Clinical trial NCT05409508: 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
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
Overall status: UNKNOWN
Phase: NA
Conditions: Lateral Sclerosis Amyotrophy
Mindfulness Meditation
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2022-06-08
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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).


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

Primary outcomes:
measure: 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
timeFrame: at 3 months
Secondary outcomes:
Other outcomes:
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