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| Tracking Information | |
|---|---|
| First Received Date ICMJE | January 29, 2002 |
| Last Updated Date | August 17, 2006 |
| Start Date ICMJE | September 2000 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00029978 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Transfer of Neural Energy Between Humans |
| Official Title ICMJE | Transfer of Neural Energy Between Human Subjects |
| Brief Summary | The purpose of this study is to determine whether visual evoked potentials generated in one human brain by photostimulation can generate a correlated EEG signal in the brain of another human subject who is located at a distance and who is not visually stimulated. |
| Detailed Description | This study will attempt to replicate findings suggesting that visual evoked potentials generated in one human brain (Subject A) by photostimulation can generate a correlated EEG signal in the brain of another human subject (subject B) who is located at a distance (14.5 meters) and who is not visually stimulated. This project will occur in three stages. First we will identify pairs of subjects who have cross-correlated evoked potentials during photostimulation to Subject A at the p < .01 level of significance. If no pairs can be identified we will continue to enroll and test up to 50 pairs of subjects. If pairs of subjects that demonstrate the phenomenon cannot be identified using this p value by the end of the project time line we will reject the hypothesis that remote transfer of neural energy occurs and report failure to replicate the original study. If we detect greater than or equal to 5 pairs of subjects who meet the criteria we will attempt to replicate in those pairs using a higher criteria of p < .001. If Grinberg-Zylberbaum et al's experiment can be replicated at both stages, the project team will go to stage 3 to investigate the same phenomenon in the identified pairs of human subjects using functional magnetic resonance imaging (fMRI) as a second independent neurophysiological measure of transfer of information between two human brains. We will record fMRIs (occipital, temporal, frontal and parietal) in the remote individual while their counterpart, located in a separate chamber, is receiving light stimulation in an on-off pattern. We will determine if there are statistically significant differences in digitized fMRI during lights on vs. lights off conditions. The main outcome measures for this project will be the binary (yes-no) output from statistical analysis using cross-correlational and z-score testing for the detection of a transferred evoked signal (in both EEG and fMRI experiments) in Subject B. Appropriate controls will be used. If replicated, this study will provide a useful technology and method to quantitatively investigate the characteristics and neural mechanisms of remote effects of "mental events." Such experimental methods will assist in the investigation of basic mechanisms involved in "mind-body" medicine. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | Cross-Sectional, Defined Population |
| Condition ICMJE | Healthy |
| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 60 |
| Completion Date | January 2004 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria
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| Gender | Both |
| Ages | 18 Years to 65 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00029978 |
| Responsible Party | |
| Study ID Numbers ICMJE | R21 AT000287-01 |
| Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) |
| Verification Date | July 2006 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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