T Hassan, MD (00201008763141, Shady.hassan@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the effect of some High frequency epileptiform discharges measured by HZ on some cognitive domines using electroencephalogram (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2021; AzTrials last refreshed its copy on 7 Nov 2026.