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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 (COREVALS)

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ClinicalTrials.gov Identifier: NCT05409508
Recruitment Status : Not yet recruiting
First Posted : June 8, 2022
Last Update Posted : June 15, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
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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).

Condition or disease Intervention/treatment Phase
Lateral Sclerosis Amyotrophy Mindfulness Meditation Other: mindfulness meditation care Other: no mindfulness meditation care Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Estimated Study Start Date : September 2022
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with mindfulness meditation care Other: mindfulness meditation care
mindfulness meditation care
Active Comparator: Patients without mindfulness meditation care Other: no mindfulness meditation care
no mindfulness meditation care


Outcome Measures
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Primary Outcome Measures :
  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 [ Time Frame: at 3 months ]
    from a quality of life scale : ALSSQOL-R : the lower the score, the more the person feels a sense of well-being


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT05409508    
Other Study ID Numbers: 2022-A01230-43
First Posted: June 8, 2022    Key Record Dates
Last Update Posted: June 15, 2022
Last Verified: May 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Motor Neuron Disease
Amyotrophic Lateral Sclerosis
Sclerosis
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
 Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases