Minor StrokeCOGaDOMNCT06306144
Early-phase Telecare Programs for Minor Stroke
A study testing Psychoeducation and Computerised Cognitive Stimulation in people with Minor Stroke, run by Hospices Civils de Lyon at 3 sites in France.
Trial summary
Minor strokes (few acute neurological symptoms ; NIHSS score <5), represent almost 65% of cerebrovascular ischemic events. The increasing incidence of stroke in people under 65, together with advances in diagnostic and revascularization techniques, mean that post-stroke life expectancy is now in the order of decades. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Minor Stroke
- What is being tested?
- Psychoeducation and Computerised Cognitive Stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 3 sitesFrance
- Study dates
- 1 May 2025to 1 Jun 2028
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Man or woman, aged between 18 and 65 years old
- Hospitalization for a first stroke
- Minor stroke: NIHSS score < 5 on discharge from neurovascular unit
- Post-stroke delay < 8 weeks
- Living at home (not institutionalized)
- Affiliated with social security or benefiting from such a scheme
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- French language
- Presence of a cognitive complaint (FACT-Cog "perceived cognitive impairments" subscale score < 55) and absence of major cognitive impairment
- Signature of informed consent
Who cannot join
- History of stroke
- Uncorrected hearing or visual impairment
- Neurological pathology other than stroke or disabling psychiatric disorder
- Unstabilized epilepsy
- Undergoing cognitive rehabilitation in another context or having integrated a post-stroke therapeutic education program
- Living in a white zone that does not allow for remote rehabilitation
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- Unable to connect to the Internet
- Pregnant, parturient or breast-feeding women* (interview data)
- Persons deprived of their liberty by judicial or administrative decision
- Persons admitted to a health or social institution for purposes other than research
- Adults under legal protection (guardianship, curatorship)
- Taking part in other interventional research involving a period of exclusion still in progress at pre-inclusion
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France3 sites
CHU de Bordeaux
Bordeaux, 33000
GLIZE Bertrand, 05 56 79 56 79, bertrand.glize@chu-bordeaux.fr
CHU Lille
Lille, 59037
ALLART Etienne, Dr, 03 20 44 48 71, etienne.allart@chu-lille.fr
Hôpital Henry Gabrielle
Saint-Genis-Laval, 69230
PUGNIET Virginie, 04.78.86.50.64, virginie.pugniet@chu-lyon.fr
About this study
Official title: Mild Cognitive Impairment After Minor Stroke: Evaluation of Early-phase Telecare Programs (Psychoeducation and Computerized Cognitive Stimulation)
Minor strokes (few acute neurological symptoms ; NIHSS score <5), represent almost 65% of cerebrovascular ischemic events. The increasing incidence of stroke in people under 65, together with advances in diagnostic and revascularization techniques, mean that post-stroke life expectancy is now in the order of decades. Most patients with minor stroke are rapidly discharged from hospital, with follow-up focused on secondary prevention and they are offered little or no rehabilitation.
However, up to 70% of patients with minor stroke experience difficulties resuming their social or professional activities, which can lead to social and economic disruption (delayed/compromised return to work) and an increased risk of depression. While some care recommendations exist for this population, in France there is no consensus nor identified care pathway for follow-up assessment or management of these patients. Furthermore, existing services are unevenly distributed across the country, and research into the effectiveness of rehabilitation is still scarce, leading to uncertainty as to which interventions should be prioritized to decrease difficulties related to cognitive impairment.
Since there are currently no rehabilitation proposals in France for patients with mild cognitive impairment after mild stroke, in this trial the investigaror will investigate the effectiveness of two six-week telerehabilitation programs each consisting of a weekly session supervised by a therapist and a self-rehabilitation session. The aim of this multicenter randomized controlled trial is the evaluate the relevance and feasibility of early identification of patients eligible for a cognition-focused management proposal and the efficacy of two telecare programs, (a) psychoeducation and (b) computerized cognitive rehabilitation.
- Conditions
- Minor Stroke
- Being tested
- Psychoeducation, Computerised Cognitive Stimulation, Usual Care
- Keywords
- cognitive complaint, computerized stimulation, psychoeducation, tele-rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PsychoeducationBehavioural
Arm 1 : Psychoeducation aims to inform patients about post-stroke cognitive impairment, teach them coping strategies to compensate for these difficulties, provide information on symptom recognition and management, and offer emotional and psychological support to help them meet the challenges associated with these potential cognitive impairments.
