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Completed

NCT Number: NCT05168046

Mindfulness-based Intervention for People With 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

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Key information

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montpellier University Hospital

Montpellier, 34295, France

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness Based Stress Reduction

Behavioral

program of weekly mindfulness based stress reduction intervention during 2 months and practice during 3 months

Primary outcomes

  1. Essential Tremor Embarrassment Assessment score

    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)

Secondary outcomes

  1. duration of tremor assessed by agenda

    Time frame: Day 0 (inclusion), Month 3 (M3)

    Weekly cumulative time differences of tremor periods on Hauser's modified auto-diary (2000)

  2. duration of tremor assessed by sensors monitoring

    Time frame: Day 0 (inclusion), Month 3 (M3)

    Weekly cumulative time differences of tremor periods recorded with the connected watch

  3. feasability of the study : number of patients enrolled

    Time frame: Month 6 (M6)

    • Proportion of patients included among screened patients
  4. feasability of the study : number of patients ended the study

    Time frame: Month 6 (M6)

    • Proportion of patients who completed the meditation program
  5. feasability of the study : hours of recording of the tremor

    Time frame: Month 6 (M6)

    • Proportion of hours of recording of the tremor compared to the planned duration
  6. feasability of the study : tolerance

    Time frame: Month 6 (M6)

    Tolerance to the meditation program assessed with a 10-point Likert scale

  7. feasability of the study : COREQ 1

    Time frame: Month 6 (M6)

    • Focus Groups Consolidated Criteria for Reporting on Qualitative Studies (COREQ) 1
  8. Severity tremor index assessed by sensors monitoring

    Time frame: Month 3 (M3)

    Differences in the Severity tremor index (mean amplitude of the tremor measured by the smartwatch)

  9. Quality of life : Parkinson Disease Questionnaire 39 (PDQ39) scale

    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)

  10. Quality of life : Hamilton anxiety and depression scale (HADS)

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Institut National de Recherche en Informatique et en Automatique
  • Université Montpellier

Registry information

Official study title

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

Acronym: MEDITAPARK

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 23, 2021
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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