Neural Correlates of Self

Healthy Volunteers Clinical Trial

— NeuCoSe  

Official title:

The Neural Correlates of the " Self " in Altered States of Consciousness

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03206840
• Other study ID #: 69HCL17_0274
• Secondary ID: 2017-A01923-50
• Status: Completed
• Phase: N/A
• Start date: October 26, 2017
• Est. completion date: November 12, 2018

Study information

• Verified date: March 2019
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Despite the increasing popularity of mindfulness meditation and hypnosis in healthcare and in the general community the underlying neurobiological mechanisms are unclear. The change in the relationship between the self and the conscious experience that they bring about may be crucial. This study aims to identify the neural correlates of self-consciousness in meta-awareness and absorption - using functional Magnetic Resonance Imaging (fMRI) in healthy participants combined with detailed first-person experiential accounts and behavioural tasks. This study will provide important clues about the widely reported effects of mindfulness meditation and hypnosis and shed light on the neural correlates of the conscious experience of self.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 12, 2018
• Est. primary completion date: November 12, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• aged 18-70

• Body mass index between 18.5 and 30

• Covered by health insurance

• motivated to participate

• signed informed consent

• normal or corrected-to-normal eyesight

• sufficient command of French to be able to follow the instructions

Exclusion Criteria:

• history of neurological or psychiatric conditions

• chronic pain or another medical condition altering pain perception

• use of medication that affects the central nervous system

• use of opioids or antidepressant medication

• severe auditory loss

• consumption of alcohol or intoxicants on the day of the experiments and the day preceding the experiments

• pregnancy, breastfeeding or having given birth <6months ago

• any contra-indication to Magnetic Resonance Imaging (metal implants or foreign bodies), agitation, claustrophobia

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Behavioral:
• "control", "meditation", "hypnosis".
three instructions will be given to each participant: "control", "meditation", "hypnosis". The order of "meditation" and "hypnosis" will be randomized amongst two groups to avoid order effects.

Locations

Country	Name	City	State
France	Hospices Civils de Lyon Hôpital le Vinatier/Inserm	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	Reaction time (minutes)	reaction times during behavioural tasks.	at day 1
Primary	Brain activation with IRM	Activation of different brain areas, as measured with functional Magnetic Resonance	At day 3
Secondary	personality trait with questionnaires	scores on different personality questionnaires	at day 2
Secondary	Scores during behavioural tasks	scores on likert scale (1-5 and 1-9) about intensity of the stimui presented during the task	at day 1
Secondary	Scores during behavioural tasks	scores on likert scale (1-5 and 1-9) about intensity of the stimui presented during the task	at day 3
Secondary	salivary volume (millimeter)	salivary volume after behavioural tasks	at day 1