Mindfulness-based Intervention for People With Parkinsonian Tremor

NCT05168046 | Completed

• 1 other identifier: RECHMPL20_0321
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Conditions

Parkinson Disease; Rest Tremor

Keywords

parkinson disease; rest tremor; mindfulness based intervention; sensors; embrassment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• duration of tremor assessed by agenda

  Day 0 (inclusion), Month 3 (M3)

• duration of tremor assessed by sensors monitoring

  Day 0 (inclusion), Month 3 (M3)

• feasability of the study : number of patients enrolled

  Month 6 (M6)

• feasability of the study : number of patients ended the study

  Month 6 (M6)

• feasability of the study : hours of recording of the tremor

  Month 6 (M6)

Study Arms (2)

Parkinson Mindfullness Based Stress Reduction

EXPERIMENTAL

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

Behavioral: Mindfulness based stress reduction

Parkinson controls

NO INTERVENTION

Patients who have an assessment before and after 6 monthswithout intervention

Interventions

Mindfulness based stress reduction BEHAVIORAL

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

Parkinson Mindfullness Based Stress Reduction

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Institut National de Recherche en Informatique et en Automatique: collaborator
• Université Montpellier: collaborator

Study Sites (1)

Montpellier University Hospital

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Parkinson Disease; Tremor

Interventions

Mindfulness-Based Stress Reduction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2021
• First Posted: December 23, 2021
• Study Start: November 15, 2021
• Primary Completion: October 20, 2024
• Study Completion: October 20, 2024
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)