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Psychological Management by Meditation of Full COnscience in Virtual REality of People With Amyotrophic Lateral Sclerosis: Effects on Cognition, Behavior, Quality of Life and Psychological Well-being (COREVALS)

Primary Purpose

Lateral Sclerosis Amyotrophy, Mindfulness Meditation

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
mindfulness meditation care
no mindfulness meditation care
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lateral Sclerosis Amyotrophy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Majors to inclusion
  • Mother tongue: French
  • Patients for whom ALS of bulbar or spinal form defined according to El Escorial criteria is possible, probable or certain
  • Able to carry out the investigations and interventions provided for in the protocol
  • Signature of informed consent to participate in the study

Exclusion Criteria:

  • Participation in intervention research modifying management
  • History likely to disrupt cognition (constituted stroke, sequelae of traumatic brain injury, active epilepsy, learning disabilities, alcohol dependence syndrome, drug use, psychiatric disorders), severe cognitive impairment (MMSE <24)
  • People who meet the diagnostic criteria for Frontotemporal Dementia
  • Pregnant or lactating women
  • Persons deprived of their liberty by administrative or judicial decision
  • Persons undergoing psychiatric care under duress
  • Persons subject to a legal protection measure
  • Persons unable to express their consent
  • Persons not affiliated or not beneficiaries of a social security scheme

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Patients with mindfulness meditation care

    Patients without mindfulness meditation care

    Arm Description

    Outcomes

    Primary Outcome Measures

    To assess the benefits of psychological care with mindfulness meditation in virtual reality versus psychological management without mindfulness meditation in virtual reality in terms of evolution over time
    from a quality of life scale : ALSSQOL-R : the lower the score, the more the person feels a sense of well-being

    Secondary Outcome Measures

    Full Information

    First Posted
    May 30, 2022
    Last Updated
    June 10, 2022
    Sponsor
    University Hospital, Angers
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05409508
    Brief Title
    Psychological Management by Meditation of Full COnscience in Virtual REality of People With Amyotrophic Lateral Sclerosis: Effects on Cognition, Behavior, Quality of Life and Psychological Well-being
    Acronym
    COREVALS
    Official Title
    Psychological Management by Meditation of Full COnscience in Virtual REality of People With Amyotrophic Lateral Sclerosis: Effects on Cognition, Behavior, Quality of Life and Psychological Well-being
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2022 (Anticipated)
    Primary Completion Date
    May 2023 (Anticipated)
    Study Completion Date
    June 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Angers

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Amyotrophic lateral sclerosis (ALS) is a neurodegenerative disease that results in progressive paralysis of the muscles involved in voluntary motor skills, speech, swallowing and breathing. It also causes non-motor symptoms including psychological, cognitive and behavioral difficulties that have a negative impact on patients' quality of life, well-being and long-term development. There is no curative therapy for ALS and drug treatments have little effect on non-motor symptoms. Interventions based on mindfulness meditation, defined as a state of consciousness that arises when one decides to focus attention in the present moment without judgment on the real experience, seem to be a promising tool for the reduction of non-motor symptoms in a number of progressive neurological conditions (Alzheimer's disease, multiple sclerosis, etc.), suggesting that mindfulness significantly helps in the management of these symptoms. Our project therefore aims to implement a mindfulness meditation program adapted to the management of non-motor symptoms in ALS based on virtual reality (VR).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Lateral Sclerosis Amyotrophy, Mindfulness Meditation

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    46 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Patients with mindfulness meditation care
    Arm Type
    Experimental
    Arm Title
    Patients without mindfulness meditation care
    Arm Type
    Active Comparator
    Intervention Type
    Other
    Intervention Name(s)
    mindfulness meditation care
    Intervention Description
    mindfulness meditation care
    Intervention Type
    Other
    Intervention Name(s)
    no mindfulness meditation care
    Intervention Description
    no mindfulness meditation care
    Primary Outcome Measure Information:
    Title
    To assess the benefits of psychological care with mindfulness meditation in virtual reality versus psychological management without mindfulness meditation in virtual reality in terms of evolution over time
    Description
    from a quality of life scale : ALSSQOL-R : the lower the score, the more the person feels a sense of well-being
    Time Frame
    at 3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Majors to inclusion Mother tongue: French Patients for whom ALS of bulbar or spinal form defined according to El Escorial criteria is possible, probable or certain Able to carry out the investigations and interventions provided for in the protocol Signature of informed consent to participate in the study Exclusion Criteria: Participation in intervention research modifying management History likely to disrupt cognition (constituted stroke, sequelae of traumatic brain injury, active epilepsy, learning disabilities, alcohol dependence syndrome, drug use, psychiatric disorders), severe cognitive impairment (MMSE <24) People who meet the diagnostic criteria for Frontotemporal Dementia Pregnant or lactating women Persons deprived of their liberty by administrative or judicial decision Persons undergoing psychiatric care under duress Persons subject to a legal protection measure Persons unable to express their consent Persons not affiliated or not beneficiaries of a social security scheme

    12. IPD Sharing Statement

    Learn more about this trial

    Psychological Management by Meditation of Full COnscience in Virtual REality of People With Amyotrophic Lateral Sclerosis: Effects on Cognition, Behavior, Quality of Life and Psychological Well-being

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