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
About this trial
This is an interventional other trial for Lateral Sclerosis Amyotrophy
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
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
NCT ID
NCT05409508
First Posted
May 30, 2022
Last Updated
June 10, 2022
Sponsor
University Hospital, Angers
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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