Condition category
Not Applicable
Date applied
23/11/2010
Date assigned
19/05/2011
Last edited
19/05/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Peter Vestergaard-Poulsen

ORCID ID

Contact details

Center for Functionally Integrative Neuroscience
Aarhus University
Norrebrogade 44
Aarhus
8000
Denmark

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 measures

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

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

Sponsor information

Organisation

Aarhus University (Denmark)

Sponsor details

Center for Functionally Integrative Neuroscience
Norrebrogade 44
Aarhus
8000
Denmark

Sponsor type

University/education

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes