Mindfulness-based Intervention for People With Parkinsonian Tremor

University Hospital, Montpellier21 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Parkinson Disease Rest Tremor

Interventions

Mindfulness based stress reductionBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 35 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (1)

Montpellier University Hospital

Montpellier, France

Outcomes

Primary Outcomes

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)

Time frame: Month 6 (M6)

Secondary Outcomes

duration of tremor assessed by agenda

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

Time frame: 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

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

feasability of the study : number of patients enrolled

\- Proportion of patients included among screened patients

Time frame: Month 6 (M6)

feasability of the study : number of patients ended the study

\- Proportion of patients who completed the meditation program

Time frame: 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

Time frame: Month 6 (M6)

feasability of the study : tolerance

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

Time frame: Month 6 (M6)

feasability of the study : COREQ 1

Data from ClinicalTrials.gov

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