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

Mindfulness Meditation Clinical Trial

— COREVALS  

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05409508
• Other study ID #: 2022-A01230-43
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: June 2023

Study information

• Verified date: May 2022
• Source: University Hospital, Angers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: June 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Amyotrophic Lateral Sclerosis
• Mindfulness Meditation
• Motor Neuron Disease
• Sclerosis

Intervention

Other:
• mindfulness meditation care
mindfulness meditation care
• no mindfulness meditation care
no mindfulness meditation care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Angers

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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