EpilepsyNCT02854384
Mobile Phone Radiation and Brain Rhythm in Epileptic Patients
An observational study of Epilepsy, run by Kasr El Aini Hospital.
Trial summary
This work is intended to assess the effect of -30 minutes- exposure to mobile-phone on the functions of the central nervous system (CNS) in epileptic patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Sep 2015
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This study included 30 epileptic patients and 30 healthy volunteers, males and females whose age above 18 years.
Who may be able to join
- Both sexes
- Above 18 years
- Epileptic patients (regardless of whether symptomatic, idiopathic, focal or generalized)
Who cannot join
- Age less than 18 years
- Chronic medical condition
- Epileptic fit in the last 48 hours
About this study
This work is intended to assess the effect of -30 minutes- exposure to mobile-phone on the functions of the central nervous system (CNS) in epileptic patients.
Read the detailed description
This work shows the effect of the 30 minutes mobile waves' radiation over the normal person brain activity (EEG) and cognition (P300) together with the effect over the unstable brain of the epileptic patients. Exposure to mobile-phone radiation has been reported to increase the spectral power of electroencephalograms (EEGs), particularly in the alpha band, during both the waking and sleeping states. The tendency toward electrical instability of the neural networks of epileptic patients suggests that these individuals may be especially sensitive to electromagnetic fields espcially mobile-phone radiation (MPR). The short-term effects of exposure to electromagnetic (EM) fields on a number of cognitive variables such as memory, attention and speed of decision-making could be assedsed by P 300 latency and amplitude.
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Mobile phone
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Epilepsy Patients | males and females whose age more than 18 years, diagnosed with epilepsy, regardless of whether symptomatic,idiopathic ,focal or generalized | |
| Healthy Control | males and females whose age more than 18 years |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Electroencephalography (EEG) examination
Measured: one day
P300 test
The P300 Test: Neurophysiological Test. P300 wave was defined as the most positive point of the average waveform to the target tones after 250 msec and before 600 msec. For each subject P300 latency and P300 amplitude were obtained to detect any significant abnormality
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha El Sawy, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854384
- Sponsor's protocol ID
- 1
- Status last verified
- Aug 2016
- First submitted
- 31 Jul 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Phone Radiation and Brain Rhythm in Epileptic Patients
- ClinicalTrials.gov ID
- NCT02854384
- Acronym / sponsor ID
- 1
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Mobile phone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 3 Aug 2016 (estimated)
- 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.
This work is intended to assess the effect of -30 minutes- exposure to mobile-phone on the functions of the central nervous system (CNS) in epileptic patients.
Detailed description
This work shows the effect of the 30 minutes mobile waves' radiation over the normal person brain activity (EEG) and cognition (P300) together with the effect over the unstable brain of the epileptic patients. Exposure to mobile-phone radiation has been reported to increase the spectral power of electroencephalograms (EEGs), particularly in the alpha band, during both the waking and sleeping states. The tendency toward electrical instability of the neural networks of epileptic patients suggests that these individuals may be especially sensitive to electromagnetic fields espcially mobile-phone radiation (MPR). The short-term effects of exposure to electromagnetic (EM) fields on a number of cognitive variables such as memory, attention and speed of decision-making could be assedsed by P 300 latency and amplitude.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Epilepsy Patients | – | –males and females whose age more than 18 years, diagnosed with epilepsy, regardless of whether symptomatic,idiopathic ,focal or generalized |
| Healthy Control | – | –males and females whose age more than 18 years |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This study included 30 epileptic patients and 30 healthy volunteers, males and females whose age above 18 years.
Key inclusion criteria (3 listed)
- Both sexes
- Above 18 years
- Epileptic patients (regardless of whether symptomatic, idiopathic, focal or generalized)
Key exclusion criteria (3 listed)
- Age less than 18 years
- Chronic medical condition
- Epileptic fit in the last 48 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Digital Electroencephalography (EEG) examination
Time frame: one day
P300 test
Time frame: one day
The P300 Test: Neurophysiological Test. P300 wave was defined as the most positive point of the average waveform to the target tones after 250 msec and before 600 msec. For each subject P300 latency and P300 amplitude were obtained to detect any significant abnormality
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Epilepsy, run by Kasr El Aini Hospital.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 4 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Digital Electroencephalography (EEG) examination (time frame: one day). The study lists 2 primary outcomes in all. 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 4 Aug 2016.