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NCT Number: NCT05609084

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.

Recruiting

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Service EFSN - Hôpital Pellegrin, Bordeaux, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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,
  • Patient with a known NTB score
  • 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)
  • Patient whose first language is French (1st language learned by the patient),
  • Patient declaring to be familiar with the use of a computer and having access to an internet connection from home
  • Patient affiliated or benefiting from a social security system.

Exclusion criteria

  • 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.

Treatment and study plan

Speech therapy

Procedure

Patients will connect on an interface to pratice speech therapy

Speech therapy assessment

Procedure

Patients will be followed by an speech therapist

Primary outcomes

  1. Effect of rehabilitation on immediate postoperative performances

    Time frame: Day 7 after surgery

    Number of images quoted

Secondary outcomes

  1. Impact of rehabilitation on long-term postoperative performance

    Time frame: 6 months after surgery

    Number of images quoted

  2. Impact of rehabilitation on immediate on standardized language tests

    Time frame: Day 7 after surgery

    % of correct answers of language tests

  3. Impact of rehabilitation on long-term postoperative performance on standardized language tests

    Time frame: 6 months after surgery

    % of correct answers of language tests

  4. Impact of preoperative rehabilitation on verbal memory

    Time frame: Day 7 after surgery

    Verbal memory task

  5. Impact of preoperative rehabilitation on verbal memory

    Time frame: 6 months after surgery

    Verbal memory task

  6. Lexical fluency

    Time frame: Day 7 after surgery

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

  7. Lexical fluency

    Time frame: 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

    Time frame: Day 7 after surgery

    Number of words quoted

  9. Denomination of control lists

    Time frame: 6 months after surgery

    Number of words quoted

  10. Self-reported perception of anomia

    Time frame: 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

    Time frame: 6 months after surgery

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

  12. Evaluation of Quality of life

    Time frame: 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

    Time frame: 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

    Time frame: 6 months after surgery

    Number of speech therapy sessions performed postoperatively

Study contacts

Contact information is provided by the study sponsor or research team.

Veronique Sabadell

CONTACT

[email protected]

0491385298 ext. 33

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Acronym: REPREO

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Nov 8, 2022
Registry last updated
Jul 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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