Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
25931/26960
Study information
Scientific title
A randomised controlled trial using MRI scans and cognitive testing to determine the effect of meditation on brain structure and cognition
Acronym
Study hypothesis
We will examine whether there is a causal relationship between meditation practice and the brain anatomy as well as number of physiological and cognitive parameters.
We are testing multiple hypotheses of training novices for 6 weeks, however our main hypotheses are:
1. Signifigant pre-frontal (IFG) and insular cortex density increase for meditation group (MG) measured by MRI.
2. Significant decrease in default mode network connectivity, correlated with increased insular density and improved self-regulation (stop accuracy) and error awareness
3. Signifigantly increased emotional stroop effect, with greater insula response to emotional distractors yet increased stroop accuracy
Ethics approval
The Local Ethics Committee on clinical research approved on the 23rd of August 2010 (ref: 25931/26960)
Study design
Single centre randomised wait list controlled parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Meditation practice
Intervention
1. We studied normal subjects with no prior meditation, or related training undergoing intensive meditation training based on a set of breathing exercises and mindfulness techniques
2. We included 60 university students of which 30 randomly chosen subjects will practice daily 20 minutes for 6 weeks
3. The other 30 subjects (will be the waitlist for meditation training) will act as a control group to check for i.e. training effects in the cognitive tests by being a reading group with same frequency of training and focusing on the narrative content only
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Pre-frontal (IFG) and insular cortex density measured by MRI at baseline and 6 weeks
Secondary outcome measures
Measured at baseline and 6 weeks:
1. Default-mode network connectivity
2. Stop accuracy and error awareness
3. Emotional stroop
Overall trial start date
03/12/2010
Overall trial end date
01/03/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Either sex, aged 18-40 years, ethnic Danes
2. Right handed
3. Health subjects with no history of neurological disorders, psychological and/or psychiatric, cardiovascular or respiratory diseases, brain injury, cancer, addiction to drugs/alcohol, severe impediment to limb movement, hearing and vision
4. Normal MRI brain scan
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Frequent diving, high altitude climbing or flying or other activities related to the respiratory system
2. Recent biofeedback training, hypnosis and acupuncture (due to the possible modulating of the vagal output)
Recruitment start date
03/12/2010
Recruitment end date
01/03/2011
Locations
Countries of recruitment
Denmark
Trial participating centre
Center for Functionally Integrative Neuroscience
Aarhus
8000
Denmark
Funders
Funder type
Government
Funder name
Ministry of Health (Denmark)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list