search
Back to results

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

Primary Purpose

Epilepsy, Anomia, Temporal Lobe Epilepsy

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Speech therapy
Speech therapy assessment
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Epilepsy

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 by fMRI (performed as part of care), Patient who accepts resective surgery such as anterior temporal lobectomy and whose planned surgery date is compatible with 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. Exclusion Criteria: 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.

Sites / Locations

  • Service EFSN - Hôpital PellegrinRecruiting
  • Service de Neurologie de l'Epilepsie - CHU Grenoble-AlpesRecruiting
  • Département de Neurophysiologie Clinique - Hôpital Roger Salengro - CHU Lille
  • Hôpital Neurologique Pierre Wertheimer- Service de Neurologie Fonctionnelle et Epileptologie - Hospices Civils Lyon
  • Service Epilptologie et Rythmologie CérébraleRecruiting
  • Service de Neurologie - Hôpital central -CHU Nancy
  • Département de Neurologie - Hôpital de la Pitié-Salpêtrière - APHP
  • Service de Neurochirurgie -GHU Sainte-Anne
  • Service de Neurologie - Fondation ophtalmologique de Rothschild - Fondation Rothschild
  • Service de Neurologie - CHU de Rennes
  • Service de Neurologie - Hôpitaux Universitaires, Hôpital de Hautepierre
  • Explorations Neurophysiologiques, Pôle des Neurosciences - Hôpital Pierre Paul Riquet, Purpan

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Control

Experimental

Arm Description

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

Patients will have speech therapy assessment and intensive speech rehabilitation

Outcomes

Primary Outcome Measures

Effect of rehabilitation on immediate postoperative performances
Number of images quoted

Secondary Outcome Measures

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

Full Information

First Posted
October 25, 2022
Last Updated
September 8, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
search

1. Study Identification

Unique Protocol Identification Number
NCT05609084
Brief Title
Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy
Acronym
REPREO
Official Title
Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 30, 2023 (Actual)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
November 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Anomia, Temporal Lobe Epilepsy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
Patients will have speech therapy assessment in addition to standard care.
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Patients will have speech therapy assessment and intensive speech rehabilitation
Intervention Type
Procedure
Intervention Name(s)
Speech therapy
Intervention Description
Patients will connect on an interface to pratice speech therapy
Intervention Type
Procedure
Intervention Name(s)
Speech therapy assessment
Intervention Description
Patients will be followed by an speech therapist
Primary Outcome Measure Information:
Title
Effect of rehabilitation on immediate postoperative performances
Description
Number of images quoted
Time Frame
Day 7 after surgery
Secondary Outcome Measure Information:
Title
Impact of rehabilitation on long-term postoperative performance
Description
Number of images quoted
Time Frame
6 months after surgery
Title
Impact of rehabilitation on immediate on standardized language tests
Description
% of correct answers of language tests
Time Frame
Day 7 after surgery
Title
Impact of rehabilitation on long-term postoperative performance on standardized language tests
Description
% of correct answers of language tests
Time Frame
6 months after surgery
Title
Impact of preoperative rehabilitation on verbal memory
Description
Verbal memory task
Time Frame
Day 7 after surgery
Title
Impact of preoperative rehabilitation on verbal memory
Description
Verbal memory task
Time Frame
6 months after surgery
Title
Lexical fluency
Description
Lexical evocation tests limited to 2 minutes according to a formal criterion or an imposed categorical criterion
Time Frame
Day 7 after surgery
Title
Lexical fluency
Description
lexical evocation tests limited to 2 minutes according to a formal criterion or an imposed categorical criterion
Time Frame
6 months after surgery
Title
Denomination of control lists
Description
Number of words quoted
Time Frame
Day 7 after surgery
Title
Denomination of control lists
Description
Number of words quoted
Time Frame
6 months after surgery
Title
Self-reported perception of anomia
Description
Use of an ad-hoc scale graduated from 0 (no complaint) to 10 (maximum complaint)
Time Frame
Day 7 after surgery
Title
Self-reported perception of anomia
Description
Ad-hoc scale graduated from 0 (no complaint) to 10 (maximum complaint)
Time Frame
6 months after surgery
Title
Evaluation of Quality of life
Description
Quality Of Life in Epilepsy Inventory (QOLIE-31) (0 meaning better outcome, highest score meaning worse outcome)
Time Frame
Day 7 after surgery
Title
Evaluation of Quality of life
Description
Quality Of Life in Epilepsy Inventory (QOLIE-31) (0 meaning better outcome, highest score meaning worse outcome)
Time Frame
6 months after surgery
Title
Impact of pre-operative rehabilitation on the number of post-operative rehabilitation sessions
Description
Number of speech therapy sessions performed postoperatively
Time Frame
6 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 by fMRI (performed as part of care), Patient who accepts resective surgery such as anterior temporal lobectomy and whose planned surgery date is compatible with 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Veronique Sabadell
Phone
0491385298
Ext
33
Email
veronique.sabadell@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois CREMIEUX
Organizational Affiliation
AP-HM
Official's Role
Study Director
Facility Information:
Facility Name
Service EFSN - Hôpital Pellegrin
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique Michel
Facility Name
Service de Neurologie de l'Epilepsie - CHU Grenoble-Alpes
City
Grenoble
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LORELLA MINOTTI
Facility Name
Département de Neurophysiologie Clinique - Hôpital Roger Salengro - CHU Lille
City
Lille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Philippe Derambure
Facility Name
Hôpital Neurologique Pierre Wertheimer- Service de Neurologie Fonctionnelle et Epileptologie - Hospices Civils Lyon
City
Lyon
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Montavont
Facility Name
Service Epilptologie et Rythmologie Cérébrale
City
Marseille
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique Sabadell
Email
veronique.sabadell@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Agnes Trebuchon
Email
agnes.trebuchon@ap-hm.fr
Facility Name
Service de Neurologie - Hôpital central -CHU Nancy
City
Nancy
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Louis Maillard
Facility Name
Département de Neurologie - Hôpital de la Pitié-Salpêtrière - APHP
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincent Navarro
Facility Name
Service de Neurochirurgie -GHU Sainte-Anne
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabeth Landré
Facility Name
Service de Neurologie - Fondation ophtalmologique de Rothschild - Fondation Rothschild
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anca Nica
Facility Name
Service de Neurologie - CHU de Rennes
City
Rennes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mihai Dragos-Millia
Facility Name
Service de Neurologie - Hôpitaux Universitaires, Hôpital de Hautepierre
City
Strasbourg
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edouard Hirsch
Facility Name
Explorations Neurophysiologiques, Pôle des Neurosciences - Hôpital Pierre Paul Riquet, Purpan
City
Toulouse
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luc Valton

12. IPD Sharing Statement

Learn more about this trial

Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy

We'll reach out to this number within 24 hrs