Parkinson DiseaseMEDITAPARKNCT05168046
Mindfulness-based Intervention for People With Parkinsonian Tremor
A study testing Mindfulness based stress reduction in people with Parkinson Disease and Rest Tremor, run by University Hospital, Montpellier at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Parkinson Disease, Rest Tremor
- What is being tested?
- Mindfulness based stress reduction
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2021to 20 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study of the Ambulatory Monitoring Evaluation of a Mindfulness Meditation Programme in Parkinsonian Tremor
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
Read the 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
- Being tested
- Mindfulness based stress reduction
- Keywords
- parkinson disease, rest tremor, mindfulness based intervention, sensors, embrassment
- Medical subject headings
- Parkinson Disease, Tremor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness based stress reductionBehavioural
program of weekly mindfulness based stress reduction intervention during 2 months and practice during 3 months
| Study group | Role | What they receive |
|---|---|---|
| Parkinson Mindfullness Based Stress Reduction | Experimental | Patients who have an assessment before and after a mindfulness based stress reduction intervention for 6 months Receives: Behavioral: Mindfulness based stress reduction |
| Parkinson controls | No intervention | Patients who have an assessment before and after 6 monthswithout intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Month 6 (M6)
Secondary outcomes (10)
duration of tremor assessed by agenda
Weekly cumulative time differences of tremor periods on Hauser's modified auto-diary (2000)
Measured: Day 0 (inclusion), Month 3 (M3)
duration of tremor assessed by sensors monitoring
Weekly cumulative time differences of tremor periods recorded with the connected watch
Measured: Day 0 (inclusion), Month 3 (M3)
feasability of the study : number of patients enrolled
- Proportion of patients included among screened patients
Measured: Month 6 (M6)
feasability of the study : number of patients ended the study
- Proportion of patients who completed the meditation program
Measured: Month 6 (M6)
feasability of the study : hours of recording of the tremor
- Proportion of hours of recording of the tremor compared to the planned duration
Measured: Month 6 (M6)
feasability of the study : tolerance
Tolerance to the meditation program assessed with a 10-point Likert scale
Measured: Month 6 (M6)
feasability of the study : COREQ 1
- Focus Groups Consolidated Criteria for Reporting on Qualitative Studies (COREQ) 1
Measured: Month 6 (M6)
Severity tremor index assessed by sensors monitoring
Differences in the Severity tremor index (mean amplitude of the tremor measured by the smartwatch)
Measured: Month 3 (M3)
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)
Measured: Month 6 (M6)
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.
Measured: Month 6 (M6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2021
- Study start15 Nov 2021
- Primary completion20 Oct 2024
- Study completion20 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National de Recherche en Informatique et en Automatique, Université Montpellier
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05168046
- Sponsor's protocol ID
- RECHMPL20_0321
- Acronym
- MEDITAPARK
- Status last verified
- Sep 2025
- First submitted
- 29 Oct 2021
- Last updated
- 30 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of the Ambulatory Monitoring Evaluation of a Mindfulness Meditation Programme in Parkinsonian Tremor
- ClinicalTrials.gov ID
- NCT05168046
- Acronym / sponsor ID
- MEDITAPARK / RECHMPL20_0321
- Conditions
- Parkinson Disease, Rest Tremor
- Keywords
- parkinson disease, rest tremor, mindfulness based intervention, sensors, embrassment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Institut National de Recherche en Informatique et en Automatique, Université Montpellier
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 20 Oct 2024 (actual)
- Study completion
- 20 Oct 2024 (actual)
- First posted
- 23 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson Mindfullness Based Stress Reduction | Experimental | Behavioral: Mindfulness based stress reductionPatients who have an assessment before and after a mindfulness based stress reduction intervention for 6 months |
| Parkinson controls | No intervention | –Patients who have an assessment before and after 6 monthswithout intervention |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness based stress reductionprogram of weekly mindfulness based stress reduction intervention during 2 months and practice during 3 months | Behavioural | Parkinson Mindfullness Based Stress Reduction |
Primary outcome
Essential Tremor Embarrassment Assessment score
Time frame: Month 6 (M6)
Essential Tremor Embarassment Assessment scale, ETEA : this scale is a self questionnaire made up of 14 items (0 to 5, 5 = worst embarrassment)
10 secondary outcomes
duration of tremor assessed by agenda
Time frame: Day 0 (inclusion), Month 3 (M3)
duration of tremor assessed by sensors monitoring
Time frame: Day 0 (inclusion), Month 3 (M3)
feasability of the study : number of patients enrolled
Time frame: Month 6 (M6)
feasability of the study : number of patients ended the study
Time frame: Month 6 (M6)
feasability of the study : hours of recording of the tremor
Time frame: Month 6 (M6)
feasability of the study : tolerance
Time frame: Month 6 (M6)
feasability of the study : COREQ 1
Time frame: Month 6 (M6)
Severity tremor index assessed by sensors monitoring
Time frame: Month 3 (M3)
Quality of life : Parkinson Disease Questionnaire 39 (PDQ39) scale
Time frame: Month 6 (M6)
Quality of life : Hamilton anxiety and depression scale (HADS)
Time frame: Month 6 (M6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness based stress reduction in people with Parkinson Disease and Rest Tremor, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Essential Tremor Embarrassment Assessment score (time frame: Month 6 (M6)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.