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Age is a major risk factor for the development of cognitive disorders and neurodegenerative pathologies. Cognitive disorders during the phases of bipolar disease are known to exist, and alterations increase significantly after the age of 65. Drug treatments seem to have only a limited effect. A cognitive stimulation program has proven his benefit to patients over 65 with neurodegenerative diseases (Israel, 2004). We propose to evaluate this cognitive stimulation program that we have adapted to bipolar disease.
Bipolar disorders, which belong to the category of mood disorders, are the 6th leading cause of disability in the world. Cognitive disorders are known to exist during the phases of bipolar disease, and alterations increase significantly after the age of 65. Recent studies have shown that attention, memory and executive function impairments are the main causes of cognitive disorders. Residual symptoms have a significant impact on the risk of relapse into bipolar disorder and on quality of life. Cognitive stimulation (CS) is a pedagogical approach based on the idea that cognitive skills contribute to personal development in the same way as psychological and social factors. This study aims at assessing a cognitive stimulation program initially developed for patients with neurodegenerative diseases, and adapted to bipolar disease. This program will be compared to the usual practice consisting in consultation with psychiatrist and sometimes in intervention of home nurses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TONIC | Experimental | The cognitive stimulation sessions are carried out using Liliane Israël's "TRAIN YOUR MEMORY" software, and are divided into two parts: the first part is essentially cognitive and the second relates to the daily life of the Bipolar patient. This training method consists of combining two means of intervention, pedagogical action and psychotherapeutic effect. It aims to stimulate, develop and strengthen the basic mechanisms underlying memory phenomena (sensory acuity, attention, associations, structuring, executive functions, spatial and temporal landmarks, associative recruitment). It is presented in the form of exercises divided into eight modules. |
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| Control | No Intervention | The usual practice consists of interviews with the psychiatrist with the possibility of home visits by the nurse. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cognitive stimulation | Behavioral | Patients participate in one session per week according to the following schedule:
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| Measure | Description | Time Frame |
|---|---|---|
| Score at the Frontal Assessment Battery (FAB) | The FAB assesses conceptualization (category responses, such as "in what way are a banana and an orange are alike?"), lexical fluency, programming or motor series (Luria), sensitivity to interference (conflicting instructions, such as "tap twice when I tap once"), inhibitory control (Go/No-Go), and environmental autonomy (prehension behavior, such as "do not take my hands") | at 3 months after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Score at FAB | Scores between the 3-month and 6-month evaluation will determine whether executive analysis functions have been maintained | at 6 months after inclusion |
| Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF) |
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Pre-Inclusion Criteria:
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline ALLIX-BEGUEC, Ph.D. | Contact | +33 (0) 516 49 42 46 | caroline.allix-beguec@ght-atlantique17.fr |
| Name | Affiliation | Role |
|---|---|---|
| Pascale Puzos, MD | Groupe Hospitalier de la Rochelle Ré Aunis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier de la Rochelle Ré Aunis | Recruiting | La Rochelle | France |
Data will be made available with publication. A Digital Object Identifier will be used.
Keyword are bipolar disorder, aged, cognitive dysfunction, cognitive Remediation.
The only available version will be the locked database. With the exception of dates, all data will be made available. Dates will only be collected to verify the quality of the clinical trial execution. They do not add to the clinical question, and may be a means of indirectly identifying patients. The database will be made available through Mendeley Data.
Medical Subject Headings (MESH) terms will be used to describe clinical data. Psychological test references will be provided in the publication. International standard unit will be used. The data will be made available to the community of scientists and clinicians interested in bipolar disorder.
Data will be made available with the free access to the publication for 15 years.
Data will be made available with publication and up to 15 years after the end of the study
On Mendeley repository A Digital Object Identifier will be provided
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 11, 2026 | |
| Reset | Mar 30, 2026 | |
| Release | Apr 16, 2026 | |
| Reset | May 6, 2026 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 11, 2026 | Mar 30, 2026 | |||
| Apr 16, 2026 |
| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
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The QAF allows to quickly assess a patient's functional capacity and to identify a functional decline in the patient with a mild neurocognitive disorder, Alzheimer's disease or other neurocognitive disorder. |
| at inclusion |
| Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF) | A positive difference in scores reflects an improvement in patient autonomy | at 6 months after inclusion |
| Score at delayed matching-to-sample (DMS48) | The DMS48 is a test of visual recognition memory test | at inclusion |
| Score at DMS48 | The DMS48 is a test of visual recognition memory test | at 3 months after inclusion |
| Time in minutes at the Trail Making Test A (TMTA) | Evaluation of speed of processing. | at inclusion |
| Time in minutes at the Trail Making Test A | Evaluation of speed of processing. | at 3 months after inclusion |
| Number of errors at Trail Making Test B (TMTB) | Evaluation of mental flexibility | at inclusion |
| Number of errors at Trail Making Test B (TMTB) | Evaluation of mental flexibility | at 3 months after inclusion |
| Score at ISAAC test | Measures fluence | at inclusion |
| Score at ISAAC test | Measures fluence | at 3 months after inclusion |
| Score at Montreal Cognitive Assessment (MMS) | Assessment for detecting cognitive impairment | at inclusion |
| Score at Montreal Cognitive Assessment (MMS) | Assessment for detecting cognitive impairment | at 6 months after inclusion |
| Score at the Hamilton Depression Rating Scale | Evaluation of patient thymic state | at inclusion |
| Score at the Hamilton Depression Rating Scale | Evaluation of patient thymic state | at 6 months after inclusion |
| Interference score at the Stroop test | Evaluation of selective attention | at inclusion |
| Interference score at the Stroop test | Evaluation of selective attention | at 6 months after inclusion |
| Number of hospitalization due to relapse | hospitalization due to relapse | at 6 months after inclusion |
| Score at Zarit scale (caregiver) | Identification of suffering or exhaustion, anxiety and/or depressive disorder(s), sleep disorder(s), etc. in the caregiver | at inclusion |
| Score at Zarit scale (caregiver) | Identification of suffering or exhaustion, anxiety and/or depressive disorder(s), sleep disorder(s), etc. in the caregiver | at 6 months after inclusion |
| May 6, 2026 |
| D019965 |
| Neurocognitive Disorders |