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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03117478
Other study ID # 69HCL16_0678
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 19, 2016
Est. completion date October 16, 2019

Study information

Verified date June 2021
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The main aim of this project is to explore the neuro-anatomical and -physiological correlates of meditation on attention and emotion-regulation. By investigating this, our scientific goal is to more generally identify the mechanisms and biomarkers of health and mental well-being. Therefore, the investigators use non-invasive imaging like Magneto-EncephaloGraphy (MEG), ElectroEncephaloGraphy (EEG), functional and anatomic Magnetic Resonance Imaging (MRI; including Diffusion tensor - DTI). These brain measures will then be linked to behavioral measurements. Experimental methods (i.e., simple computer tasks) will be used to measure attention, conscious perception and regulation of pain and emotion.


Recruitment information / eligibility

Status Completed
Enrollment 169
Est. completion date October 16, 2019
Est. primary completion date October 16, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 70 Years
Eligibility Inclusion Criteria: - Age : 25-70 - Being affiliated to a social security system. - Motivated to participate in this study. Exclusion Criteria: - Medication acting on the central nervous system - Opioids, Antidepressive Agents. - Actual or previous neurological or psychiatric illnesses - Chronic pain or any other medical condition which is related to pain or an increased sensitivity to pain. - Not having a personal or family history of epilepsy - Alcohol or drugs consumption 2 days before or during the study.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Magneto-encephalography (MEG)
Magneto-encephalography
Electro-encephalography (EEG)
Electro-encephalography
Functional Magnetic Resonance Imaging (fMRI)
Functional Magnetic Resonance Imaging
Anatomical Magnetic Resonance Imaging (aMRI)
Anatomical Magnetic Resonance Imaging
Meditation
Meditation

Locations

Country Name City State
France Le Vinatier Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Anatomical MRI scan Brain structure Day 1
Primary Functional MRI scan Brain activation: Haemodynamic response - BOLD signal. Day1
Primary EEG Event-related potential fields : amplitude in fT and latency in ms. Oscillations : power spectral density and time-frequency oscillations in fT^2/Hz Day 1
Secondary Behavioral measure : Accuracy of the performed task actions Participants will perform behavioral computer tasks in which accuracy and speed is important. Performance behavior will be measured in this task: Accuracy of the performed task actions: number of errors and hits Day 1
Secondary Psychophysics: Pain threshold Pain threshold: The threshold of pain or pain threshold is the point along a curve of increasing perception of a stimulus at which pain begins to be felt. The temperature in degrees Celcius at which heat becomes painful for a recipient. Day 1
Secondary Psychophysiology : Respiration Respiration rate: breaths/minute Day 1
Secondary Subjective experience of the participant Day 1
Secondary Studies biomarkers of inflammation area of the inflamed site in mm^2, obtained by automatic image processing of a photography Day 1
Secondary Behavioral measure : Speed of the performed task actions Participants will perform behavioral computer tasks in which accuracy and speed is important. Performance behavior will be measured in this task: Speed of the performed task actions: in ms. Day 1
Secondary Psychophysiology : Heart Heart Rate: pulses/minute Day 1
Secondary Psychophysiology : Heart rate variability Heart rate variability (HRV): Using an electrocardiogram, the variation in the beat-to-beat interval; measured in ms. Day 1
Secondary Psychophysiology : Muscles Electromyography (EMG): Recording the electrical activity produced by muscles; measured in mV. Day 1
Secondary Psychophysiology : Eyes Eye gaze position: relative to center of the screen, in imm Day 1
Secondary Psychophysiology : Pupillar response Pupillar response: pupil diameter, in mm. Day 1
Secondary Electrogastrogram Recording the electrical signals that travel through the stomach muscles and control the muscles' contractions (waves/minute) Day 1
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