Mindfulness-based Intervention for People With Parkinsonian Tremor

NCT ID: NCT05168046

Last Updated: 2025-09-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-15
• Study Completion Date: 2024-10-20

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

Conditions

Parkinson Disease; Rest Tremor

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Parkinson Mindfullness Based Stress Reduction

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

Group Type: EXPERIMENTAL

Mindfulness based stress reduction

Intervention Type: BEHAVIORAL

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

Parkinson controls

Patients who have an assessment before and after 6 monthswithout intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness based stress reduction

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de Recherche en Informatique et en Automatique

OTHER

Sponsor Role: collaborator

Université Montpellier

OTHER

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Montpellier University Hospital

Montpellier, , France

Countries

France

Other Identifiers

RECHMPL20_0321

Identifier Type: -

Identifier Source: org_study_id