Hendaye

Researchers are evaluating the effects of auricular vagal neuromodulation therapy aVNT on adults with Prader-Willi Syndrome PWS, a rare neurodevelopmental disorder. The study aims to assess how daily aVNT stimulation impacts emotional control, executive functions such as planning and flexibility, hyperphagia, depression, and quality of life. This is the first multicenter randomized controlled trial exploring aVNT as a treatment for PWS, which currently has no therapies addressing its many behavioral and cognitive challenges. Participants will be randomly assigned to receive either active or sham aVNT stimulation using a small portable device with electrodes placed on the left ear. The stimulation sessions last four hours per day, seven days a week, over nine months. The device delivers painless electrical microcurrents to stimulate the auricular branch of the vagus nerve. Active stimulation is adjusted by participants for comfort and occurs during relaxing activities. The sham group uses the same device but with stimulation applied to an area without vagus nerve fibers. During the study, emotional control will be measured every two weeks for eleven months, including before and after the stimulation period. Other outcomes like executive functioning, hyperphagia, depression, and quality of life will be assessed four times before treatment, and at three, six, and nine months. Participants and their caregivers will be involved in evaluations. The study includes safety monitoring and aims to understand the persistence of effects after stimulation ends.

Researchers are exploring the experiences, needs, and expectations of family caregivers, including parents and siblings, of aging individuals with polyhandicap who are 35 years or older. Polyhandicap is a chronic condition involving profound intellectual disability and severe motor impairments, which significantly limits autonomy and communication. The study aims to better understand the social and emotional challenges faced by these caregivers as their relatives age, to improve support and assistance for these families. The study uses a mixed-methods approach combining quantitative questionnaires and qualitative interviews. Parents and siblings provide information through standardized self-reported questionnaires and interviews about quality of life, coping, emotional intelligence, and burden. Parents data were previously collected, while siblings data will be newly gathered via phone and mail. The study also integrates findings from multiple university and healthcare teams to analyze the experiences from both parents and siblings together. Participants will complete questionnaires and take part in interviews lasting about 30 to 60 minutes to share their experiences. Researchers will analyze these responses to understand family caregivers perspectives on aging relatives with polyhandicap. This includes comparing quantitative and qualitative data over a two-month period. The study helps identify specific caregiver needs and supports better transitions for families dealing with the aging process. Participation may involve filling booklets and engaging in interviews, with all information collected confidentially.