MigraineNCT02854930
Near Death Experience (NDE) and Migraine
An observational study of Migraine and Near Death Experience, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Migraine is a common disabling primary headache disorder. Epidemiological studies have documented its high prevalence and high socio-economic and personal impacts. Migraine affects more than 20% of the French population. However, the physiopathology of migraine is always partially known. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Migraine, Near Death Experience
- What is being tested?
- questioning
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2017to Mar 2018
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: subject who experienced a near death experience (NDE).
Who may be able to join
- Subject who experienced an NDE defined by the occurrence, when the subject is in a state of clinical death or a particular state of consciousness of a following event: body output experience, disembodiment, for a tunnel and / or light;
- Topic recorded in the EMI database (Dr. Postel, National Center for Education, Research and Information on the conscience;
- Topic agreeing to participate in the study.
Who cannot join
- Patient mental condition or disorder or psychiatric history or any other factor limiting the ability to participate in an informed manner and compliant to the study;
- Other than obtained Participation Agreement.
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Marseille Hôpital de la Timone
Marseille, 13354
Anne Donnet, 0491382747, drci@ap-hm.fr
About this study
Migraine is a common disabling primary headache disorder. Epidemiological studies have documented its high prevalence and high socio-economic and personal impacts. Migraine affects more than 20% of the French population. However, the physiopathology of migraine is always partially known. Cortical spreading depression (CSD) is the widely accepted as the electrophysiologic substrate of migraine aura. CSD is a slowly propagating wave of transient neuronal and glial depolarization. The near death experience (NDE) is a rare, but well known phenomenon. NDE are profound psychic experiences commonly occuring in life-threatening conditions. Among the neurological hypotheses, epilepsy, temporal lobe disorders , REM-sleep intrusion have been discussed. However, the role of DCE has never been discussed. The goals of this study are : to see if there is an epidemiological link between NDE and migraine/ to specify if NDE was followed by a migrainous headache.
- Conditions
- Migraine, Near Death Experience
- Being tested
- questioning
- Keywords
- Clinical death, state of consciousness
- Medical subject headings
- Migraine Disorders, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questioningOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
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 posted4 Aug 2016 (estimated)
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Observational
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle Desalbres, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854930
- Sponsor's protocol ID
- 2014-47
- Status last verified
- Aug 2016
- First submitted
- 1 Aug 2016
- Last updated
- 4 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
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
- Near Death Experience (NDE) and Migraine
- ClinicalTrials.gov ID
- NCT02854930
- Acronym / sponsor ID
- 2014-47
- Conditions
- Migraine, Near Death Experience
- Keywords
- Clinical death, state of consciousness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 4 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.
Migraine is a common disabling primary headache disorder. Epidemiological studies have documented its high prevalence and high socio-economic and personal impacts. Migraine affects more than 20% of the French population. However, the physiopathology of migraine is always partially known. Cortical spreading depression (CSD) is the widely accepted as the electrophysiologic substrate of migraine aura. CSD is a slowly propagating wave of transient neuronal and glial depolarization. The near death experience (NDE) is a rare, but well known phenomenon. NDE are profound psychic experiences commonly occuring in life-threatening conditions. Among the neurological hypotheses, epilepsy, temporal lobe disorders , REM-sleep intrusion have been discussed. However, the role of DCE has never been discussed. The goals of this study are : to see if there is an epidemiological link between NDE and migraine/ to specify if NDE was followed by a migrainous headache.
Study design
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- subject who experienced a near death experience (NDE).
Key inclusion criteria (3 listed)
- Subject who experienced an NDE defined by the occurrence, when the subject is in a state of clinical death or a particular state of consciousness of a following event: body output experience, disembodiment, for a tunnel and / or light;
- Topic recorded in the EMI database (Dr. Postel, National Center for Education, Research and Information on the conscience;
- Topic agreeing to participate in the study.
Key exclusion criteria (2 listed)
- Patient mental condition or disorder or psychiatric history or any other factor limiting the ability to participate in an informed manner and compliant to the study;
- Other than obtained Participation Agreement.
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 |
|---|---|---|
| questioning | Other | – |
Primary outcome
Quality of life
Time frame: one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2016.
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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.
Urielle Desalbres study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine and Near Death Experience, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 2 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 4 Aug 2016. 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 France. 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. 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 Anne Donnet (0491382747, drci@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: one day). 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.