Bipolar DisorderTONICNCT04184375
Cognitive Stimulation for Elderly Bipolar Patients
A study testing cognitive stimulation in people with Bipolar Disorder and Cognitive Impairment, run by Groupe Hospitalier de la Rochelle Ré Aunis at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Bipolar Disorder, Cognitive Impairment, Age-related Cognitive Decline
- What is being tested?
- cognitive stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2021to 3 Sep 2026
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Mild to moderate neuro-cognitive impairments (MMS Test : 16 ≤ score < 26)
Who cannot join
- Illiteracy
- Patient participating in other therapeutic workshops (e. g. psycho-geriatric day hospital care, etc.)
- Persons deprived of their liberty by a judicial or administrative decision
- Persons of full age who are subject to a legal protection measure
- Persons unable to consent
- Persons who are not members of or beneficiaries of a social security scheme
- Patient's refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle
Pascale Puzos, MD
Cécile DUFRESNE
About this study
Official title: Evaluation of Cognitive Stimulation on Dysexecutive Residual Symptoms in Bipolar Patients Over 65 Years of Age
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.
Read the detailed description
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.
- Being tested
- cognitive stimulation
- Medical subject headings
- Bipolar Disorder, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cognitive stimulationBehavioural
Patients participate in one session per week according to the following schedule:
- 2 sensory stimulation sessions: identify sensations, emotions, how to manage them.
- 2 sessions on association, verbal fluency, and imagination: language as a tool for expression in the face of illness.
- 2 voluntary attention sessions: improve daily attention.
- 2 sessions of intellectual structuring: stimulating and maintaining memory, carrying out external activities.
- 2 sessions of structuring through language: impact on social life.
- 2 sessions stimulating the temporal and spatial landmarks: agenda, daily trips.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: cognitive stimulation |
| Control | No intervention | The usual practice consists of interviews with the psychiatrist with the possibility of home visits by the nurse. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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")
Measured: at 3 months after inclusion
Secondary outcomes (20)
Score at FAB
Scores between the 3-month and 6-month evaluation will determine whether executive analysis functions have been maintained
Measured: at 6 months after inclusion
Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF)
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.
Measured: 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
Measured: at 6 months after inclusion
Score at delayed matching-to-sample (DMS48)
The DMS48 is a test of visual recognition memory test
Measured: at inclusion
Score at DMS48
The DMS48 is a test of visual recognition memory test
Measured: at 3 months after inclusion
Time in minutes at the Trail Making Test A (TMTA)
Evaluation of speed of processing.
Measured: at inclusion
Time in minutes at the Trail Making Test A
Evaluation of speed of processing.
Measured: at 3 months after inclusion
Number of errors at Trail Making Test B (TMTB)
Evaluation of mental flexibility
Measured: at inclusion
Number of errors at Trail Making Test B (TMTB)
Evaluation of mental flexibility
Measured: at 3 months after inclusion
Score at ISAAC test
Measures fluence
Measured: at inclusion
Score at ISAAC test
Measures fluence
Measured: at 3 months after inclusion
Score at Montreal Cognitive Assessment (MMS)
Assessment for detecting cognitive impairment
Measured: at inclusion
Score at Montreal Cognitive Assessment (MMS)
Assessment for detecting cognitive impairment
Measured: at 6 months after inclusion
Score at the Hamilton Depression Rating Scale
Evaluation of patient thymic state
Measured: at inclusion
Score at the Hamilton Depression Rating Scale
Evaluation of patient thymic state
Measured: at 6 months after inclusion
Interference score at the Stroop test
Evaluation of selective attention
Measured: at inclusion
Interference score at the Stroop test
Evaluation of selective attention
Measured: at 6 months after inclusion
Number of hospitalization due to relapse
hospitalization due to relapse
Measured: 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
Measured: 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
Measured: at 6 months after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2019
- Study start4 Mar 2021
- Primary completion3 Mar 2026 (estimated)
- Study completion3 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré Aunis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pascale Puzos, MD, Study director, Groupe Hospitalier de la Rochelle Ré Aunis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184375
- Sponsor's protocol ID
- 2015/P05/095
- Acronym
- TONIC
- Status last verified
- Mar 2025
- First submitted
- 29 Nov 2019
- Last updated
- 17 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cognitive Stimulation on Dysexecutive Residual Symptoms in Bipolar Patients Over 65 Years of Age
- ClinicalTrials.gov ID
- NCT04184375
- Acronym / sponsor ID
- TONIC / 2015/P05/095
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Groupe Hospitalier de la Rochelle Ré AunisUniversity, hospital or other
- Study start
- 4 Mar 2021 (actual)
- Primary completion
- 3 Mar 2026 (estimated)
- Study completion
- 3 Sep 2026 (estimated)
- First posted
- 3 Dec 2019 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TONIC | Experimental | Behavioral: cognitive stimulationThe 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. |
| Control | No intervention | –The usual practice consists of interviews with the psychiatrist with the possibility of home visits by the nurse. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Mild to moderate neuro-cognitive impairments (MMS Test : 16 ≤ score < 26)
Key exclusion criteria (7 listed)
- Illiteracy
- Patient participating in other therapeutic workshops (e. g. psycho-geriatric day hospital care, etc.)
