Stability of EEG Features in HumansNCT02254213
Intra-individual Stability in Electroencephalography (EEG) Parameters
An observational study of Stability of EEG Features in Humans, run by Mentis Cura.
Trial summary
The main objective is to evaluate the stability of EEG features on an individual level. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Stability of EEG Features in Humans
- What is being tested?
- EEG recording
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- Jun 2005to Aug 2007
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 15 individuals in the age range of 50 - 90 years.
Who may be able to join
- Age must be in the range 50 - 90 years
Who cannot join
- Outside required age range
About this study
Official title: Intra-individual Stability in EEG Parameters
The main objective is to evaluate the stability of EEG features on an individual level.
- Conditions
- Stability of EEG Features in Humans
- Being tested
- EEG recording
- Keywords
- Intra-individual stability, EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EEG recordingOther
A short EEG recording is performed 10 times over the span of three months.
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative EEG (qEEG) features
qEEG features are extracted from 10 separate EEG recordings from each individual in the cohort.
Measured: Three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2014 (estimated)
- Study startJun 2005
- Primary completionAug 2005
- Study completionAug 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stability of EEG Features in HumansStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mentis Cura
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Icelandic Research Center
- Responsible party
- Sponsor
- Investigators
- Kristinn Johnsen, PhD, Principal investigator, Mentis Cura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02254213
- Sponsor's protocol ID
- MC-CT-003
- Status last verified
- Sep 2014
- First submitted
- 29 Sep 2014
- Last updated
- 1 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Gudmundsson S, Runarsson TP, Sigurdsson S, Eiriksdottir G, Johnsen K. Reliability of quantitative EEG features. Clin Neurophysiol. 2007 Oct;118(10):2162-71. doi: 10.1016/j.clinph.2007.06.018. Epub 2007 Aug 31.
PubMed 17765604
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-individual Stability in EEG Parameters
- ClinicalTrials.gov ID
- NCT02254213
- Acronym / sponsor ID
- MC-CT-003
- Conditions
- Stability of EEG Features in Humans
- Keywords
- Intra-individual stability, EEG
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Mentis CuraIndustry (pharma, biotech, devices)
- Collaborators
- Icelandic Research Center
- Study start
- Jun 2005
- Primary completion
- Aug 2005 (actual)
- Study completion
- Aug 2007 (actual)
- First posted
- 1 Oct 2014 (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.
The main objective is to evaluate the stability of EEG features on an individual level.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 15 individuals in the age range of 50 - 90 years.
Key inclusion criteria (1 listed)
- Age must be in the range 50 - 90 years
Key exclusion criteria (1 listed)
- Outside required age range
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 |
|---|---|---|
| EEG recordingA short EEG recording is performed 10 times over the span of three months. | Other | – |
Primary outcome
Quantitative EEG (qEEG) features
Time frame: Three months
qEEG features are extracted from 10 separate EEG recordings from each individual in the cohort.
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 1 Oct 2014.
- Results publication: PubMed 17765604Gudmundsson S, Runarsson TP, Sigurdsson S, Eiriksdottir G, Johnsen K. Reliability of quantitative EEG features. Clin Neurophysiol. 2007 Oct;118(10):2162-71. doi: 10.1016/j.clinph.2007.06.018. Epub 2007 Aug 31.
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.
Kristinn Johnsen, PhD principal investigator
Mentis Cura
Questions about this trial
What is this clinical trial studying?
An observational study of Stability of EEG Features in Humans, run by Mentis Cura.
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 1 inclusion and 1 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 1 Oct 2014. 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?
Quantitative EEG (qEEG) features (time frame: Three months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02254213, which also lists 1 linked publication.
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 1 Oct 2014.