NCT05609084Recruiting
Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy
Source: ClinicalTrials.gov · Last updated 18 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Out of 30,000 new cases per year in France, 30% of epileptic patients are drug-resistant. Neurosurgery, which consists in resecting the epileptogenic zone, is the only chance of cure. In the case of temporal epilepsy of the language-dominant hemisphere (TLE), this procedure presents a high risk of increasing cognitive difficulties and may even be contraindicated for this reason alone. The difficulties found are impairments in lexical access (anomia) and verbal memory and affect more than 60% of patients . Preoperative cognitive rehabilitation could influence brain plasticity mechanisms but there are currently no recommendations on this topic. In this context, the investigators have developed a speech rehabilitation procedure specific to the needs of ELTPR patients. They rely on cognitive hypotheses explaining the disorders but also on models of rehabilitation-induced neural plasticity likely to improve cognitive reserve before surgery. The investigators hypothesize that preoperative cognitive language rehabilitation in ELTPR patients may decrease surgical risk and improve postoperative language prognosis. The primary objective is to demonstrate the protective efficacy of preoperative speech rehabilitation on language performance postoperatively.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 214 (estimated)
- First submitted
- 25 Oct 2022
- Start date
- 30 Mar 2023
- Primary completion date
- 30 Mar 2027
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Diseases
- Epilepsy
- NCT number
- NCT05609084
What you commit to
- Study type: Interventional
- Planned participants: 214
- From 30 Mar 2023 to the primary completion date, 30 Mar 2027
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with a total intelligence quotient (IQ) \<70 (assessed in the context of care, in the year preceding the surgical procedure)
Other illness
- Patient with a speech disorder that may impair intelligibility and compromise the use of the interface;
- Patient with an uncorrected hearing impairment,
Other
- Patients who are pregnant, nursing, deprived of liberty, under guardianship or curatorship.
Who the study is looking for
- Patient 16 years of age and older,
- Patient whose epileptogenic area involves the temporal structures of the hemisphere specialized for language,
- Patient whose hemispheric specialization for language is known
- Patient willing to undergo resective surgery such as anterior temporal lobectomy or resection in the temporal lobe involving the hippocampus and/or the baso-temporal language area and whose planned surgery date is compatible with the performance of the study,
- Patient with a known NTB score
- Patient who has signed an informed consent or patient whose parents or legal guardians have signed the informed consent (or a single parent or legal guardian if applicable)
- Patient whose first language is French (1st language learned by the patient),
- Patient declaring to be familiar with the use of a computer and having access to an internet connection from home
- Patient affiliated or benefiting from a social security system.
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Service EFSN - Hôpital Pellegrin Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Service de Neurologie de l'Epilepsie - CHU Grenoble-Alpes Coordinator of this site? Confirm its status | Grenoble | France | Recruiting |
| Département de Neurophysiologie Clinique - Hôpital Roger Salengro - CHU Lille Coordinator of this site? Confirm its status | Lille | France | Recruiting |
| Hôpital Neurologique Pierre Wertheimer- Service de Neurologie Fonctionnelle et Epileptologie - Hospices Civils Lyon Coordinator of this site? Confirm its status | Lyon | France | Not yet recruiting |
| Service Epilptologie et Rythmologie Cérébrale Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| Service de Neurologie - Hôpital central -CHU Nancy Coordinator of this site? Confirm its status | Nancy | France | Not yet recruiting |
| Département de Neurologie - Hôpital de la Pitié-Salpêtrière - APHP Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Service de Neurologie - Fondation ophtalmologique de Rothschild - Fondation Rothschild Coordinator of this site? Confirm its status | Paris | France | Recruiting |
| Service de Neurochirurgie -GHU Sainte-Anne Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Service de Neurologie - CHU de Rennes Coordinator of this site? Confirm its status | Rennes | France | Not yet recruiting |
| Service de Neurologie - Hôpitaux Universitaires, Hôpital de Hautepierre Coordinator of this site? Confirm its status | Strasbourg | France | Recruiting |
| Explorations Neurophysiologiques, Pôle des Neurosciences - Hôpital Pierre Paul Riquet, Purpan Coordinator of this site? Confirm its status | Toulouse | France | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.