- Persons deprived of their liberty by a judicial or administrative decision
- Persons of full age who are subject to a legal protection measure
- Persons unable to consent
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 |
|---|---|---|
| cognitive stimulationPatients participate in one session per week according to the following schedule: * 2 sensory stimulation sessions: identify sensations, emotions, how to manage them. * 2 sessions on association, verbal fluency, and imagination: language as a tool for expression in the face of illness. * 2 voluntary attention sessions: improve daily attention. * 2 sessions of intellectual structuring: stimulating and maintaining memory, carrying out external activities. * 2 sessions of structuring through language: impact on social life. * 2 sessions stimulating the temporal and spatial landmarks: agenda, daily trips. | Behavioural | TONIC |
Primary outcome
Score at the Frontal Assessment Battery (FAB)
Time frame: at 3 months after inclusion
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")
20 secondary outcomes
Score at FAB
Time frame: at 6 months after inclusion
Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF)
Time frame: at inclusion
Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF)
Time frame: at 6 months after inclusion
Score at delayed matching-to-sample (DMS48)
Time frame: at inclusion
Score at DMS48
Time frame: at 3 months after inclusion
Time in minutes at the Trail Making Test A (TMTA)
Time frame: at inclusion
Time in minutes at the Trail Making Test A
Time frame: at 3 months after inclusion
Number of errors at Trail Making Test B (TMTB)
Time frame: at inclusion
Number of errors at Trail Making Test B (TMTB)
Time frame: at 3 months after inclusion
Score at ISAAC test
Time frame: at inclusion
Score at ISAAC test
Time frame: at 3 months after inclusion
Score at Montreal Cognitive Assessment (MMS)
Time frame: at inclusion
Score at Montreal Cognitive Assessment (MMS)
Time frame: at 6 months after inclusion
Score at the Hamilton Depression Rating Scale
Time frame: at inclusion
Score at the Hamilton Depression Rating Scale
Time frame: at 6 months after inclusion
Interference score at the Stroop test
Time frame: at inclusion
Interference score at the Stroop test
Time frame: at 6 months after inclusion
Number of hospitalization due to relapse
Time frame: at 6 months after inclusion
Score at Zarit scale (caregiver)
Time frame: at inclusion
Score at Zarit scale (caregiver)
Time frame: at 6 months after inclusion
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 17 Mar 2025.
- Individual participant dataSharing planned: Yes. 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.
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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.
Pascale Puzos, MD study director
Groupe Hospitalier de la Rochelle Ré Aunis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cognitive stimulation in people with Bipolar Disorder and Cognitive Impairment, run by Groupe Hospitalier de la Rochelle Ré Aunis 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 1 inclusion and 7 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 17 Mar 2025. 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?
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 Caroline ALLIX-BEGUEC, Ph.D. (+33 (0) 516 49 42 46, caroline.allix-beguec@ght-atlantique17.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score at the Frontal Assessment Battery (FAB) (time frame: at 3 months after inclusion). 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 17 Mar 2025.