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

Primary Purpose

Parkinson Disease, Rest Tremor

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Mindfulness based stress reduction
Sponsored by
University Hospital, Montpellier
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Parkinson Disease focused on measuring parkinson disease, rest tremor, mindfulness based intervention, sensors, embrassment

Eligibility Criteria

35 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Montpellier University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Parkinson Mindfullness Based Stress Reduction

Parkinson controls

Arm Description

Patients who have an assessment before and after a mindfulness based stress reduction intervention for 6 months

Patients who have an assessment before and after 6 monthswithout intervention

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

duration of tremor assessed by agenda
Weekly cumulative time differences of tremor periods on Hauser's modified auto-diary (2000)
duration of tremor assessed by sensors monitoring
Weekly cumulative time differences of tremor periods recorded with the connected watch
feasability of the study : number of patients enrolled
- Proportion of patients included among screened patients
feasability of the study : number of patients ended the study
- Proportion of patients who completed the meditation program
feasability of the study : hours of recording of the tremor
- Proportion of hours of recording of the tremor compared to the planned duration
feasability of the study : tolerance
Tolerance to the meditation program assessed with a 10-point Likert scale
feasability of the study : COREQ 1
- Focus Groups Consolidated Criteria for Reporting on Qualitative Studies (COREQ) 1
Severity tremor index assessed by sensors monitoring
Differences in the Severity tremor index (mean amplitude of the tremor measured by the smartwatch)
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)
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.

Full Information

First Posted
October 29, 2021
Last Updated
March 24, 2023
Sponsor
University Hospital, Montpellier
Collaborators
Institut National de Recherche en Informatique et en Automatique, Université Montpellier
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1. Study Identification

Unique Protocol Identification Number
NCT05168046
Brief Title
Mindfulness-based Intervention for People With Parkinsonian Tremor
Acronym
MEDITAPARK
Official Title
Pilot Study of the Ambulatory Monitoring Evaluation of a Mindfulness Meditation Programme in Parkinsonian Tremor
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2021 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
Collaborators
Institut National de Recherche en Informatique et en Automatique, Université Montpellier

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Rest Tremor
Keywords
parkinson disease, rest tremor, mindfulness based intervention, sensors, embrassment

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parkinson Mindfullness Based Stress Reduction
Arm Type
Experimental
Arm Description
Patients who have an assessment before and after a mindfulness based stress reduction intervention for 6 months
Arm Title
Parkinson controls
Arm Type
No Intervention
Arm Description
Patients who have an assessment before and after 6 monthswithout intervention
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness based stress reduction
Intervention Description
program of weekly mindfulness based stress reduction intervention during 2 months and practice during 3 months
Primary Outcome Measure Information:
Title
Essential Tremor Embarrassment Assessment score
Description
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
Month 6 (M6)
Secondary Outcome Measure Information:
Title
duration of tremor assessed by agenda
Description
Weekly cumulative time differences of tremor periods on Hauser's modified auto-diary (2000)
Time Frame
Day 0 (inclusion), Month 3 (M3)
Title
duration of tremor assessed by sensors monitoring
Description
Weekly cumulative time differences of tremor periods recorded with the connected watch
Time Frame
Day 0 (inclusion), Month 3 (M3)
Title
feasability of the study : number of patients enrolled
Description
- Proportion of patients included among screened patients
Time Frame
Month 6 (M6)
Title
feasability of the study : number of patients ended the study
Description
- Proportion of patients who completed the meditation program
Time Frame
Month 6 (M6)
Title
feasability of the study : hours of recording of the tremor
Description
- Proportion of hours of recording of the tremor compared to the planned duration
Time Frame
Month 6 (M6)
Title
feasability of the study : tolerance
Description
Tolerance to the meditation program assessed with a 10-point Likert scale
Time Frame
Month 6 (M6)
Title
feasability of the study : COREQ 1
Description
- Focus Groups Consolidated Criteria for Reporting on Qualitative Studies (COREQ) 1
Time Frame
Month 6 (M6)
Title
Severity tremor index assessed by sensors monitoring
Description
Differences in the Severity tremor index (mean amplitude of the tremor measured by the smartwatch)
Time Frame
Month 3 (M3)
Title
Quality of life : Parkinson Disease Questionnaire 39 (PDQ39) scale
Description
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)
Title
Quality of life : Hamilton anxiety and depression scale (HADS)
Description
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.
Time Frame
Month 6 (M6)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christian GENY, MD
Phone
33665849416
Email
c-geny@chu-montpellier.fr
Facility Information:
Facility Name
Montpellier University Hospital
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian GENY, MD
Phone
33665849416
Email
c-geny@chu-montpellier.fr

12. IPD Sharing Statement

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Mindfulness-based Intervention for People With Parkinsonian Tremor

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