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Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy: A Case Study

NCT05325047 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2023-07-20

No results posted yet for this study

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, a speech rehabilitation procedure specific to the needs of ELTPR patients was developed. Investigators rely on cognitive hypotheses explaining the disorders but also on models of rehabilitation-induced neural plasticity likely to improve cognitive reserve before surgery. Investigators hypothesize that preoperative cognitive language rehabilitation in ELTPR patients may decrease surgical risk and improve postoperative language prognosis.

The main objective is to demonstrate the efficacy of preoperative speech therapy on language performance and to evaluate possible protective effects on postoperative language prognosis.

Single case study following the Single Case Experimental Design (SCED) methodology involving the prior definition of the following elements: a repeated measure of the target behavior (naming abilities), the sequential introduction of an intervention (speech therapy), whose effect will be evaluated according to SCED specific analysis and statistics (visual analysis, Tau -U, randomized tests).

Investigators expect patients' naming performance to be stable before the introduction of speech therapy. It is expected that patients will progress in the trained words from the beginning of speech therapy. Finally, in the postoperative period, investigators predict that for the trained words, patients will show performances superior or equal to the pre-rehabilitation period. This result would support a protective effect of preoperative speech therapy.

Conditions

Interventions

PROCEDURE

Intensive speech rehabilitation

Combination an e-health device allowing the patient to self-rehabilitate with a face-to-face approach of accompaniment and support of the patient by the speech therapist.

Sponsors & Collaborators

  • Assistance Publique Hopitaux De Marseille

    lead OTHER

Principal Investigators

  • François CREMIEUX · APHM

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-20
Primary Completion
2023-02-03
Completion
2023-05-02

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05325047 on ClinicalTrials.gov