REPREO: Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy

Sponsor
Assistance Publique Hopitaux De Marseille (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05609084
Collaborator
(none)
188
2
32

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Speech therapy
  • Procedure: Speech therapy assessment
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
188 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Aug 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Other: Control

Patients will have speech therapy assessment in addition to standard care.

Procedure: Speech therapy assessment
Patients will be followed by an speech therapist

Experimental: Experimental

Patients will have speech therapy assessment and intensive speech rehabilitation

Procedure: Speech therapy
Patients will connect on an interface to pratice speech therapy

Procedure: Speech therapy assessment
Patients will be followed by an speech therapist

Outcome Measures

Primary Outcome Measures

  1. Effect of rehabilitation on immediate postoperative performances [Day 7 after surgery]

    Number of images quoted

Secondary Outcome Measures

  1. Impact of rehabilitation on long-term postoperative performance [6 months after surgery]

    Number of images quoted

  2. Impact of rehabilitation on immediate on standardized language tests [Day 7 after surgery]

    % of correct answers of language tests

  3. Impact of rehabilitation on long-term postoperative performance on standardized language tests [6 months after surgery]

    % of correct answers of language tests

  4. Impact of preoperative rehabilitation on verbal memory [Day 7 after surgery]

    Verbal memory task

  5. Impact of preoperative rehabilitation on verbal memory [6 months after surgery]

    Verbal memory task

  6. Lexical fluency [Day 7 after surgery]

    Lexical evocation tests limited to 2 minutes according to a formal criterion or an imposed categorical criterion

  7. Lexical fluency [6 months after surgery]

    lexical evocation tests limited to 2 minutes according to a formal criterion or an imposed categorical criterion

  8. Denomination of control lists [Day 7 after surgery]

    Number of words quoted

  9. Denomination of control lists [6 months after surgery]

    Number of words quoted

  10. Self-reported perception of anomia [Day 7 after surgery]

    Use of an ad-hoc scale graduated from 0 (no complaint) to 10 (maximum complaint)

  11. Self-reported perception of anomia [6 months after surgery]

    Ad-hoc scale graduated from 0 (no complaint) to 10 (maximum complaint)

  12. Evaluation of Quality of life [Day 7 after surgery]

    Quality Of Life in Epilepsy Inventory (QOLIE-31) (0 meaning better outcome, highest score meaning worse outcome)

  13. Evaluation of Quality of life [6 months after surgery]

    Quality Of Life in Epilepsy Inventory (QOLIE-31) (0 meaning better outcome, highest score meaning worse outcome)

  14. Impact of pre-operative rehabilitation on the number of post-operative rehabilitation sessions [6 months after surgery]

    Number of speech therapy sessions performed postoperatively

Eligibility Criteria

Criteria

Ages Eligible for Study:
16 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. Patient 16 years of age or older,

  2. 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)

  3. Patient whose epileptogenic zone involves the temporal structures of the hemisphere specialized for language,

  4. Patient whose hemispheric specialization for language is known by fMRI (performed as part of care),

  5. Patient willing to undergo resective surgery such as anterior temporal lobectomy and whose planned surgery date is compatible with the study,

  6. Patient whose mother tongue is French (1st language learned by the patient),

  7. Patient declaring to be familiar with the use of a computer and having access to an internet connection from home

  8. Patient with a known NTB score

  9. Patient affiliated or benefiting from a social security plan.

Exclusion Criteria:
  1. Pregnant, breastfeeding, deprived of liberty, under guardianship or curatorship;

  2. Patients with speech disorders that may impair intelligibility and compromise the use of the interface;

  3. Patient with an uncorrected hearing impairment,

  4. Patient with a total intelligence quotient (IQ) <70 (evaluated in the context of care, in the year preceding the surgical procedure)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assistance Publique Hopitaux De Marseille

Investigators

  • Study Director: Francois CREMIEUX, AP-HM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT05609084
Other Study ID Numbers:
  • 2021-17
  • ID-RCB
First Posted:
Nov 8, 2022
Last Update Posted:
Nov 8, 2022
Last Verified:
Nov 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Nov 8, 2022