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Cognitive Stimulation for Elderly Bipolar Patients

Evaluation of Cognitive Stimulation on Dysexecutive Residual Symptoms in Bipolar Patients Over 65 Years of Age

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04184375
Acronym
TONIC
Enrollment
40
Registered
2019-12-03
Start date
2021-03-04
Completion date
2026-09-03
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Cognitive Decline, Bipolar Disorder, Cognitive Impairment

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.

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.

Interventions

BEHAVIORALcognitive stimulation

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.

Sponsors

Groupe Hospitalier de la Rochelle Ré Aunis
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Pre-Inclusion Criteria: * age \> 65 years old * Diagnosis of bipolar illness for more than 10 years * Euthymic phase * Understands and speaks French * Free, informed and express consent Inclusion Criteria: * Mild to moderate neuro-cognitive impairments (MMS Test : 16 ≤ score \< 26)

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Score at the Frontal Assessment Battery (FAB)at 3 months after inclusionThe 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)

Secondary

MeasureTime frameDescription
Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF)at inclusionThe 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.
Score at delayed matching-to-sample (DMS48)at inclusionThe DMS48 is a test of visual recognition memory test
Score at DMS48at 3 months after inclusionThe DMS48 is a test of visual recognition memory test
Time in minutes at the Trail Making Test A (TMTA)at inclusionEvaluation of speed of processing.
Time in minutes at the Trail Making Test Aat 3 months after inclusionEvaluation of speed of processing.
Number of errors at Trail Making Test B (TMTB)at inclusionEvaluation of mental flexibility
Score at FABat 6 months after inclusionScores between the 3-month and 6-month evaluation will determine whether executive analysis functions have been maintained
Score at Montreal Cognitive Assessment (MMS)at inclusionAssessment for detecting cognitive impairment
Score at the Hamilton Depression Rating Scaleat inclusionEvaluation of patient thymic state
Interference score at the Stroop testat inclusionEvaluation of selective attention
Number of hospitalization due to relapseat 6 months after inclusionhospitalization due to relapse
Score at Zarit scale (caregiver)at inclusionIdentification of suffering or exhaustion, anxiety and/or depressive disorder(s), sleep disorder(s), etc. in the caregiver
Score at ISAAC testat inclusionMeasures fluence

Countries

France

Contacts

Primary ContactCaroline ALLIX-BEGUEC, Ph.D.
caroline.allix-beguec@ght-atlantique17.fr+33 (0) 516 49 42 46

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026