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NCT Number: NCT04184375

Cognitive Stimulation for Elderly Bipolar Patients

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.

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Key information

Conditions

Bipolar Disorder Age-related Cognitive Decline Bipolar and Related Disorders Cognition Disorders Cognitive Dysfunction Cognitive Impairment Mental Disorders Mood Disorders Neurocognitive Disorders

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Groupe Hospitalier de la Rochelle Ré Aunis

La Rochelle, France

Location status: Recruiting

Location contact

Caroline DURAND

PRINCIPAL_INVESTIGATOR

Cécile DUFRESNE

PRINCIPAL_INVESTIGATOR

Damien CLUS

PRINCIPAL_INVESTIGATOR

Edouard BARUCQ

PRINCIPAL_INVESTIGATOR

Emmanuelle TEYSSEDRE

PRINCIPAL_INVESTIGATOR

Louise LARROQUE

PRINCIPAL_INVESTIGATOR

Marion COULON

PRINCIPAL_INVESTIGATOR

Pascale Puzos, MD

CONTACT

Sophie DEVAUCHELLE

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cognitive stimulation

Behavioral

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.

Primary outcomes

  1. 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")

Secondary outcomes

  1. Score at FAB

    Time frame: at 6 months after inclusion

    Scores between the 3-month and 6-month evaluation will determine whether executive analysis functions have been maintained

  2. Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF)

    Time frame: at inclusion

    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.

  3. Number of patients with a positive difference between the scores on the Functional Activities Questionnaire (QAF)

    Time frame: at 6 months after inclusion

    A positive difference in scores reflects an improvement in patient autonomy

  4. Score at delayed matching-to-sample (DMS48)

    Time frame: at inclusion

    The DMS48 is a test of visual recognition memory test

  5. Score at DMS48

    Time frame: at 3 months after inclusion

    The DMS48 is a test of visual recognition memory test

  6. Time in minutes at the Trail Making Test A (TMTA)

    Time frame: at inclusion

    Evaluation of speed of processing.

  7. Time in minutes at the Trail Making Test A

    Time frame: at 3 months after inclusion

    Evaluation of speed of processing.

  8. Number of errors at Trail Making Test B (TMTB)

    Time frame: at inclusion

    Evaluation of mental flexibility

  9. Number of errors at Trail Making Test B (TMTB)

    Time frame: at 3 months after inclusion

    Evaluation of mental flexibility

  10. Score at ISAAC test

    Time frame: at inclusion

    Measures fluence

  11. Score at ISAAC test

    Time frame: at 3 months after inclusion

    Measures fluence

  12. Score at Montreal Cognitive Assessment (MMS)

    Time frame: at inclusion

    Assessment for detecting cognitive impairment

  13. Score at Montreal Cognitive Assessment (MMS)

    Time frame: at 6 months after inclusion

    Assessment for detecting cognitive impairment

  14. Score at the Hamilton Depression Rating Scale

    Time frame: at inclusion

    Evaluation of patient thymic state

  15. Score at the Hamilton Depression Rating Scale

    Time frame: at 6 months after inclusion

    Evaluation of patient thymic state

  16. Interference score at the Stroop test

    Time frame: at inclusion

    Evaluation of selective attention

  17. Interference score at the Stroop test

    Time frame: at 6 months after inclusion

    Evaluation of selective attention

  18. Number of hospitalization due to relapse

    Time frame: at 6 months after inclusion

    hospitalization due to relapse

  19. Score at Zarit scale (caregiver)

    Time frame: at inclusion

    Identification of suffering or exhaustion, anxiety and/or depressive disorder(s), sleep disorder(s), etc. in the caregiver

  20. Score at Zarit scale (caregiver)

    Time frame: at 6 months after inclusion

    Identification of suffering or exhaustion, anxiety and/or depressive disorder(s), sleep disorder(s), etc. in the caregiver

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline ALLIX-BEGUEC, Ph.D.

CONTACT

[email protected]

+33 (0) 516 49 42 46

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier de la Rochelle Ré Aunis

Other

Registry information

Official study title

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

Acronym: TONIC

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 3, 2019
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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