Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy (REPREO)

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.

Study Overview

• Status: Recruiting
• Conditions: Epilepsy; Temporal Lobe Epilepsy; Anomia
• Intervention / Treatment: Procedure: Speech therapy assessment; Procedure: Speech therapy

• Study Type: Interventional
• Enrollment (Estimated): 214
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Veronique Sabadell; Phone Number: 33 0491385298; Email: veronique.sabadell@ap-hm.fr

Study Locations

• France
  • Bordeaux, France
    • Recruiting
    • Service EFSN - Hôpital Pellegrin
    • Contact: Véronique Michel
  • Grenoble, France
    • Recruiting
    • Service de Neurologie de l'Epilepsie - CHU Grenoble-Alpes
    • Contact: LORELLA MINOTTI
  • Lille, France
    • Recruiting
    • Département de Neurophysiologie Clinique - Hôpital Roger Salengro - CHU Lille
    • Contact: Philippe Derambure
  • Lyon, France
    • Not yet recruiting
    • Hôpital Neurologique Pierre Wertheimer- Service de Neurologie Fonctionnelle et Epileptologie - Hospices Civils Lyon
    • Contact: Alexandra Montavont
  • Marseille, France
    • Recruiting
    • Service Epilptologie et Rythmologie Cérébrale
    • Contact: Véronique Sabadell; Email: veronique.sabadell@ap-hm.fr
    • Contact: Agnes Trebuchon; Email: agnes.trebuchon@ap-hm.fr
  • Nancy, France
    • Not yet recruiting
    • Service de Neurologie - Hôpital central -CHU Nancy
    • Contact: Louis Maillard
  • Paris, France
    • Not yet recruiting
    • Département de Neurologie - Hôpital de la Pitié-Salpêtrière - APHP
    • Contact: Vincent Navarro
  • Paris, France
    • Not yet recruiting
    • Service de Neurochirurgie -GHU Sainte-Anne
    • Contact: Elisabeth Landré
  • Paris, France
    • Recruiting
    • Service de Neurologie - Fondation ophtalmologique de Rothschild - Fondation Rothschild
    • Contact: Anca Nica
  • Rennes, France
    • Not yet recruiting
    • Service de Neurologie - CHU de Rennes
    • Contact: Mihai Dragos-Millia
  • Strasbourg, France
    • Recruiting
    • Service de Neurologie - Hôpitaux Universitaires, Hôpital de Hautepierre
    • Contact: Edouard Hirsch
  • Toulouse, France
    • Not yet recruiting
    • Explorations Neurophysiologiques, Pôle des Neurosciences - Hôpital Pierre Paul Riquet, Purpan
    • Contact: Marie Denuelle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Patient 16 years of age and older,
2. Patient whose epileptogenic area involves the temporal structures of the hemisphere specialized for language,
3. Patient whose hemispheric specialization for language is known
4. Patient who accepts resective surgery such as anterior temporal lobectomy and whose planned surgery date is compatible with the study,
5. Patient with a known NTB score
6. 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)
7. Patient whose first language is French (1st language learned by the patient),
8. Patient declaring to be familiar with the use of a computer and having access to an internet connection from home
9. Patient affiliated or benefiting from a social security system.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control; Patients will have speech therapy assessment in addition to standard care.	Procedure: Speech therapy assessment; Patients will be followed by an speech therapist
Experimental: Experimental; Patients will have speech therapy assessment and intensive speech rehabilitation	Procedure: Speech therapy assessment; Patients will be followed by an speech therapist; Procedure: Speech therapy; Patients will connect on an interface to pratice speech therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of rehabilitation on immediate postoperative performances	Number of images quoted	Day 7 after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of rehabilitation on long-term postoperative performance	Number of images quoted	6 months after surgery
Impact of rehabilitation on immediate on standardized language tests	% of correct answers of language tests	Day 7 after surgery
Impact of rehabilitation on long-term postoperative performance on standardized language tests	% of correct answers of language tests	6 months after surgery
Impact of preoperative rehabilitation on verbal memory	Verbal memory task	Day 7 after surgery
Impact of preoperative rehabilitation on verbal memory	Verbal memory task	6 months after surgery
Lexical fluency	Lexical evocation tests limited to 2 minutes according to a formal criterion or an imposed categorical criterion	Day 7 after surgery
Lexical fluency	lexical evocation tests limited to 2 minutes according to a formal criterion or an imposed categorical criterion	6 months after surgery
Denomination of control lists	Number of words quoted	Day 7 after surgery
Denomination of control lists	Number of words quoted	6 months after surgery
Self-reported perception of anomia	Use of an ad-hoc scale graduated from 0 (no complaint) to 10 (maximum complaint)	Day 7 after surgery
Self-reported perception of anomia	Ad-hoc scale graduated from 0 (no complaint) to 10 (maximum complaint)	6 months after surgery
Evaluation of Quality of life	Quality Of Life in Epilepsy Inventory (QOLIE-31) (0 meaning better outcome, highest score meaning worse outcome)	Day 7 after surgery
Evaluation of Quality of life	Quality Of Life in Epilepsy Inventory (QOLIE-31) (0 meaning better outcome, highest score meaning worse outcome)	6 months after surgery
Impact of pre-operative rehabilitation on the number of post-operative rehabilitation sessions	Number of speech therapy sessions performed postoperatively	6 months after surgery

Collaborators and Investigators

• Sponsor: Assistance Publique Hopitaux De Marseille
• Investigators: Study Director: François Cremieux, AP-HM

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Estimated): March 30, 2025
• Study Completion (Estimated): November 30, 2025

Study Registration Dates

• First Submitted: October 25, 2022
• First Submitted That Met QC Criteria: November 6, 2022
• First Posted (Actual): November 8, 2022

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epileptic Syndromes; Epilepsies, Partial; Epilepsy; Epilepsy, Temporal Lobe
• Other Study ID Numbers: 2021-17; ID-RCB (Other Identifier: 2023-A01937-38)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No