Computerised Cognitive StimulationBehavioural
Arm 2 :Patients will participate in a 6-week cognitive stimulation telerehabilitation intervention, that will consist of two 45-minute sessions per week. Each week they will participate in a 45-minute on-line session with a rehabilitation clinician and later in the week will complete 45 minutes of on-line exercises set by the rehabilitation clinician
Usual CareBehavioural
Arm 3 : No specific care.
| Study group | Role | What they receive |
|---|---|---|
| Patients receiving the Psychoeducation Intervention | Experimental | Patients will participate in a 6-week psychoeducation telerehabilitation intervention, that will consist of two 45-minute sessions per week. Each week they will participate in a 45-minute on-line session with a rehabilitation clinician and later in the week will complete 45 minutes of exercises set by the rehabilitation clinician Receives: Behavioral: Psychoeducation |
| Patients receiving the Computerised Cognitive Stimulation Intervention | Experimental | Patients will participate in a 6-week cognitive stimulation telerehabilitation intervention, that will consist of two 45-minute sessions per week. Each week they will participate in a 45-minute on-line session with a rehabilitation clinician and later in the week will complete 45 minutes of on-line exercises set by the rehabilitation clinician. Receives: Behavioral: Computerised Cognitive Stimulation |
| Patients receiving the Usual Care | Experimental | Patients randomized to this group will complete the questionnaires and the cognitive tests but will receive no intervention Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study is to demonstrate the benefits of early management following a minor stroke on participation at 6 months post-stroke.
Difference in the Participation score (from the Participation subscale of the stroke impact scale) between the pre-intervention evaluation and the evaluation 6 months post-stroke, between the intervention and non-intervention groups
Measured: At the end of the study : 36 months
Secondary outcomes (8)
to evaluate the effects on quality of life of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
the effects of the proposed programs will be evaluated with quality of life measured using the WHOQOL-BREF Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Measured: At the end of the study : 36 months
to evaluate the effects on cognitive complaint of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
the effects of the proposed programs will be evaluated with cognitive complaint measured using the FACT-Cog;
Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Measured: At the end of the study : 36 months
to evaluate the effects on cognitive function of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
the effects of the proposed programs will be evaluated with cognitive function (notably attentional, executive and memory functions) measured using a custom-designed battery of neuropsychological tests;
Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Measured: At the end of the study : 36 months
to evaluate the effects on mood and anxiety of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
the effects of the proposed programs on mood and anxiety will be measured by the HADS
Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Measured: At the end of the study : 36 months
to evaluate the effects on fatigue of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
the effects of the proposed programs on fatigue will be measured by the FACIT-Fatigue
Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Measured: At the end of the study : 36 months
to evaluate the effects on participation of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
the effects of the proposed programs on participation will be measured by the score on the Participation subscale of the Stroke Impact Scale
Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Measured: At the end of the study : 36 months
to evaluate the effects on health status of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
the effects of the proposed programs on health status will be measured by EQ-5D-5L;
Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Measured: At the end of the study : 36 months
to evaluate the effects on health status of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
the effects of the proposed programs on the medico-economic impact of these interventions.
Difference in each outcome measure score between the pre-intervention evaluation and the evaluations post-intervention and at 9 months post-stroke, between the intervention and non-intervention groups.
Measured: At the end of the study : 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start1 May 2025 (estimated)
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Minor StrokeStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06306144
- Sponsor's protocol ID
- 69HCL23_0691
- Acronym
- COGaDOM
- Status last verified
- Apr 2025
- First submitted
- 28 Feb 2024
- Last updated
- 18 Apr 2025
- 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 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild Cognitive Impairment After Minor Stroke: Evaluation of Early-phase Telecare Programs (Psychoeducation and Computerized Cognitive Stimulation)
- ClinicalTrials.gov ID
- NCT06306144
- Acronym / sponsor ID
- COGaDOM / 69HCL23_0691
- Conditions
- Minor Stroke
- Keywords
- cognitive complaint, computerized stimulation, psychoeducation, tele-rehabilitation
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 May 2025 (estimated)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 12 Mar 2024 (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.
Minor strokes (few acute neurological symptoms ; NIHSS score <5), represent almost 65% of cerebrovascular ischemic events. The increasing incidence of stroke in people under 65, together with advances in diagnostic and revascularization techniques, mean that post-stroke life expectancy is now in the order of decades. Most patients with minor stroke are rapidly discharged from hospital, with follow-up focused on secondary prevention and they are offered little or no rehabilitation.
However, up to 70% of patients with minor stroke experience difficulties resuming their social or professional activities, which can lead to social and economic disruption (delayed/compromised return to work) and an increased risk of depression. While some care recommendations exist for this population, in France there is no consensus nor identified care pathway for follow-up assessment or management of these patients. Furthermore, existing services are unevenly distributed across the country, and research into the effectiveness of rehabilitation is still scarce, leading to uncertainty as to which interventions should be prioritized to decrease difficulties related to cognitive impairment.
