Study in Cognitively Intact Seniors Aiming to Assess the Effects of Meditation Training
- Conditions
- Cognitive Aging
- Interventions
- Other: Meditation practiceOther: Learning English as a foreign language
- Registration Number
- NCT02977819
- Lead Sponsor
- Institut National de la Santé Et de la Recherche Médicale, France
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 137
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Meditation program Meditation practice Meditation courses and at-home practice English learning courses Learning English as a foreign language English learning courses and at-home practice
- Primary Outcome Measures
Name Time Method 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 Visit 1 inclusion - Visit 3 Month 18 change in anterior cingulate cortex perfusion (early PET-Amyvid® scan)
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 Visit 1 inclusion - Visit 3 Month 18 change in insula perfusion (early PET-Amyvid® scan)
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 Visit 1 inclusion - Visit 3 Month 18 change in anterior cingulate cortex volume (T1-weighted MRI)
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 Visit 1 inclusion - Visit 3 Month 18 change in insula volume (T1-weighted MRI)
- Secondary Outcome Measures
Name Time Method Composite score per cognitive area assessed by the neuropsychological tests and the questionnaires up to 35 months post intervention composite scores will be computed as z-scores calculated from all the cognitive scores obtained for the corresponding cognitive function that will have a normal distribution and will not have a floor or ceiling effect. Additional exploratory analyses will be conducted on all individual behavioural measures obtained.
Medical neuroimaging using MRI: fractional anisotropy and mean diffusivity in all brain voxels up to 35 months post intervention fractional anisotropy and mean diffusivity in all brain voxels
Medical neuroimaging using MRI: hippocampal and hippocampal subfield volumes up to 35 months post intervention hippocampal and hippocampal subfield volumes
Medical neuroimaging using MRI: brain perfusion in all brain voxels up to 35 months post intervention brain perfusion in all brain voxels
Medical neuroimaging using MRI: brain functional connectivity measures in all brain voxels at rest in a non-meditative state up to 35 months post intervention brain functional connectivity measures in all brain voxels at rest in a non-meditative state
Mean duration of sleep up to 35 months post intervention Data collected by actimetrics record
Comparison between meditation intervention and language learning intervention on the global metacognitive composite score up to 35 months post intervention consisting in the mean of the attentional, constructive and deconstructive subscores (main behavioural outcome) Each composite score is computed by averaging its respective standardised scale scores (range (-3) - (4) , Higher score of the meditation composite score mean better outcome)
Medical neuroimaging using MRI: number, size, type and location of white matter lesions up to 35 months post intervention number, size, type and location of white matter lesions
Medical neuroimaging using PET-scan and Amyvid® radiotracer up to 35 months post intervention Brain amyloid load (of the PET-Amyvid® radiotracer) measured in global grey matter mask
Mean z-score of sleep onset latency up to 35 months post intervention Data collected during polysomnographic sleep record with Somno-Art device
Telomerase properties by blood tests visit 1 baseline -Visit 3 18 months Telomerasic activity, telomerase length
lymphocytic immunophenotyping visit 1 baseline -Visit 3 18 months biological blood tests
Difference in partner perceptions of participant depression measured by the Geriatric Depression Scale (range 0-15, higher scores indicate greater depressive symptoms) up to 35 months post intervention Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
Medical neuroimaging using MRI: grey and white matter volume in all brain voxels up to 35 months post intervention grey and white matter volume in all brain voxels
Medical neuroimaging using MRI: magnetic susceptibility index in all brain voxels up to 35 months post intervention magnetic susceptibility index in all brain voxels
Beta-amyloid charge (of the radiopharmarceutical Amyvid®) measured in each voxel of the brain and gross mean in gray matter up to 35 months post intervention measured in each voxel of the brain and gross mean in gray matter
Medical neuroimaging using fMRI: Brain activity specifically associated with attentional processes (altertness, inhibition, sustained attention) during the AX-CPT task. up to 35 months post intervention Brain activity specifically associated with attentional processes (altertness, inhibition, sustained attention) during the AX-CPT task.
Subjectives sleep measures with sleep quality index z-score mean of the scores at questionnaires up to 35 months post intervention Epworth scale, Leeds Sleep evaluation questionnaire, Pittsburg Sleep Quality Scale, St Mary's hospital questionnaire, Berlin Questionnaire, and Insomnia severity index.
Mean z-score of sleep efficiency up to 35 months post intervention Data collected during polysomnographic sleep record with Somno-Art device
Biological blood tests up to 35 months post intervention tau, phosphotau, Ab 40, 42, APOE4, NFL, BDNF, GWAS, cytokines, CRP, cortisol, serotonine, SDHEA, SHBG, E2, testosterone, glycemie, insuline, BNP, tPA, PAI-1, peroxyredoxine
Difference in partner perceptions of participant compassion towards others measured by Compassionate Love Scale (Range 21-147, higher scores indicate greater compassion) up to 35 months post intervention Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
Difference in partner perceptions of participant prosocialness measured by Prosocialness scale (range 16-80, higher scores indicate greater prosocialness) up to 35 months post intervention Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
Glucose Cerebral Consumption at rest (relative to mean consumption measured in the cerebellum) up to 35 months post intervention Glucose Cerebral Consumption at rest (relative to mean consumption measured in the cerebellum) by TEP
Medical neuroimaging using fMRI: Brain activity specifically associated with emotional processes (comparing emotional to neutral items) during the Rest-SoVT task. up to 35 months post intervention Brain activity specifically associated with emotional processes (comparing emotional to neutral items) during the Rest-SoVT task.
fragmentation indices during activity and resting states up to 35 months post intervention Data collected by actimetrics record
Difference in partner perceptions of participant mindfulness measured by Five-Facet Mindfulness Questionnaire (FFMQ-15, range 15-75, higher scores indicate greater mindfulness) up to 35 months post intervention Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant.
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) up to 35 months post intervention Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
regularity of the rest-activity cycle up to 35 months post intervention Data collected by actimetrics record
Mean z-score of total sleep time up to 35 months post intervention Data collected during polysomnographic sleep record with Somno-Art device
Scores to evaluate the impact on volunteers' relatives up to 35 months post intervention scores to hetero questionnaires fulfilled by relatives and qualitative data from interviews with the participants on one hand and with the teachers on the other hand
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) up to 35 months post intervention only for meditation experts
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) up to 35 months post intervention Partners are defined as spouse, sibling, child, neighbour or friend in close contact with the participant
Safety and acceptance up to 35 months post intervention recording adverse events, measurement of anxiety, depression, satisfaction, and well-being using questionnaires
evaluation of the practice of the meditation practice and language learning at long-term (29 months post-intervention) up to 35 months post intervention (because V4 = 29 months post intervention with a window of 6 months questionnaire about the practice (meditation or foreign language)
Behavioral measures (questionnaires) to evaluate the psychological impact of the confinement up to 35 months post intervention composite score per function (anxiety, stress, auto-compassion...)
Trial Locations
- Locations (1)
GIP Cyceron
🇫🇷Caen, Calvados, France