Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy

Epilepsy Clinical Trial

— REPREO  

Official title:

Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05609084
• Other study ID #: 2021-17
• Secondary ID: ID-RCB
• Status: Recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: November 30, 2025

Study information

• Verified date: November 2023
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Veronique Sabadell
• Phone: 0491385298
• Email: veronique.sabadell[@]ap-hm.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 214
• Est. completion date: November 30, 2025
• Est. primary completion date: March 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anomia
• Epilepsy
• Epilepsy, Temporal Lobe
• Temporal Lobe Epilepsy

Intervention

Procedure:
• Speech therapy
Patients will connect on an interface to pratice speech therapy
• Speech therapy assessment
Patients will be followed by an speech therapist

Locations

Country	Name	City	State
France	Service EFSN - Hôpital Pellegrin	Bordeaux
France	Service de Neurologie de l'Epilepsie - CHU Grenoble-Alpes	Grenoble
France	Département de Neurophysiologie Clinique - Hôpital Roger Salengro - CHU Lille	Lille
France	Hôpital Neurologique Pierre Wertheimer- Service de Neurologie Fonctionnelle et Epileptologie - Hospices Civils Lyon	Lyon
France	Service Epilptologie et Rythmologie Cérébrale	Marseille
France	Service de Neurologie - Hôpital central -CHU Nancy	Nancy
France	Département de Neurologie - Hôpital de la Pitié-Salpêtrière - APHP	Paris
France	Service de Neurochirurgie -GHU Sainte-Anne	Paris
France	Service de Neurologie - Fondation ophtalmologique de Rothschild - Fondation Rothschild	Paris
France	Service de Neurologie - CHU de Rennes	Rennes
France	Service de Neurologie - Hôpitaux Universitaires, Hôpital de Hautepierre	Strasbourg
France	Explorations Neurophysiologiques, Pôle des Neurosciences - Hôpital Pierre Paul Riquet, Purpan	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effect of rehabilitation on immediate postoperative performances	Number of images quoted	Day 7 after surgery
Secondary	Impact of rehabilitation on long-term postoperative performance	Number of images quoted	6 months after surgery
Secondary	Impact of rehabilitation on immediate on standardized language tests	% of correct answers of language tests	Day 7 after surgery
Secondary	Impact of rehabilitation on long-term postoperative performance on standardized language tests	% of correct answers of language tests	6 months after surgery
Secondary	Impact of preoperative rehabilitation on verbal memory	Verbal memory task	Day 7 after surgery
Secondary	Impact of preoperative rehabilitation on verbal memory	Verbal memory task	6 months after surgery
Secondary	Lexical fluency	Lexical evocation tests limited to 2 minutes according to a formal criterion or an imposed categorical criterion	Day 7 after surgery
Secondary	Lexical fluency	lexical evocation tests limited to 2 minutes according to a formal criterion or an imposed categorical criterion	6 months after surgery
Secondary	Denomination of control lists	Number of words quoted	Day 7 after surgery
Secondary	Denomination of control lists	Number of words quoted	6 months after surgery
Secondary	Self-reported perception of anomia	Use of an ad-hoc scale graduated from 0 (no complaint) to 10 (maximum complaint)	Day 7 after surgery
Secondary	Self-reported perception of anomia	Ad-hoc scale graduated from 0 (no complaint) to 10 (maximum complaint)	6 months after surgery
Secondary	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
Secondary	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
Secondary	Impact of pre-operative rehabilitation on the number of post-operative rehabilitation sessions	Number of speech therapy sessions performed postoperatively	6 months after surgery