Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy: A Case Study (REPREO SCED)
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Intensive speech rehabilitation
Sponsored by
About this trial
This is an interventional prevention trial for Epilepsy focused on measuring speech rehabilitation, epilepsy, frontal lobe, anomia
Eligibility Criteria
Inclusion Criteria:
- Patient of legal age,
- Patient with signed informed consent,
- Patient whose epileptogenic area involves the temporal structures of the hemisphere specialized for language,
- Patient with known hemispheric specialization for language (fMRI),
- Patient who is a surgical candidate and accepts resective surgery,
- Patient for whom a surgery date compatible with the study design has been set;
- Patient of French nationality and mother tongue (1st language learned by the patient),
- Patient affiliated to or benefiting from a social security system,
- Patient declaring to be familiar with the use of a computer and having access to an Internet connection from home.
Exclusion Criteria:
- Pregnant or breastfeeding patients,
- Patients deprived of liberty,
- Patients under guardianship or curatorship
- Patients with speech disorders that may impair intelligibility and compromise the use of the interface,
- Patients with uncorrected hearing impairment,
- Patients with low overall intellectual functioning: total intelligence quotient (IQ) <70 (data from the preoperative neuropsychological assessment performed in the year preceding the surgery)
Sites / Locations
- CHU Bordeaux
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Speech rehabilitation
Arm Description
Outcomes
Primary Outcome Measures
Effectiveness of preoperative speech rehabilitation
Measurement of naming performance (score and response time) for trained items.
Effectiveness of preoperative speech rehabilitation
Measurement of naming performance (score and response time) for trained items.
Effectiveness of preoperative speech rehabilitation
Measurement of naming performance (score and response time) for trained items.
Effectiveness of preoperative speech rehabilitation
Measurement of naming performance (score and response time) for trained items.
Effectiveness of preoperative speech rehabilitation
Measurement of naming performance (score and response time) for trained items.
Secondary Outcome Measures
Full Information
NCT ID
NCT05325047
First Posted
April 5, 2022
Last Updated
July 19, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT05325047
Brief Title
Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy: A Case Study
Acronym
REPREO SCED
Official Title
Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy: A Case Study
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
February 3, 2023 (Actual)
Study Completion Date
May 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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, 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
speech rehabilitation, epilepsy, frontal lobe, anomia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Speech rehabilitation
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Intensive speech rehabilitation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Effectiveness of preoperative speech rehabilitation
Description
Measurement of naming performance (score and response time) for trained items.
Time Frame
Day 7
Title
Effectiveness of preoperative speech rehabilitation
Description
Measurement of naming performance (score and response time) for trained items.
Time Frame
Day 14
Title
Effectiveness of preoperative speech rehabilitation
Description
Measurement of naming performance (score and response time) for trained items.
Time Frame
Day 21
Title
Effectiveness of preoperative speech rehabilitation
Description
Measurement of naming performance (score and response time) for trained items.
Time Frame
Day 28
Title
Effectiveness of preoperative speech rehabilitation
Description
Measurement of naming performance (score and response time) for trained items.
Time Frame
Day 35
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient of legal age,
Patient with signed informed consent,
Patient whose epileptogenic area involves the temporal structures of the hemisphere specialized for language,
Patient with known hemispheric specialization for language (fMRI),
Patient who is a surgical candidate and accepts resective surgery,
Patient for whom a surgery date compatible with the study design has been set;
Patient of French nationality and mother tongue (1st language learned by the patient),
Patient affiliated to or benefiting from a social security system,
Patient declaring to be familiar with the use of a computer and having access to an Internet connection from home.
Exclusion Criteria:
Pregnant or breastfeeding patients,
Patients deprived of liberty,
Patients under guardianship or curatorship
Patients with speech disorders that may impair intelligibility and compromise the use of the interface,
Patients with uncorrected hearing impairment,
Patients with low overall intellectual functioning: total intelligence quotient (IQ) <70 (data from the preoperative neuropsychological assessment performed in the year preceding the surgery)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
François CREMIEUX
Organizational Affiliation
APHM
Official's Role
Study Director
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy: A Case Study
We'll reach out to this number within 24 hrs