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

NCT05409508 | Unknown

• 1 other identifier: 2022-A01230-43
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Patients with mindfulness meditation care

EXPERIMENTAL

Other: mindfulness meditation care

Patients without mindfulness meditation care

ACTIVE COMPARATOR

Other: no mindfulness meditation care

Interventions

mindfulness meditation care OTHER

mindfulness meditation care

Patients with mindfulness meditation care

no mindfulness meditation care OTHER

no mindfulness meditation care

Patients without mindfulness meditation care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Angers: lead

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Motor Neuron Disease; Neurodegenerative Diseases; TDP-43 Proteinopathies; Neuromuscular Diseases; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2022
• First Posted: June 8, 2022
• Study Start: September 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: June 1, 2023
• Last Updated: June 15, 2022

Record last verified: 2022-05