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)

University Hospital, Angers

Status: Unknown

Conditions: Mindfulness Meditation; Lateral Sclerosis Amyotrophy

Treatments: Other: mindfulness meditation care; Other: no mindfulness meditation care

Study type: Interventional

Funder types: Other

Identifiers

NCT05409508

2022-A01230-43

Details and patient eligibility

About

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).

Enrollment: 46 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups

Patients with mindfulness meditation care

Experimental group

Treatment:

Other: mindfulness meditation care

Patients without mindfulness meditation care

Active Comparator group

Treatment:

Other: no mindfulness meditation care