Mindfulness-based Intervention for People With Parkinsonian Tremor

Parkinson Disease Clinical Trial

— MEDITAPARK  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05168046
• Other study ID #: RECHMPL20_0321 UF 7999
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: November 2024

Study information

• Verified date: May 2024
• Source: University Hospital, Montpellier
• Contact: Christian GENY, MD
• Phone: 33665849416
• Email: c-geny[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: November 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease
• Rest Tremor
• Tremor

Intervention

Behavioral:
• Mindfulness based stress reduction
program of weekly mindfulness based stress reduction intervention during 2 months and practice during 3 months

Locations

Country	Name	City	State
France	Montpellier University Hospital	Montpellier

Sponsors (3)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Institut National de Recherche en Informatique et en Automatique, Université Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Month 6 (M6)
Secondary	duration of tremor assessed by agenda	Weekly cumulative time differences of tremor periods on Hauser's modified auto-diary (2000)	Day 0 (inclusion), Month 3 (M3)
Secondary	duration of tremor assessed by sensors monitoring	Weekly cumulative time differences of tremor periods recorded with the connected watch	Day 0 (inclusion), Month 3 (M3)
Secondary	feasability of the study : number of patients enrolled	- Proportion of patients included among screened patients	Month 6 (M6)
Secondary	feasability of the study : number of patients ended the study	- Proportion of patients who completed the meditation program	Month 6 (M6)
Secondary	feasability of the study : hours of recording of the tremor	- Proportion of hours of recording of the tremor compared to the planned duration	Month 6 (M6)
Secondary	feasability of the study : tolerance	Tolerance to the meditation program assessed with a 10-point Likert scale	Month 6 (M6)
Secondary	feasability of the study : COREQ 1	- Focus Groups Consolidated Criteria for Reporting on Qualitative Studies (COREQ) 1	Month 6 (M6)
Secondary	Severity tremor index assessed by sensors monitoring	Differences in the Severity tremor index (mean amplitude of the tremor measured by the smartwatch)	Month 3 (M3)
Secondary	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)	Month 6 (M6)
Secondary	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.	Month 6 (M6)