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:
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