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EpilepsyREPREONCT05609084

Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy

A study testing Speech therapy and Speech therapy assessment in people with Epilepsy and Anomia, run by Assistance Publique Hopitaux De Marseille at 12 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Epilepsy, Anomia, Temporal Lobe Epilepsy
What is being tested?
Speech therapy and Speech therapy assessment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
214 participants
Where
12 sitesFrance
Study dates
30 Mar 2023to 30 Nov 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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.

Who cannot join

  • 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 locations and contacts

12 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Veronique Sabadell contact

0491385298 ext. 33

veronique.sabadell@ap-hm.fr

12 sites in 1 country

France12 sites, 12 recruiting

  • Service EFSN - Hôpital Pellegrin

    Bordeaux

    Véronique Michel

    Recruiting

  • Service de Neurologie de l'Epilepsie - CHU Grenoble-Alpes

    Grenoble

    LORELLA MINOTTI

    Recruiting

  • Département de Neurophysiologie Clinique - Hôpital Roger Salengro - CHU Lille

    Lille

    Philippe Derambure

    Recruiting

  • Hôpital Neurologique Pierre Wertheimer- Service de Neurologie Fonctionnelle et Epileptologie - Hospices Civils Lyon

    Lyon

    Alexandra Montavont

    Not yet recruiting

  • Service Epilptologie et Rythmologie Cérébrale

    Marseille

    Véronique Sabadell, veronique.sabadell@ap-hm.fr

    Agnes Trebuchon, agnes.trebuchon@ap-hm.fr

    Recruiting

  • Service de Neurologie - Hôpital central -CHU Nancy

    Nancy

    Louis Maillard

    Not yet recruiting

  • Département de Neurologie - Hôpital de la Pitié-Salpêtrière - APHP

    Paris

    Vincent Navarro

    Not yet recruiting

  • Service de Neurochirurgie -GHU Sainte-Anne

    Paris

    Elisabeth Landré

    Not yet recruiting

  • Service de Neurologie - Fondation ophtalmologique de Rothschild - Fondation Rothschild

    Paris

    Anca Nica

    Recruiting

  • Service de Neurologie - CHU de Rennes

    Rennes

    Mihai Dragos-Millia

    Not yet recruiting

  • Service de Neurologie - Hôpitaux Universitaires, Hôpital de Hautepierre

    Strasbourg

    Edouard Hirsch

    Recruiting

  • Explorations Neurophysiologiques, Pôle des Neurosciences - Hôpital Pierre Paul Riquet, Purpan

    Toulouse

    Marie Denuelle

    Not yet recruiting

Other trials in France

About this study

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.

Being tested
Speech therapy, Speech therapy assessment
Medical subject headings
Epilepsy, Anomia, Epilepsy, Temporal Lobe

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Speech therapyProcedure or surgery

    Patients will connect on an interface to pratice speech therapy

  • Speech therapy assessmentProcedure or surgery

    Patients will be followed by an speech therapist

Study groups in NCT05609084
Study groupRoleWhat they receive
ControlOtherPatients will have speech therapy assessment in addition to standard care.
Receives: Procedure: Speech therapy assessment
ExperimentalExperimentalPatients will have speech therapy assessment and intensive speech rehabilitation
Receives: Procedure: Speech therapy; Procedure: Speech therapy assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Effect of rehabilitation on immediate postoperative performances

    Number of images quoted

    Measured: Day 7 after surgery

Secondary outcomes (14)

  1. Impact of rehabilitation on long-term postoperative performance

    Number of images quoted

    Measured: 6 months after surgery

  2. Impact of rehabilitation on immediate on standardized language tests

    % of correct answers of language tests

    Measured: Day 7 after surgery

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

    % of correct answers of language tests

    Measured: 6 months after surgery

  4. Impact of preoperative rehabilitation on verbal memory

    Verbal memory task

    Measured: Day 7 after surgery

  5. Impact of preoperative rehabilitation on verbal memory

    Verbal memory task

    Measured: 6 months after surgery

  6. Lexical fluency

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

    Measured: Day 7 after surgery

  7. Lexical fluency

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

    Measured: 6 months after surgery

  8. Denomination of control lists

    Number of words quoted

    Measured: Day 7 after surgery

  9. Denomination of control lists

    Number of words quoted

    Measured: 6 months after surgery

  10. Self-reported perception of anomia

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

    Measured: Day 7 after surgery

  11. Self-reported perception of anomia

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

    Measured: 6 months after surgery

  12. Evaluation of Quality of life

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

    Measured: Day 7 after surgery

  13. Evaluation of Quality of life

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

    Measured: 6 months after surgery

  14. Impact of pre-operative rehabilitation on the number of post-operative rehabilitation sessions

    Number of speech therapy sessions performed postoperatively

    Measured: 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Nov 2022
  2. Study start30 Mar 2023
  3. Primary completion30 Mar 2027 (estimated)
  4. Study completion30 Nov 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
214 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05609084
Sponsor's protocol ID
2021-17
Other IDs
ID-RCB
Acronym
REPREO
Status last verified
Jul 2024
First submitted
25 Oct 2022
Last updated
18 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Speech therapy and Speech therapy assessment in people with Epilepsy and Anomia, run by Assistance Publique Hopitaux De Marseille at 12 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Veronique Sabadell (0491385298 ext. 33, veronique.sabadell@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Effect of rehabilitation on immediate postoperative performances (time frame: Day 7 after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05609084.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.

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