NCT05609084

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Mar 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

12 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress67%
Mar 2023Nov 2027

First Submitted

Initial submission to the registry

October 25, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

November 8, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

March 30, 2023

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2027

Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

4 years

First QC Date

October 25, 2022

Last Update Submit

July 17, 2024

Conditions

EpilepsyAnomiaTemporal Lobe Epilepsy

Outcome Measures

Primary Outcomes (1)

  • Effect of rehabilitation on immediate postoperative performances

    Number of images quoted

    Day 7 after surgery

Secondary Outcomes (14)

  • Impact of rehabilitation on long-term postoperative performance

    6 months after surgery

  • Impact of rehabilitation on immediate on standardized language tests

    Day 7 after surgery

  • Impact of rehabilitation on long-term postoperative performance on standardized language tests

    6 months after surgery

  • Impact of preoperative rehabilitation on verbal memory

    Day 7 after surgery

  • Impact of preoperative rehabilitation on verbal memory

    6 months after surgery

  • +9 more secondary outcomes

Study Arms (2)

Control

OTHER

Patients will have speech therapy assessment in addition to standard care.

Procedure: Speech therapy assessment

Experimental

EXPERIMENTAL

Patients will have speech therapy assessment and intensive speech rehabilitation

Procedure: Speech therapyProcedure: Speech therapy assessment

Interventions

Speech therapyPROCEDURE

Patients will connect on an interface to pratice speech therapy

Experimental
Speech therapy assessmentPROCEDURE

Patients will be followed by an speech therapist

ControlExperimental

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Patient with a speech disorder that may impair intelligibility and compromise the use of the interface;
  • Patient with an uncorrected hearing impairment,
  • Patients with a total intelligence quotient (IQ) \<70 (assessed in the context of care, in the year preceding the surgical procedure)
  • Patients who are pregnant, nursing, deprived of liberty, under guardianship or curatorship.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Service EFSN - Hôpital Pellegrin

Bordeaux, France

RECRUITING

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

Grenoble, France

RECRUITING

Département de Neurophysiologie Clinique - Hôpital Roger Salengro - CHU Lille

Lille, France

RECRUITING

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

Lyon, France

NOT YET RECRUITING

Service Epilptologie et Rythmologie Cérébrale

Marseille, France

RECRUITING

Service de Neurologie - Hôpital central -CHU Nancy

Nancy, France

NOT YET RECRUITING

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

Paris, France

NOT YET RECRUITING

Service de Neurochirurgie -GHU Sainte-Anne

Paris, France

NOT YET RECRUITING

Service de Neurologie - Fondation ophtalmologique de Rothschild - Fondation Rothschild

Paris, France

RECRUITING

Service de Neurologie - CHU de Rennes

Rennes, France

NOT YET RECRUITING

Service de Neurologie - Hôpitaux Universitaires, Hôpital de Hautepierre

Strasbourg, France

RECRUITING

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

Toulouse, France

NOT YET RECRUITING

MeSH Terms

Conditions

EpilepsyAnomiaEpilepsy, Temporal Lobe

Interventions

Speech Therapy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesLanguage DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsEpilepsies, PartialEpileptic Syndromes

Intervention Hierarchy (Ancestors)

Rehabilitation of Speech and Language DisordersRehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Francois CREMIEUX

    AP-HM

    STUDY DIRECTOR

Central Study Contacts

Veronique Sabadell

CONTACT

0491385298veronique.sabadell@ap-hm.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 25, 2022

First Posted

November 8, 2022

Study Start

March 30, 2023

Primary Completion (Estimated)

March 30, 2027

Study Completion (Estimated)

November 30, 2027

Last Updated

July 18, 2024

Record last verified: 2024-07

Locations

FR(12)