Epilepsy Clinical Trial
— REPREOOfficial title:
Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique Hopitaux De Marseille |
France,
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT04595513 -
Stopping TSC Onset and Progression 2: Epilepsy Prevention in TSC Infants
|
Phase 1/Phase 2 | |
Completed |
NCT02909387 -
Adapting Project UPLIFT for Blacks in Georgia
|
N/A | |
Completed |
NCT05552924 -
Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients
|
N/A | |
Terminated |
NCT01668654 -
Long-term, Open-label Safety Extension Study of Retigabine/Ezogabine in Pediatric Subjects (>= 12 Years Old) With POS or LGS
|
Phase 3 | |
Not yet recruiting |
NCT05068323 -
Impact of Interictal Epileptiform Activity on Some Cognitive Domains in Newly Diagnosed Epileptic Patients
|
N/A | |
Completed |
NCT03994718 -
Creative Arts II Study
|
N/A | |
Recruiting |
NCT04076449 -
Quantitative Susceptibility Biomarker and Brain Structural Property for Cerebral Cavernous Malformation Related Epilepsy
|
||
Completed |
NCT00782249 -
Trial Comparing Different Stimulation Paradigms in Patients Treated With Vagus Nerve Stimulation for Refractory Epilepsy
|
N/A | |
Completed |
NCT03683381 -
App-based Intervention for Treating Insomnia Among Patients With Epilepsy
|
N/A | |
Recruiting |
NCT05101161 -
Neurofeedback Using Implanted Deep Brain Stimulation Electrodes
|
N/A | |
Active, not recruiting |
NCT06034353 -
Impact of Pharmacist-led Cognitive Behavioral Intervention on Adherence and Quality of Life of Epileptic Patients
|
N/A | |
Recruiting |
NCT05769933 -
Bridging Gaps in the Neuroimaging Puzzle: New Ways to Image Brain Anatomy and Function in Health and Disease Using Electroencephalography and 7 Tesla Magnetic Resonance Imaging
|
||
Not yet recruiting |
NCT06408428 -
Glioma Intraoperative MicroElectroCorticoGraphy
|
N/A | |
Not yet recruiting |
NCT05559060 -
Comorbidities of Epilepsy(Cognitive and Psychiatric Dysfunction)
|
||
Completed |
NCT02977208 -
Impact of Polymorphisms of OCT2 and OCTN1 on the Kinetic Disposition of Gabapentin in Patients Undergoing Chronic Use
|
Phase 4 | |
Completed |
NCT02646631 -
Behavioral and Educational Tools to Improve Epilepsy Care
|
N/A | |
Completed |
NCT02952456 -
Phenomenological Approach of Epilepsy in Patients With Epilepsy
|
||
Recruiting |
NCT02539134 -
TAK-935 Multiple Rising Dose Study in Healthy Participants
|
Phase 1 | |
Completed |
NCT02491073 -
Study to Evaluate Serum Free Thyroxine (FT4) and Free Triiodothyronine (FT3) Measurements for Subjects Treated With Eslicarbazeine Acetate (ESL)
|
N/A | |
Terminated |
NCT02757547 -
Transcranial Magnetic Stimulation for Epilepsy
|
N/A |