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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

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

Status
Withdrawn
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05409508
Acronym
COREVALS
Enrollment
0
Registered
2022-06-08
Start date
2022-05-01
Completion date
2023-06-01
Last updated
2026-06-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lateral Sclerosis Amyotrophy, Mindfulness Meditation

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).

Interventions

OTHERmindfulness meditation care

mindfulness meditation care

OTHERno mindfulness meditation care

no mindfulness meditation care

Sponsors

University Hospital, Angers
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 timeat 3 monthsfrom a quality of life scale : ALSSQOL-R : the lower the score, the more the person feels a sense of well-being

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jun 4, 2026