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 Purpose:

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).

Study Status:

Not yet recruiting

Disease:

Lateral Sclerosis Amyotrophy , Mindfulness Meditation

Study Type:

Interventional

Type of Intervention:

N/A

Intervention Name:

mindfulness meditation care, no mindfulness meditation care

Placebo:

Phase:

N/A

Study Chair(s)/Principal Investigator(s):

N/A

Clinicaltrials.gov ID:

NCT05409508

Neals Affiliated?

No

Coordinating Center Contact Information

Study Sponsor:

University Hospital, Angers

Estimated Enrollment:

46

Estimated Study Start Date:

09 / 01 / 2022

Estimated Study Completion Date:

06 / 01 / 2023

Posting Last Modified Date:

06 / 15 / 2022

Date Study Added to neals.org:

06 / 08 / 2022

Minimum Age:

18 Years

Maximum Age:

N/A

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