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Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy

Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05609084
Acronym
REPREO
Enrollment
214
Registered
2022-11-08
Start date
2023-03-30
Completion date
2027-11-30
Last updated
2024-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anomia, Epilepsy, Temporal Lobe Epilepsy

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.

Interventions

PROCEDURESpeech therapy

Patients will connect on an interface to pratice speech therapy

PROCEDURESpeech therapy assessment

Patients will be followed by an speech therapist

Sponsors

Assistance Publique Hopitaux De Marseille
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

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 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, 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.

Design outcomes

Primary

MeasureTime frameDescription
Effect of rehabilitation on immediate postoperative performancesDay 7 after surgeryNumber of images quoted

Secondary

MeasureTime frameDescription
Impact of rehabilitation on immediate on standardized language testsDay 7 after surgery% of correct answers of language tests
Impact of rehabilitation on long-term postoperative performance on standardized language tests6 months after surgery% of correct answers of language tests
Impact of preoperative rehabilitation on verbal memoryDay 7 after surgeryVerbal memory task
Lexical fluencyDay 7 after surgeryLexical evocation tests limited to 2 minutes according to a formal criterion or an imposed categorical criterion
Impact of rehabilitation on long-term postoperative performance6 months after surgeryNumber of images quoted
Self-reported perception of anomiaDay 7 after surgeryUse of an ad-hoc scale graduated from 0 (no complaint) to 10 (maximum complaint)
Evaluation of Quality of lifeDay 7 after surgeryQuality 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 sessions6 months after surgeryNumber of speech therapy sessions performed postoperatively
Denomination of control listsDay 7 after surgeryNumber of words quoted

Countries

France

Contacts

Primary ContactVeronique Sabadell
veronique.sabadell@ap-hm.fr0491385298

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026