Spatiotemporal PatternsNCT00283907
Brain Networks Responsible for Sense of Agency
An observational study of Spatiotemporal Patterns, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study of healthy normal volunteers will examine the brain networks involved in people's sense that they control their own movements (sense of agency). Although almost everyone has a sense of agency, some patients (for example, patients with schizophrenia, alien limb phenomena, and others) have movements they… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Spatiotemporal Patterns
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jan 2006to 16 Dec 2008
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects age 18 and older
- Subjects must be right-hand dominant (Edinburgh Handedness Quotient greater than 60)
- Subjects willing to abstain from caffeine or alcohol for 48 hours prior to the EEG study
Who cannot join
- Subjects with any abnormal findings on neurological exam
- Subjects with any history of brain tumor, stroke, head trauma or a vascular malformation as obtained by history or from imaging studies
- Subjects with any history of a severe medical condition, such as cardiovascular disease, which would prevent them from sitting for up to 120 minutes
- Subjects without the capacity to give informed consent
- Subjects with other restrictions which prevent them from undergoing EEG recordings for up to 60 minutes
- Subjects who are taking neuroleptic medications
- Subjects are not eligible for Magnetic Resonance Imaging (MRI) scan, if the subjects have pacemakers, intracardiac line, implanted metallic pump, neural stimulator, or a metallic object inside the skull, metal braces, cochlear devices, surgical clips and other metal/magnetic implants; are afraid of being in small spaces; are pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Brain Networks Responsible for Sense of Agency: An EEG Study
This study of healthy normal volunteers will examine the brain networks involved in people's sense that they control their own movements (sense of agency). Although almost everyone has a sense of agency, some patients (for example, patients with schizophrenia, alien limb phenomena, and others) have movements they think are not under their control. This study will use electroencephalography (EEG) to determine how the normal brain produces the sense of agency. This information will provide a first step in understanding patients with an impaired sense of agency.
Healthy, right-handed men and women 18 years of age and older may be eligible for this study. Candidates are screened with a medical history and neurological examination.
Read more
Participants are fitted with a cyberglove device (a lightweight glove with flexible sensors that measure the position and movement of the fingers and wrist) on their right hand. The glove is used to transform the subject's hand and finger motions into real-time digital joint-angle information. Subjects slowly open and close their hand while watching an artificial hand projected on a monitor. They continue practicing the exercise until they are comfortable with the cyberglove and have the sense that the artificial hand is a mirror representation of their own hand, accurately reflecting their hand's movements.
After practicing with the cyberglove, subjects have a functional EEG. For this test, electrodes are placed on the scalp, and brain waves are recorded while the subject opens and closes his or her hand or just watches the computer monitor. The EEG recording takes about 60 minutes.
...
Read the detailed description
Objective
The purpose of this study is to investigate spatiotemporal patterns of brain networks involved in the sense of agency using high-resolution electroencephalography (EEG).
Study Population
We intend to use 20 right-hand dominant, adult healthy subjects.
Design
The sense of agency (SA) will be modulated using a visual task-based stimulus asking subjects to manipulate the position of an artificial hand projected onto a display. Subjects will use their own right hand to make slow opening/closing movements randomly which will be represented visually with the aid of a Cyberglove. During a behavioral training phase, subjects will practice using the apparatus. The level of control will be randomly changed to one of five states: 100%, 75%, 50%, 25%, 0% control. For secondary analysis, subjects will be asked to report the percentage of control they subjectively feel over the displayed hand. After subjects are comfortable with the apparatus and endorse SA over the displayed hand, they will undergo EEG.
The experimental phase will have five sets of 10 minute recording sessions where the subject is instructed to slowly open and close their hand randomly. The level of control will be changed pseudo-randomly throughout the recording sessions. A control contrast consisting of the subject observing a moving hand will also be integrated into the blocks. An additional control contrast involving the subject moving their hand without visual feedback will also be included. These contrasts will serve in the analysis phase to help eliminate electrophysiological activity related to visual-motor feedback.
A Magnetic Resonance Imaging (MRI) scan of brain will be performed to co-register this EEG data with the anatomical structure. We will integrate physiological (EEG) and anatomical (MRI) data to characterize the regionalization of the task-related brain EEG activity.
Outcome Measures
The primary outcome of this study is the effective connectivity of brain in response to a loss of SA. For this purpose, we will measure the difference of EEG power spectral analysis as well as coherence between 0% and 100 % control. In a secondary analysis, we will investigate the correlation of the EEG measurements with the percent of actual control, and also utilize the individual subject perceptions of percent control during the behavioral training phase as the regressors for activation rather than the objective control settings.
- Conditions
- Spatiotemporal Patterns
- Keywords
- Electroencephalogram (EEG), Sense of Agency, Coherence, Voluntary Movement, Self-Agency, Healthy Volunteer, HV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2006 (estimated)
- Study start27 Jan 2006
- Study completion16 Dec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spatiotemporal PatternsStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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
- Enrolment
- 20 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283907
- Sponsor's protocol ID
- 060084
- Other IDs
- 06-N-0084
- Status last verified
- 16 Dec 2008
- First submitted
- 29 Jan 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Gallagher S. Philosophical conceptions of the self: implications for cognitive science. Trends Cogn Sci. 2000 Jan;4(1):14-21. doi: 10.1016/s1364-6613(99)01417-5.
PubMed 10637618Kircher TT, Leube DT. Self-consciousness, self-agency, and schizophrenia. Conscious Cogn. 2003 Dec;12(4):656-69. doi: 10.1016/s1053-8100(03)00071-0.
