Clinical trial NCT05168046: Mindfulness-based Intervention for People with Parkinsonian Tremor
Official title: Pilot Study of the Ambulatory Monitoring Evaluation of a Mindfulness Meditation Programme in Parkinsonian Tremor
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Rest Tremor
Keywords: parkinson disease
rest tremor
mindfulness based intervention
sensors
embrassment
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Institut National de Recherche en Informatique et en Automatique
name: Université Montpellier
First posted: 2021-12-23
Enrollment: 21
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

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.

Primary outcomes:
measure: Essential Tremor Embarrassment Assessment score
timeFrame: Month 6 (M6)
Secondary outcomes:
measure: duration of tremor assessed by agenda
timeFrame: Day 0 (inclusion), Month 3 (M3)
measure: duration of tremor assessed by sensors monitoring
timeFrame: Day 0 (inclusion), Month 3 (M3)
measure: feasability of the study : number of patients enrolled
timeFrame: Month 6 (M6)
measure: feasability of the study : number of patients ended the study
timeFrame: Month 6 (M6)
measure: feasability of the study : hours of recording of the tremor
timeFrame: Month 6 (M6)
measure: feasability of the study : tolerance
timeFrame: Month 6 (M6)
measure: feasability of the study : COREQ 1
timeFrame: Month 6 (M6)
measure: Severity tremor index assessed by sensors monitoring
timeFrame: Month 3 (M3)
measure: Quality of life : Parkinson Disease Questionnaire 39 (PDQ39) scale
timeFrame: Month 6 (M6)
measure: Quality of life : Hamilton anxiety and depression scale (HADS)
timeFrame: Month 6 (M6)
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Montpellier University Hospital
Study officials:
References: