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

NCT ID: NCT05409508

Last Updated: 2022-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-30
• Study Completion Date: 2023-06-30

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).

Conditions

Lateral Sclerosis Amyotrophy; Mindfulness Meditation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Patients with mindfulness meditation care

Group Type: EXPERIMENTAL

mindfulness meditation care

Intervention Type: OTHER

mindfulness meditation care

Patients without mindfulness meditation care

Group Type: ACTIVE_COMPARATOR

no mindfulness meditation care

Intervention Type: OTHER

no mindfulness meditation care

Interventions

mindfulness meditation care

mindfulness meditation care

Intervention Type: OTHER

no mindfulness meditation care

no mindfulness meditation care

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Angers

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

2022-A01230-43

Identifier Type: -

Identifier Source: org_study_id