EpilepsyREPREO SCEDNCT05325047
Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy: A Case Study
A study testing Intensive speech rehabilitation in people with Epilepsy, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 18 years and older
- Conditions the study is for
- Epilepsy
- What is being tested?
- Intensive speech rehabilitation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteFrance
- Study dates
- 20 Sep 2022to 2 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy: A Case 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, 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.
Read more
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
- Epilepsy
- Being tested
- Intensive speech rehabilitation
- Keywords
- speech rehabilitation, epilepsy, frontal lobe, anomia
- Medical subject headings
- Epilepsy, Anomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive speech rehabilitationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Speech rehabilitation | Experimental | Not described Receives: Procedure: Intensive speech rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effectiveness of preoperative speech rehabilitation
Measurement of naming performance (score and response time) for trained items.
Measured: Day 7
Effectiveness of preoperative speech rehabilitation
Measurement of naming performance (score and response time) for trained items.
Measured: Day 14
Effectiveness of preoperative speech rehabilitation
Measurement of naming performance (score and response time) for trained items.
Measured: Day 21
Effectiveness of preoperative speech rehabilitation
Measurement of naming performance (score and response time) for trained items.
Measured: Day 28
Effectiveness of preoperative speech rehabilitation
Measurement of naming performance (score and response time) for trained items.
Measured: Day 35
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start20 Sep 2022
- Primary completion3 Feb 2023
- Study completion2 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpilepsyStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François CREMIEUX, Study director, APHM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325047
- Sponsor's protocol ID
- 2021-02
- Other IDs
- ID-RCB
- Acronym
- REPREO SCED
- Status last verified
- Jul 2023
- First submitted
- 5 Apr 2022
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Preoperative Speech Rehabilitation in Drug-Resistant Temporal Epilepsy: A Case Study
- ClinicalTrials.gov ID
- NCT05325047
- Acronym / sponsor ID
- REPREO SCED / 2021-02
- Conditions
- Epilepsy
- Keywords
- speech rehabilitation, epilepsy, frontal lobe, anomia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 3 Feb 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Speech rehabilitation | Experimental | Procedure: Intensive speech rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensive speech rehabilitationCombination 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. | Procedure or surgery | Speech rehabilitation |
Primary outcome
Effectiveness of preoperative speech rehabilitation
Time frame: Day 7
Measurement of naming performance (score and response time) for trained items.
Effectiveness of preoperative speech rehabilitation
Time frame: Day 14
Measurement of naming performance (score and response time) for trained items.
Effectiveness of preoperative speech rehabilitation
Time frame: Day 21
Measurement of naming performance (score and response time) for trained items.
Effectiveness of preoperative speech rehabilitation
Time frame: Day 28
Measurement of naming performance (score and response time) for trained items.
Effectiveness of preoperative speech rehabilitation
Time frame: Day 35
Measurement of naming performance (score and response time) for trained items.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François CREMIEUX study director
APHM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive speech rehabilitation in people with Epilepsy, run by Assistance Publique Hopitaux De Marseille at 1 site 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 6 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: finished, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effectiveness of preoperative speech rehabilitation (time frame: Day 7). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jul 2023.