Status:
COMPLETED
The Effects of a Meditation Retreat on Healthy Volunteers and Cancer Patients: an fMRI Study
Lead Sponsor:
Hospital Israelita Albert Einstein
Collaborating Sponsors:
Federal University of São Paulo
Conditions:
Healthy
Cancer
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
The purpose of this study is to evaluate the effects of a Zen meditation retreat (Sesshin) on psychophysiological parameters in healthy volunteers (regular meditators and non-meditators) and in cancer...
Detailed Description
Meditation results in changes in cognition, sensory perception, affect, hormones, and autonomic activity. Until today, there have been very few imaging studies of the neural correlates of meditation. ...
Eligibility Criteria
Inclusion
- Healthy volunteers:
- Men or women
- Left-handed or right-handed, as long as there are left-handed individuals in both groups for comparison
- Ages between 18 and 65
- No history of neurological or psychiatric problems, or use of controlled medication that might interfere with attention
- No symptoms of claustrophobia
- Written informed consent form to participate in the study
- Cancer patients:
- The same criteria that apply to healthy volunteers in addition to a diagnosis of neoplasia confirmed by biopsy
- Volunteers should be undergoing post-therapeutical control, have no cure criteria yet, and not have been submitted to radio- or chemotherapy in the last three months
Exclusion
- Healthy Volunteers:
- Chemical dependence, including nicotine and alcohol
- Dementia or psychotic condition (established by a questionnaire)
- Depression or use of antidepressants
- Non-controlled severe organic disease that might interfere with the performance of the study, such as neoplasias, cardiopathies, digestive pathologies, diabetes mellitus type I or type II
- Neoplasias in the central nervous system
- Tremor or dystonia in cephalic segment that hinders the performance of the RMf study (tremor equal to or higher than 3 in each corporal segment, according to the UPDRS scale)
- Fulfillment of any criterion of contraindication for the MR exam (for instance, use of pacemaker; intracranial aneurism clip; cochlear implants)
- Presence of odontological devices that might disturb the magnetic field or any sources of variation of the magnetic susceptibility
- Presence of lesion in the encephalic parenchyma in the structural images. Exception is made to discreet punctiform areas in the white matter or a discreet reduction in the encephalic volume.
- Any other conditions the investigator might deem problematic for the inclusion of the volunteer in a trial of this nature will also be considered
- Cancer patients:
- All the healthy volunteers, except for those that fit in the item: "non-controlled severe organic disease that might interfere in the performance of the study, such"
- The use of medication that acts on the central nervous system
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT00878735
Start Date
January 1 2008
Last Update
June 9 2014
Active Locations (1)
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1
Instituto Israelita de Ensino e Pesquisa Albert Einstein
São Paulo, São Paulo, Brazil, 05652901