Montpellier University Hospital
Montpellier, 34295, France
NCT Number: NCT05168046
Mindfulness meditation is an approach that has shown interest in treatment of anxiety in Parkinson's disease. This pilot study aims to assess a more specific effect on tremor using Essential Tremor Embarrassment Assessment and inertial sensors allowing monitoring during sessions and in daily life. This study will focus on 20 patients (10 with and without Mindfulness based intervention and will aim to develop the interface and demonstrate proof of concept before setting up a controlled study
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Notify Me35 year–85 year
All sexes
Interventional
Not applicable
Montpellier, 34295, France
Methodology: Randomized, pilot study comparing 2 parallel arms (Mindfullness group versus group with routine care).
Number of patients:20
Patient selection: patients with severe rest tremor
Duration of project: 12 months
Schedule visit: 4 visits in 6 months
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
program of weekly mindfulness based stress reduction intervention during 2 months and practice during 3 months
Time frame: Month 6 (M6)
Essential Tremor Embarassment Assessment scale, ETEA : this scale is a self questionnaire made up of 14 items (0 to 5, 5 = worst embarrassment)
Time frame: Day 0 (inclusion), Month 3 (M3)
Weekly cumulative time differences of tremor periods on Hauser's modified auto-diary (2000)
Time frame: Day 0 (inclusion), Month 3 (M3)
Weekly cumulative time differences of tremor periods recorded with the connected watch
Time frame: Month 6 (M6)
Time frame: Month 6 (M6)
Time frame: Month 6 (M6)
Time frame: Month 6 (M6)
Tolerance to the meditation program assessed with a 10-point Likert scale
Time frame: Month 6 (M6)
Time frame: Month 3 (M3)
Differences in the Severity tremor index (mean amplitude of the tremor measured by the smartwatch)
Time frame: Month 6 (M6)
The PDQ39 scale is a self questionnaire made up of 39 items exploring 8 dimensions (mobility, daily activities, emotionnal well-being, psychological incomfort, social support, cogntive disorders, communication, physical incomfort).
Description: Parkinson Disease Questionnaire 39 Quality of Life Score (PDQ39) (Auquier et al., 2002) - The PDQ-39 is a self-administered health-related Quality of Life (QOLL) instrument made up of 39 items exploring 8 dimensions (mobility , activity of daily living, emotional well-being, psychological discomfort, social support, cognitive disorders, communication, physical discomfort)
Time frame: Month 6 (M6)
Depression score: Hamilton Anxiety and Depression Scale (Leentjeens, 2011) - This questionnaire assesses the presence and severity of anxiety and depressive symptoms.
14 questions, answers between 0 and 3, total score between 0 and 42, 42 is the worse outcome.
University Hospital, Montpellier
Other
Pilot Study of the Ambulatory Monitoring Evaluation of a Mindfulness Meditation Programme in Parkinsonian Tremor
Acronym: MEDITAPARK
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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