Mindfulness-based Intervention for People With Parkinsonian Tremor (MEDITAPARK)

Pilot Study of the Ambulatory Monitoring Evaluation of a Mindfulness Meditation Programme in Parkinsonian Tremor

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

Study Overview

• Status: Completed
• Conditions: Parkinson Disease; Rest Tremor
• Intervention / Treatment: Behavioral: Mindfulness based stress reduction

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Montpellier University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Parkinson disease
• Hoehn st and yahr stage <or = 3
• Age between 35 and 85 years old
• Treatment stabilized for at least 3 months
• Disturbing parkinsonian tremor of the upper limb (item MDS -UPDRS 2.10> 1) and lasting 2 to 6 hours per day
• patients with internet access

Exclusion Criteria:

• Presence of disturbing dyskinetic movements (Item MDS-UPDRS4.2> 1)
• Patient who has already practiced meditation in the last 5 years
• Untreated major depressive episode
• Hallucinations (Item MDS-UPDRS1.2> 1))
• Psychotic disorders - Confusional syndrome
• presence of signs in favor of an atypical parkinsonian syndrome (oculomotor impairment, early falls, hallucinations, MoCA <20, early dysautonomia)

• adult protected by law (guardianship, curatorship or under legal protection)

  • deprivation of liberty by judicial or administrative decision
  • high probability of non-compliance with the protocol or abandonment during the study
• refusal to sign informed consent
• Pregnant or breastfeeding woman
• Lack of social coverage.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Parkinson Mindfullness Based Stress Reduction; Patients who have an assessment before and after a mindfulness based stress reduction intervention for 6 months	Behavioral: Mindfulness based stress reduction; program of weekly mindfulness based stress reduction intervention during 2 months and practice during 3 months
No Intervention: Parkinson controls; Patients who have an assessment before and after 6 monthswithout intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Essential Tremor Embarrassment Assessment score	Essential Tremor Embarassment Assessment scale, ETEA : this scale is a self questionnaire made up of 14 items (0 to 5, 5 = worst embarrassment)	Month 6 (M6)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
duration of tremor assessed by agenda	Weekly cumulative time differences of tremor periods on Hauser's modified auto-diary (2000)	Day 0 (inclusion), Month 3 (M3)
duration of tremor assessed by sensors monitoring	Weekly cumulative time differences of tremor periods recorded with the connected watch	Day 0 (inclusion), Month 3 (M3)
feasability of the study : number of patients enrolled	- Proportion of patients included among screened patients	Month 6 (M6)
feasability of the study : number of patients ended the study	- Proportion of patients who completed the meditation program	Month 6 (M6)
feasability of the study : hours of recording of the tremor	- Proportion of hours of recording of the tremor compared to the planned duration	Month 6 (M6)
feasability of the study : tolerance	Tolerance to the meditation program assessed with a 10-point Likert scale	Month 6 (M6)
feasability of the study : COREQ 1	- Focus Groups Consolidated Criteria for Reporting on Qualitative Studies (COREQ) 1	Month 6 (M6)
Severity tremor index assessed by sensors monitoring	Differences in the Severity tremor index (mean amplitude of the tremor measured by the smartwatch)	Month 3 (M3)
Quality of life : Parkinson Disease Questionnaire 39 (PDQ39) scale	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)	Month 6 (M6)
Quality of life : Hamilton anxiety and depression scale (HADS)	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.	Month 6 (M6)

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Université Montpellier; Institut National de Recherche en Informatique et en Automatique

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): October 20, 2024
• Study Completion (Actual): October 20, 2024

Study Registration Dates

• First Submitted: October 29, 2021
• First Submitted That Met QC Criteria: December 21, 2021
• First Posted (Actual): December 23, 2021

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 24, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: sensors; rest tremor; parkinson disease; mindfulness based intervention; embrassment
• Additional Relevant MeSH Terms: Synucleinopathies; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Dyskinesias; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Parkinson Disease; Tremor; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness; Mindfulness-Based Stress Reduction
• Other Study ID Numbers: RECHMPL20_0321

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No