PubMed 14656508Blakemore SJ, Frith CD, Wolpert DM. The cerebellum is involved in predicting the sensory consequences of action. Neuroreport. 2001 Jul 3;12(9):1879-84. doi: 10.1097/00001756-200107030-00023.
PubMed 11435916
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Networks Responsible for Sense of Agency: An EEG Study
- ClinicalTrials.gov ID
- NCT00283907
- Acronym / sponsor ID
- 060084
- Conditions
- Spatiotemporal Patterns
- Keywords
- Electroencephalogram (EEG), Sense of Agency, Coherence, Voluntary Movement, Self-Agency, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 27 Jan 2006
- Study completion
- 16 Dec 2008
- First posted
- 30 Jan 2006 (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.
This study of healthy normal volunteers will examine the brain networks involved in people's sense that they control their own movements (sense of agency). Although almost everyone has a sense of agency, some patients (for example, patients with schizophrenia, alien limb phenomena, and others) have movements they think are not under their control. This study will use electroencephalography (EEG) to determine how the normal brain produces the sense of agency. This information will provide a first step in understanding patients with an impaired sense of agency.
Healthy, right-handed men and women 18 years of age and older may be eligible for this study. Candidates are screened with a medical history and neurological examination.
Participants are fitted with a cyberglove device (a lightweight glove with flexible sensors that measure the position and movement of the fingers and wrist) on their right hand. The glove is used to transform the subject's hand and finger motions into real-time digital joint-angle information. Subjects slowly open and close their hand while watching an artificial hand projected on a monitor. They continue practicing the exercise until they are comfortable with the cyberglove and have the sense that the artificial hand is a mirror representation of their own hand, accurately reflecting their hand's movements.
After practicing with the cyberglove, subjects have a functional EEG. For this test, electrodes are placed on the scalp, and brain waves are recorded while the subject opens and closes his or her hand or just watches the computer monitor. The EEG recording takes about 60 minutes.
...
Detailed description
Objective
The purpose of this study is to investigate spatiotemporal patterns of brain networks involved in the sense of agency using high-resolution electroencephalography (EEG).
Study Population
We intend to use 20 right-hand dominant, adult healthy subjects.
Design
The sense of agency (SA) will be modulated using a visual task-based stimulus asking subjects to manipulate the position of an artificial hand projected onto a display. Subjects will use their own right hand to make slow opening/closing movements randomly which will be represented visually with the aid of a Cyberglove. During a behavioral training phase, subjects will practice using the apparatus. The level of control will be randomly changed to one of five states: 100%, 75%, 50%, 25%, 0% control. For secondary analysis, subjects will be asked to report the percentage of control they subjectively feel over the displayed hand. After subjects are comfortable with the apparatus and endorse SA over the displayed hand, they will undergo EEG.
The experimental phase will have five sets of 10 minute recording sessions where the subject is instructed to slowly open and close their hand randomly. The level of control will be changed pseudo-randomly throughout the recording sessions. A control contrast consisting of the subject observing a moving hand will also be integrated into the blocks. An additional control contrast involving the subject moving their hand without visual feedback will also be included. These contrasts will serve in the analysis phase to help eliminate electrophysiological activity related to visual-motor feedback.
A Magnetic Resonance Imaging (MRI) scan of brain will be performed to co-register this EEG data with the anatomical structure. We will integrate physiological (EEG) and anatomical (MRI) data to characterize the regionalization of the task-related brain EEG activity.
Outcome Measures
The primary outcome of this study is the effective connectivity of brain in response to a loss of SA. For this purpose, we will measure the difference of EEG power spectral analysis as well as coherence between 0% and 100 % control. In a secondary analysis, we will investigate the correlation of the EEG measurements with the percent of actual control, and also utilize the individual subject perceptions of percent control during the behavioral training phase as the regressors for activation rather than the objective control settings.
Study design
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects age 18 and older
- Subjects must be right-hand dominant (Edinburgh Handedness Quotient greater than 60)
- Subjects willing to abstain from caffeine or alcohol for 48 hours prior to the EEG study
Key exclusion criteria (7 listed)
- Subjects with any abnormal findings on neurological exam
- Subjects with any history of brain tumor, stroke, head trauma or a vascular malformation as obtained by history or from imaging studies
- Subjects with any history of a severe medical condition, such as cardiovascular disease, which would prevent them from sitting for up to 120 minutes
- Subjects without the capacity to give informed consent
- Subjects with other restrictions which prevent them from undergoing EEG recordings for up to 60 minutes
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 2 Jul 2017.
- Background: PubMed 10637618Gallagher S. Philosophical conceptions of the self: implications for cognitive science. Trends Cogn Sci. 2000 Jan;4(1):14-21. doi: 10.1016/s1364-6613(99)01417-5.
- Background: PubMed 14656508Kircher TT, Leube DT. Self-consciousness, self-agency, and schizophrenia. Conscious Cogn. 2003 Dec;12(4):656-69. doi: 10.1016/s1053-8100(03)00071-0.
- Background: PubMed 11435916Blakemore SJ, Frith CD, Wolpert DM. The cerebellum is involved in predicting the sensory consequences of action. Neuroreport. 2001 Jul 3;12(9):1879-84. doi: 10.1097/00001756-200107030-00023.
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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 Spatiotemporal Patterns, run by National Institute of Neurological Disorders and Stroke (NINDS) 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 3 inclusion and 7 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 2 Jul 2017. 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 NCT00283907, which also lists 3 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 2 Jul 2017.