Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorAssistance Publique Hopitaux De Marseille
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
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,
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Speech therapy
Procedure/SurgeryPatients will connect on an interface to pratice speech therapy
Speech therapy assessment
Procedure/SurgeryPatients will be followed by an speech therapist
Treatment groups
214 Participants
are divided into 2 treatment groupsGroup A: ControlOther 1 intervention
Group B: ExperimentalExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Effect of rehabilitation on immediate postoperative performances
Number of images quoted
Time frame
Day 7 after surgerySecondary outcomes
1
Impact of rehabilitation on long-term postoperative performance
Number of images quoted
Time frame
6 months after surgery2
Impact of rehabilitation on immediate on standardized language tests
% of correct answers of language tests
Time frame
Day 7 after surgery3
Impact of rehabilitation on long-term postoperative performance on standardized language tests
% of correct answers of language tests
Time frame
6 months after surgery4
Impact of preoperative rehabilitation on verbal memory
Verbal memory task
Time frame
Day 7 after surgerySponsors and contacts
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Source ClinicalTrials.gov