Mindfulness-based Intervention for People with Parkinsonian Tremor

Not Applicable

Completed

• Conditions: Parkinson Disease; Rest Tremor
• Interventions: Behavioral: Mindfulness based stress reduction

• Registration Number: NCT05168046
• Lead Sponsor: University Hospital, Montpellier

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

Study Timeline

• Study First Submitted: 2021-10-29
• Study Start: 2021-11-15
• Study First Submitted QC: 2021-12-21
• Study First Posted: 2021-12-23
• Primary Completion: 2024-10-20
• Study Completion: 2024-10-20
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-13
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parkinson Mindfullness Based Stress Reduction	Mindfulness based stress reduction	Patients who have an assessment before and after a mindfulness based stress reduction intervention for 6 months

Primary Outcome Measures

Name	Time	Method
Essential Tremor Embarrassment Assessment score	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 Outcome Measures

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

Trial Locations

Locations (1)

Montpellier University Hospital; 🇫🇷 Montpellier, France