Epilepsy, Unspecified, Pharmacologically ResistantMemO-EpiNCT01919957
Episodic Memory Before and After Surgery in Drug-resistant Partial Epilepsies
An observational study of Epilepsy, Unspecified, Pharmacologically Resistant and Memory Impairment, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
This study has two purposes: firstly, a better understanding of the neurobiological processes underlying episodic memory and, secondly, the development of useful clinical applications for epileptic patients, in particular the prediction of postoperative memory deficits and the development of cognitive remediation… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Epilepsy, Unspecified, Pharmacologically Resistant, Memory Impairment
- How many people
- 29 participants
- Where
- 1 siteFrance
- Study dates
- 10 Oct 2013to 9 Oct 2022
- Phase
- Observational
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: The research requires the inclusion of healthy volunteers (controls) and epileptic patients
Who may be able to join
- Patients with drug-resistant epilepsy
- Age of 18 years or more
- Follow-up in the epilepsy unit at Pitié-Salpêtrière Hospital
- Before or after the presurgical evaluation unit including a video-EEG monitoring, a structural brain imaging and a full neuropsychological assessment
- Covered by a social security system
- Signing of consent form
Who cannot join
- Persons under guardianship, curatorship or any other administrative or judicial deprivation of rights and freedom
- Refusal to consent form
- Contraindications to MRI
- Pregnancy
- Refusal to be informed in the case of detection of an abnormality during the experiment
Trial locations and contacts
1 site in 1 country.
France1 site
INSERM - Plateau IRM du CENIR, CR-ICM Hôpital Pitié-Salpêtrière, 47/83 Boulevard de l'Hôpital
Paris, 75651 Cedex 13
About this study
Official title: Etude de la mémoire Avant et après Chirurgie d'Une épilepsie Partielle pharmacorésistante : Bases Neurobiologiques, Applications Cliniques
This study has two purposes: firstly, a better understanding of the neurobiological processes underlying episodic memory and, secondly, the development of useful clinical applications for epileptic patients, in particular the prediction of postoperative memory deficits and the development of cognitive remediation therapies.
Memory performances during a fMRI experiment will be assessed in controls and epileptic patients before and after the surgery.
- Keywords
- epilepsy, surgery, functional MRI, memory outcome
- Medical subject headings
- Epilepsy, Memory Disorders
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 |
|---|---|---|
| memory outcome | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure of successfull encoding
Our goal is to define correlation between the measure of successfull object encoding trials (especially for binding) and the beta value activation in fMRI
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2013 (estimated)
- Study start10 Oct 2013
- Primary completion9 Oct 2021
- Study completion9 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epilepsy, Unspecified, Pharmacologically ResistantStudies of the same condition, open and under way.
- More trials run by Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sophie Dupont, MD, PhD, Principal investigator, Service de Soins de Suites et Réadaptation Neurologique, Hôpital de la Pitié-Salpêtrière, 47/83 Bd de l'Hôpital, 75651 Paris Cedex 13
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01919957
- Sponsor's protocol ID
- C12-11
- Other IDs
- 2013-A00343-42
- Acronym
- MemO-Epi
- Status last verified
- Apr 2025
- First submitted
- 1 Jul 2013
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No