Mindfulness-based Intervention for People with Parkinsonian Tremor

Last updated: January 13, 2025
Sponsor: University Hospital, Montpellier
Overall Status: Completed

Phase

N/A

Condition

Dystonia

Treatment

Mindfulness based stress reduction

Clinical Study ID

NCT05168046
RECHMPL20_0321 UF 7999
  • Ages 35-85
  • All Genders

Study 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

Eligibility Criteria

Inclusion

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) andlasting 2 to 6 hours per day

  • patients with internet access

Exclusion

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 (oculomotorimpairment, 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 thestudy

  • refusal to sign informed consent

  • Pregnant or breastfeeding woman

  • Lack of social coverage.

Study Design

Total Participants: 21
Treatment Group(s): 1
Primary Treatment: Mindfulness based stress reduction
Phase:
Study Start date:
November 15, 2021
Estimated Completion Date:
October 20, 2024

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

Connect with a study center

  • Montpellier University Hospital

    Montpellier, 34295
    France

    Site Not Available

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