HealthyNCT00029978
Transfer of Neural Energy Between Humans
An observational study of Healthy, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Jan 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pairs of healthy human volunteers 18-65 years of age who know each other and who each answered "yes" to the following statement: "I have had at least one experience of feeling the presence of a friend/relative/partner even when we are not physically together."
- Subjects have at least one year experience practicing meditation, relaxation techniques, contemplation or prayer at least once a week.
- Willingness to report to the University of Washington on at least 1-2 occasions and up to a maximum of 6 visits, for 1-2 hour sessions each visit.
- Willingness to undergo FreezeFrame relaxation training in a 8 minute session.
- Willingness to have EEG and EKG measurements.
- Willingness to undergo functional MRI evaluation for 45-60 minutes in a small horizontal chamber and to be exposed to high decibel auditory stimulation during the procedure (optional).
- Ability to provide informed consent.
- Visual acuity 20/20 or better in each eye, with correction.
Who cannot join
- Diagnosis of neurological disease, including epilepsy. History of epilepsy.
- Diagnosis of psychiatric disorder either past or current.
- Visual acuity more than 25/25 in each eye, with correction.
- Implanted devices or metal objects such as pacemakers, aneurysm clips, metal bone or joint pins, or shrapnel (in case of willingness to participate in fMRI part of the study).
- Current use of psychotropic medications, either prescription or illicit.
- History of self-reported claustrophobia (in case of willingness to participate in fMRI part of the study).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transfer of Neural Energy Between Human Subjects
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.
Read the 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.
- Conditions
- Healthy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2002 (estimated)
- Study startSep 2000
- Study completionJan 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00029978
- Sponsor's protocol ID
- R21AT000287-01
- Status last verified
- Jul 2006
- First submitted
- 29 Jan 2002
- Last updated
- 18 Aug 2006
- Results posted
- No
Publications
Standish LJ, Johnson LC, Kozak L, Richards T. Evidence of correlated functional magnetic resonance imaging signals between distant human brains. Altern Ther Health Med. 2003 Jan-Feb;9(1):128, 122-5. No abstract available.
PubMed 14640097Standish LJ, Kozak L, Johnson LC, Richards T. Electroencephalographic evidence of correlated event-related signals between the brains of spatially and sensory isolated human subjects. J Altern Complement Med. 2004 Apr;10(2):307-14. doi: 10.1089/107555304323062293.
PubMed 15165411
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transfer of Neural Energy Between Human Subjects
- ClinicalTrials.gov ID
- NCT00029978
- Acronym / sponsor ID
- R21AT000287-01
- Conditions
- Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Center for Complementary and Integrative Health (NCCIH)US National Institutes of Health
- Study start
- Sep 2000
- Study completion
- Jan 2004
- First posted
- 30 Jan 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Defined population
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Pairs of healthy human volunteers 18-65 years of age who know each other and who each answered "yes" to the following statement: "I have had at least one experience of feeling the presence of a friend/relative/partner even when we are not physically together."
- Subjects have at least one year experience practicing meditation, relaxation techniques, contemplation or prayer at least once a week.
- Willingness to report to the University of Washington on at least 1-2 occasions and up to a maximum of 6 visits, for 1-2 hour sessions each visit.
- Willingness to undergo FreezeFrame relaxation training in a 8 minute session.
- Willingness to have EEG and EKG measurements.
Key exclusion criteria (6 listed)
- Diagnosis of neurological disease, including epilepsy. History of epilepsy.
- Diagnosis of psychiatric disorder either past or current.
- Visual acuity more than 25/25 in each eye, with correction.
- Implanted devices or metal objects such as pacemakers, aneurysm clips, metal bone or joint pins, or shrapnel (in case of willingness to participate in fMRI part of the study).
- Current use of psychotropic medications, either prescription or illicit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2006.
- Background: PubMed 14640097Standish LJ, Johnson LC, Kozak L, Richards T. Evidence of correlated functional magnetic resonance imaging signals between distant human brains. Altern Ther Health Med. 2003 Jan-Feb;9(1):128, 122-5. No abstract available.
- Background: PubMed 15165411Standish LJ, Kozak L, Johnson LC, Richards T. Electroencephalographic evidence of correlated event-related signals between the brains of spatially and sensory isolated human subjects. J Altern Complement Med. 2004 Apr;10(2):307-14. doi: 10.1089/107555304323062293.
- Recruitment InformationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by National Center for Complementary and Integrative Health (NCCIH) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Aug 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00029978, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2006.