Since there are currently no rehabilitation proposals in France for patients with mild cognitive impairment after mild stroke, in this trial the investigaror will investigate the effectiveness of two six-week telerehabilitation programs each consisting of a weekly session supervised by a therapist and a self-rehabilitation session. The aim of this multicenter randomized controlled trial is the evaluate the relevance and feasibility of early identification of patients eligible for a cognition-focused management proposal and the efficacy of two telecare programs, (a) psychoeducation and (b) computerized cognitive rehabilitation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients receiving the Psychoeducation Intervention | Experimental | Behavioral: PsychoeducationPatients will participate in a 6-week psychoeducation telerehabilitation intervention, that will consist of two 45-minute sessions per week. Each week they will participate in a 45-minute on-line session with a rehabilitation clinician and later in the week will complete 45 minutes of exercises set by the rehabilitation clinician |
| Patients receiving the Computerised Cognitive Stimulation Intervention | Experimental | Behavioral: Computerised Cognitive StimulationPatients will participate in a 6-week cognitive stimulation telerehabilitation intervention, that will consist of two 45-minute sessions per week. Each week they will participate in a 45-minute on-line session with a rehabilitation clinician and later in the week will complete 45 minutes of on-line exercises set by the rehabilitation clinician. |
| Patients receiving the Usual Care | Experimental | Behavioral: Usual CarePatients randomized to this group will complete the questionnaires and the cognitive tests but will receive no intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Man or woman, aged between 18 and 65 years old
- Hospitalization for a first stroke
- Minor stroke: NIHSS score < 5 on discharge from neurovascular unit
- Post-stroke delay < 8 weeks
- Living at home (not institutionalized)
Key exclusion criteria (12 listed)
- History of stroke
- Uncorrected hearing or visual impairment
- Neurological pathology other than stroke or disabling psychiatric disorder
- Unstabilized epilepsy
- Undergoing cognitive rehabilitation in another context or having integrated a post-stroke therapeutic education program
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 |
|---|---|---|
| PsychoeducationArm 1 : Psychoeducation aims to inform patients about post-stroke cognitive impairment, teach them coping strategies to compensate for these difficulties, provide information on symptom recognition and management, and offer emotional and psychological support to help them meet the challenges associated with these potential cognitive impairments. | Behavioural | Patients receiving the Psychoeducation Intervention |
| Computerised Cognitive StimulationArm 2 :Patients will participate in a 6-week cognitive stimulation telerehabilitation intervention, that will consist of two 45-minute sessions per week. Each week they will participate in a 45-minute on-line session with a rehabilitation clinician and later in the week will complete 45 minutes of on-line exercises set by the rehabilitation clinician | Behavioural | Patients receiving the Computerised Cognitive Stimulation Intervention |
| Usual CareArm 3 : No specific care. | Behavioural | Patients receiving the Usual Care |
Primary outcome
The primary objective of this study is to demonstrate the benefits of early management following a minor stroke on participation at 6 months post-stroke.
Time frame: At the end of the study : 36 months
Difference in the Participation score (from the Participation subscale of the stroke impact scale) between the pre-intervention evaluation and the evaluation 6 months post-stroke, between the intervention and non-intervention groups
8 secondary outcomes
to evaluate the effects on quality of life of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
Time frame: At the end of the study : 36 months
to evaluate the effects on cognitive complaint of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
Time frame: At the end of the study : 36 months
to evaluate the effects on cognitive function of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
Time frame: At the end of the study : 36 months
to evaluate the effects on mood and anxiety of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
Time frame: At the end of the study : 36 months
to evaluate the effects on fatigue of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
Time frame: At the end of the study : 36 months
to evaluate the effects on participation of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
Time frame: At the end of the study : 36 months
to evaluate the effects on health status of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
Time frame: At the end of the study : 36 months
to evaluate the effects on health status of the proposed programs at post-intervention, 6 months post-stroke and 9 months post-stroke in comparison with measurements taken before the start of management (pre-intervention visit 1)
Time frame: At the end of the study : 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2025.
- 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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation and Computerised Cognitive Stimulation in people with Minor Stroke, run by Hospices Civils de Lyon at 3 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 12 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: opening soon, as of the sponsor's last update on 18 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 PUGNIET Virginie (04.78.86.50.64, virginie.pugniet@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective of this study is to demonstrate the benefits of early management following a minor stroke on participation at 6 months post-stroke. (time frame: At the end of the study : 36 months). 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 18 Apr 2025.