Actively Recruiting

Phase Not Applicable
Age: 16Years +
All Genders
NCT05609084

Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy

Led by Assistance Publique Hopitaux De Marseille · Updated on 2024-07-18

214

Participants Needed

12

Research Sites

243 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient 16 years of age and older
  • Epileptogenic area involves temporal structures of the language-specialized hemisphere
  • Known hemispheric specialization for language
  • Planned resective surgery in temporal lobe compatible with study schedule
  • Known neuropsychological test (NTB) score
  • Signed informed consent by patient or legal guardian
  • First language is French
  • Familiar with computer use and has home internet access
  • Affiliated with or benefiting from a social security system
Not Eligible

You will not qualify if you...

  • Speech disorder impairing intelligibility and use of the interface
  • Uncorrected hearing impairment
  • Total IQ below 70 measured within the year before surgery
  • Pregnant or nursing
  • Deprived of liberty or under guardianship or curatorship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 12 locations

1

Service EFSN - Hôpital Pellegrin

Bordeaux, France

Actively Recruiting

2

Service de Neurologie de l'Epilepsie - CHU Grenoble-Alpes

Grenoble, France

Actively Recruiting

3

Département de Neurophysiologie Clinique - Hôpital Roger Salengro - CHU Lille

Lille, France

Actively Recruiting

4

Hôpital Neurologique Pierre Wertheimer- Service de Neurologie Fonctionnelle et Epileptologie - Hospices Civils Lyon

Lyon, France

Not Yet Recruiting

5

Service Epilptologie et Rythmologie Cérébrale

Marseille, France

Actively Recruiting

6

Service de Neurologie - Hôpital central -CHU Nancy

Nancy, France

Not Yet Recruiting

7

Département de Neurologie - Hôpital de la Pitié-Salpêtrière - APHP

Paris, France

Not Yet Recruiting

8

Service de Neurochirurgie -GHU Sainte-Anne

Paris, France

Not Yet Recruiting

9

Service de Neurologie - Fondation ophtalmologique de Rothschild - Fondation Rothschild

Paris, France

Actively Recruiting

10

Service de Neurologie - CHU de Rennes

Rennes, France

Not Yet Recruiting

11

Service de Neurologie - Hôpitaux Universitaires, Hôpital de Hautepierre

Strasbourg, France

Actively Recruiting

12

Explorations Neurophysiologiques, Pôle des Neurosciences - Hôpital Pierre Paul Riquet, Purpan

Toulouse, France

Not Yet Recruiting

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Research Team

V

Veronique Sabadell

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy | DecenTrialz