Clinical trial NCT02977819: Study in Cognitively Intact Seniors Aiming to Assess the Effects of Meditation Training
Official title: Interventional Study in Cognitively Intact Seniors Aiming to Assess the Effects of Meditation Training and Foreign Language Learning on Behavioral, Biological and Neuroimaging Measures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Aging
Lead sponsor: Institut National de la Santé Et de la Recherche Médicale, France
Sponsor class: OTHER_GOV
First posted: 2016-11-30
Enrollment: 137
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: As the number of older people in Europe grows, increasing healthy life years is a priority. As people live longer, ensuring good mental as well as physical health into later years is becoming ever more important. Cognitive decline, dementia (e.g. Alzheimer's Disease, AD), sleep disturbances and depression, all related to psychological distress and anxiety, are significant drivers of reduced quality of life in older adults. This project builds on evidence that meditation practice have the potential to downregulate these adverse factors and positively impact mental and neurological conditions including AD.

Detailed description: Understanding of the neurocognitive mechanisms of meditation is still limited. Meditation can be conceptualized as "a set of complex emotional and attentional regulation strategies developed for a variety of purposes including the development of emotional well-being and balance". Affective (emotional) and cognitive (attentional) control are therefore the most likely mechanisms by which meditation could impact aging and AD. Specifically, meditation could enhance the controlling role of mid-brain structures and the executive network over structures involved in memory, emotions, and regulation of the immune system. This would lead to better emotional and cognitive control which in turn would be associated with improved mental and physical health.

Eligibility criteria: 1. Inclusion Criteria :

   For all participants
   * Age ≥ 65 years ;
   * To be autonomous
   * Live in their home;
   * Educational level ≥ 7 years (from the Preparatory Course (First grade) included);
   * To be registered to the social security system ;
   * To be motivated to effectively participate in the project and to sign the consent form in agreement with the local ethic committee ;
   * Neuropsychological performances within the normal range (according to age, sex, and educational level), as assessed by the diagnostic battery.

   For participants without previous meditation practice
   * French mother tongue;
   * Available for the trial duration (24 months);
   * Retired since 1 year or more;
   * No preference regarding the intervention group ;
   * Not having regularly or intensively practiced meditation or comparable practices (yoga, Qi Gong, Alexander technique) as follows :

     * more than one day per week for more than six months consecutively over the last 10 years,
     * intensively (internship or retreat \> five consecutive days) over the past 10 years,
     * more than 25 days of retreats (cumulatively) prior to the last 10 years ;
   * Not speaking English fluently.

   For expert meditators :
   * Formal meditation practice \> 10 000 hours in the whole life, including at least 6 cumulated months of retreat;
   * Daily meditation practice (at least 6 days/week, 45 minutes/day);
   * Mindfulness meditation practice (i.e. mindfulness, samatha/vipassana, zazen (zen), shikantaza (zen), focused attention, mahamudra/Dzogchen, and compassion/loving jindness (tonglen, metta/karuna, bodhichitta)
2. Exclusion criteria :

   * Contraindication to MRI or PET Amyvid® ;
   * For security reasons realted with the use of Amyvid®, a blood sampling allowing to measure hepatic and renal functions will be performed at the V1 visit before the PET-Amyvid® scan. In case anomalies are detected of grade 3 or higher severity, the PET-Amyvid® scan will not be performed.
   * Hypersensitivity to Amyvid®
   * History or presence of a major neurological or psychiatric disorder (including an addiction to alcohol or drugs);
   * History of cerebral disease (vascular, degenerative, physical malformation, tumor, or head trauma with loss of consciousness for more than an hour);
   * Presence of a chronic disease or acute unstable illness (respiratory, cardiovascular, digestive, renal, metabolic, hematologic, endocrine or infectious);
   * Current or recent medication that may interfere with cognitive action or radiological measures (psychotropic drugs, antihistamines, anti-Parkinsonian drugs, benzodiazepines, non-steroidal anti-inflammatory agents, antiepileptics, central analgesic and muscle relaxants);
   * Under legal guardianship or incapacitation;
   * Inclusion in another biomedical research protocol at baseline, if including use of a radiolabel for radiological measures;
   * Physical of behavioural inhabilities to perform the follow-up visits as planned in the study protocol.

