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 Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Lateral Sclerosis Amyotrophy, Mindfulness Meditation

Intervention / Treatment
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* Other: mindfulness meditation care
* Other: no mindfulness meditation care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with mindfulness meditation care<br> | Other: mindfulness meditation care<br>* mindfulness meditation care<br>|
| Active Comparator: Patients without mindfulness meditation care<br> | Other: no mindfulness meditation care<br>* no mindfulness meditation care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at 3 months |