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Clinical Trials/NCT02977819
NCT02977819
Completed
N/A

Interventional Study in Cognitively Intact Seniors Aiming to Assess the Effects of Meditation Training and Foreign Language Learning on Behavioral, Biological and Neuroimaging Measures

Institut National de la Santé Et de la Recherche Médicale, France1 site in 1 country137 target enrollmentNovember 24, 2016
ConditionsCognitive Aging

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cognitive Aging
Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Enrollment
137
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 24, 2016
End Date
December 9, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institut National de la Santé Et de la Recherche Médicale, France
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: Visit 1 inclusion - Visit 3 Month 18

change in insula volume (T1-weighted MRI)

Secondary Outcomes

  • Composite score per cognitive area assessed by the neuropsychological tests and the questionnaires(up to 35 months post intervention)
  • Medical neuroimaging using MRI: fractional anisotropy and mean diffusivity in all brain voxels(up to 35 months post intervention)
  • Medical neuroimaging using MRI: hippocampal and hippocampal subfield volumes(up to 35 months post intervention)
  • Medical neuroimaging using MRI: brain perfusion in all brain voxels(up to 35 months post intervention)
  • 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)
  • Mean duration of sleep(up to 35 months post intervention)
  • Comparison between meditation intervention and language learning intervention on the global metacognitive composite score(up to 35 months post intervention)
  • Medical neuroimaging using MRI: number, size, type and location of white matter lesions(up to 35 months post intervention)
  • 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)
  • Medical neuroimaging using PET-scan and Amyvid® radiotracer(up to 35 months post intervention)
  • Mean z-score of sleep onset latency(up to 35 months post intervention)
  • Telomerase properties by blood tests(visit 1 baseline -Visit 3 18 months)
  • lymphocytic immunophenotyping(visit 1 baseline -Visit 3 18 months)
  • 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)
  • 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)
  • Medical neuroimaging using MRI: grey and white matter volume in all brain voxels(up to 35 months post intervention)
  • Medical neuroimaging using MRI: magnetic susceptibility index in all brain voxels(up to 35 months post intervention)
  • Subjectives sleep measures with sleep quality index z-score mean of the scores at questionnaires(up to 35 months post intervention)
  • Mean z-score of sleep efficiency(up to 35 months post intervention)
  • Biological blood tests(up to 35 months post intervention)
  • 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)
  • 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)
  • Glucose Cerebral Consumption at rest (relative to mean consumption measured in the cerebellum)(up to 35 months post intervention)
  • 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)
  • fragmentation indices during activity and resting states(up to 35 months post intervention)
  • 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)
  • 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)
  • regularity of the rest-activity cycle(up to 35 months post intervention)
  • Mean z-score of total sleep time(up to 35 months post intervention)
  • Scores to evaluate the impact on volunteers' relatives(up to 35 months post intervention)
  • 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)
  • 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)
  • Safety and acceptance(up to 35 months post intervention)
  • 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)
  • Behavioral measures (questionnaires) to evaluate the psychological impact of the confinement(up to 35 months post intervention)

Study Sites (1)

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