Cognitive Stimulation for Elderly Bipolar Patients
TONIC
Evaluation of Cognitive Stimulation on Dysexecutive Residual Symptoms in Bipolar Patients Over 65 Years of Age
1 other identifier
interventional
40
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 29, 2019
CompletedFirst Posted
Study publicly available on registry
December 3, 2019
CompletedStudy Start
First participant enrolled
March 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 3, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
September 3, 2026
ExpectedMarch 17, 2025
March 1, 2025
5 years
November 29, 2019
March 13, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (20)
Score at FAB
at 6 months after inclusion
Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF)
at inclusion
Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF)
at 6 months after inclusion
Score at delayed matching-to-sample (DMS48)
at inclusion
Score at DMS48
at 3 months after inclusion
- +15 more secondary outcomes
Study Arms (2)
TONIC
EXPERIMENTALThe 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 INTERVENTIONThe usual practice consists of interviews with the psychiatrist with the possibility of home visits by the nurse.
Interventions
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.
Eligibility Criteria
You may qualify if:
- age \> 65 years old
- Diagnosis of bipolar illness for more than 10 years
- Euthymic phase
- Understands and speaks French
- Free, informed and express consent
- Mild to moderate neuro-cognitive impairments (MMS Test : 16 ≤ score \< 26)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Groupe Hospitalier de la Rochelle Ré Aunis
La Rochelle, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pascale Puzos, MD
Groupe Hospitalier de la Rochelle Ré Aunis
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2019
First Posted
December 3, 2019
Study Start
March 4, 2021
Primary Completion
March 3, 2026
Study Completion (Estimated)
September 3, 2026
Last Updated
March 17, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- CSR
- Time Frame
- Data will be made available with publication and up to 15 years after the end of the study
- Access Criteria
- On Mendeley repository A Digital Object Identifier will be provided
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.