Primary outcomes:
measure: Estimate the effect of an 18-month meditation intervention in non-meditating senior participants on the volume of the anterior cingulate cortex compared to a passive control intervention
timeFrame: Visit 1 inclusion - Visit 3 Month 18
measure: Estimate the effect of an 18-month meditation intervention in non-meditating senior participants on the perfusion of the anterior cingulate cortex compared to a passive control intervention
timeFrame: Visit 1 inclusion - Visit 3 Month 18
measure: Estimate the effect of an 18-month meditation intervention in non-meditating seniors on the volume of the insula compared to an 18 months intervention of learning a foreign language
timeFrame: Visit 1 inclusion - Visit 3 Month 18
measure: Estimate the effect of an 18-month meditation intervention in non-meditating seniors on the perfusion of the insula compared to an 18 months intervention of learning a foreign language
timeFrame: Visit 1 inclusion - Visit 3 Month 18
Secondary outcomes:
measure: Comparison between meditation intervention and language learning intervention on the global metacognitive composite score
timeFrame: up to 35 months post intervention
measure: Composite score per cognitive area assessed by the neuropsychological tests and the questionnaires
timeFrame: up to 35 months post intervention
measure: Medical neuroimaging using MRI: grey and white matter volume in all brain voxels
timeFrame: up to 35 months post intervention
measure: Medical neuroimaging using MRI: hippocampal and hippocampal subfield volumes
timeFrame: up to 35 months post intervention
measure: Medical neuroimaging using MRI: brain perfusion in all brain voxels
timeFrame: up to 35 months post intervention
measure: Medical neuroimaging using MRI: fractional anisotropy and mean diffusivity in all brain voxels
timeFrame: up to 35 months post intervention
measure: Medical neuroimaging using MRI: number, size, type and location of white matter lesions
timeFrame: up to 35 months post intervention
measure: Medical neuroimaging using MRI: magnetic susceptibility index in all brain voxels
timeFrame: up to 35 months post intervention
measure: Medical neuroimaging using MRI: brain functional connectivity measures in all brain voxels at rest in a non-meditative state
timeFrame: up to 35 months post intervention
measure: Beta-amyloid charge (of the radiopharmarceutical Amyvid®) measured in each voxel of the brain and gross mean in gray matter
timeFrame: up to 35 months post intervention
measure: Glucose Cerebral Consumption at rest (relative to mean consumption measured in the cerebellum)
timeFrame: up to 35 months post intervention
measure: Medical neuroimaging using fMRI: Brain activity specifically associated with emotional processes (comparing emotional to neutral items) during the Rest-SoVT task.
timeFrame: up to 35 months post intervention
measure: Medical neuroimaging using fMRI: Brain activity specifically associated with attentional processes (altertness, inhibition, sustained attention) during the AX-CPT task.
timeFrame: up to 35 months post intervention
measure: Medical neuroimaging using PET-scan and Amyvid® radiotracer
timeFrame: up to 35 months post intervention
measure: Subjectives sleep measures with sleep quality index z-score mean of the scores at questionnaires
timeFrame: up to 35 months post intervention
measure: Mean duration of sleep
timeFrame: up to 35 months post intervention
measure: fragmentation indices during activity and resting states
timeFrame: up to 35 months post intervention
measure: regularity of the rest-activity cycle
timeFrame: up to 35 months post intervention
measure: Mean z-score of total sleep time
timeFrame: up to 35 months post intervention
measure: Mean z-score of sleep onset latency
timeFrame: up to 35 months post intervention
measure: Mean z-score of sleep efficiency
timeFrame: up to 35 months post intervention
measure: Biological blood tests
timeFrame: up to 35 months post intervention
measure: Telomerase properties by blood tests
timeFrame: visit 1 baseline -Visit 3 18 months
measure: lymphocytic immunophenotyping
timeFrame: visit 1 baseline -Visit 3 18 months
measure: Difference in partner perceptions of participant mindfulness measured by Five-Facet Mindfulness Questionnaire (FFMQ-15, range 15-75, higher scores indicate greater mindfulness)
timeFrame: up to 35 months post intervention
measure: Difference in partner perceptions of participant compassion towards others measured by Compassionate Love Scale (Range 21-147, higher scores indicate greater compassion)
timeFrame: up to 35 months post intervention
measure: Difference in partner perceptions of participant depression measured by the Geriatric Depression Scale (range 0-15, higher scores indicate greater depressive symptoms)
timeFrame: up to 35 months post intervention
measure: Scores to evaluate the impact on volunteers' relatives
timeFrame: up to 35 months post intervention
measure: Difference in partner perceptions of participant anxiety measured by trait subscale of the state-trait anxiety inventory (trait-STAI, range 20-80, higher scores indicate greater anxiety symptoms)
timeFrame: up to 35 months post intervention
measure: Difference in partner perceptions of participant prosocialness measured by Prosocialness scale (range 16-80, higher scores indicate greater prosocialness)
timeFrame: up to 35 months post intervention
measure: Difference in partner perceptions of participant's cognitive difficulties in everyday life, measured by Mc Nair CDS (range 0-156, higher score indicates greater cognitive difficulties)
timeFrame: up to 35 months post intervention
measure: Neural signature of meditative practices using brain medical imaging (neuronal activity in each cerebral voxel (fMRI) at rest and during the emotional task, in a mindfulness meditative state versus not; in compasional meditative state or not)
timeFrame: up to 35 months post intervention
measure: Safety and acceptance
timeFrame: up to 35 months post intervention
measure: evaluation of the practice of the meditation practice and language learning at long-term (29 months post-intervention)
timeFrame: up to 35 months post intervention (because V4 = 29 months post intervention with a window of 6 months
measure: Behavioral measures (questionnaires) to evaluate the psychological impact of the confinement
timeFrame: up to 35 months post intervention
Other outcomes:
Locations:
city: Caen
country: France
facility: GIP Cyceron
state: Calvados
Study officials:
affiliation: CHU Caen - France
name: De La Sayette Vincent
role: PRINCIPAL_INVESTIGATOR
affiliation: GIP Cyceron Caen
name: Chételat Gaël
role: STUDY_DIRECTOR
References:
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