Mindfulness-based Intervention for People With Parkinsonian Tremor (MEDITAPARK)

University Hospital Center (CHU)

Status: Completed

Conditions: Rest Tremor; Parkinson Disease

Treatments: Behavioral: Mindfulness based stress reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT05168046

RECHMPL20_0321

Details and patient eligibility

About

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

Full 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

Enrollment: 21 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Parkinson Mindfullness Based Stress Reduction

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness based stress reduction

Parkinson controls

No Intervention group

Description:

Patients who have an assessment before and after 6 monthswithout intervention