Upper Limb AmputeesNCT00458757
The Effect of Amputation on Spatial Visual Representation in Peripersonal Space
An observational study of Upper Limb Amputees, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
In this study, we wish to find behavioral evidence for the question whether an amputation of the arm can lead to changes in visual perception or motor responses to objects in peripersonal space. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Upper Limb Amputees
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2007to not given
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: In this experiment we plan to employ a paradigm which is inspired by the affordance effect, originally introduced by Tucker and Elice (1998): we will present subjects with brief images of either manipulable or non manipulable objects in either the left or right visual field. The subjects will be required to determine whether the object contains a metal or not, by moving either their left or their right shoulder. We predict that while the control group of normal subjects would show a congruency effect (that is superior performance (faster and more accurate responses) when the responding shoulder is congruent with the position of the objects, the amputees will show spatial biases towards the non-amputated side. This effect should be more prominent for the manipulable objects.
Who may be able to join
- Upper limb amputee, amputation above wrist.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Israel1 site
Neurobiology Dep., Life Sciences Institute, Hebrew Uni.
Jerusalem, 91904
About this study
Official title: The Effect of Upper Arm Amputation and the Use of Prosthetics on Spatial Visual Representation in Peripersonal Space - a Behavioural Study
In this study, we wish to find behavioral evidence for the question whether an amputation of the arm can lead to changes in visual perception or motor responses to objects in peripersonal space. We hypothesize that changes in the motor and somatosensory hand-related cortices following amputation might lead to changes in parietal hand-related areas. The consequence of these parietal changes should be reflected behaviorally in reduced perception/attention/responses to hand-related objects in the space ipsilateral to the amputation. We further hypothesize that the use of prosthetics may provide the necessary visual feedback to maintain an intact hand representation and therefore lead to lesser cortical reorganization in both visual and somatosensory cortical areas.
Read the detailed description
In a recent fMRI study (Makin TR. et al., J. Neurosci. 2007), we found extended cortical representation for a visual stimulus provided that it is presented close to the hand. It is therefore interesting to ask whether changes in the brain following limb amputation might induce changes in the amputees' perception of the body and consequently it's surrounding. In this study, we wish to find behavioral evidence for the question whether an amputation of the arm can lead to changes in visual perception or motor responses to objects in peripersonal space. We hypothesize that changes in the motor and somatosensory hand-related cortices following amputation might lead to changes in parietal hand-related areas. Consequently, we expect to find reduced perception/attention/responses to hand-related objects in the space ipsilateral to the amputation.
In this experiment we plan to employ a paradigm which is inspired by the affordance effect, originally introduced by Tucker and Elice (1998): we will present subjects with brief images of either manipulable or non manipulable objects in either the left or right visual field. The subjects will be required to determine whether the object contains a metal or not, by moving either their left or their right shoulder. We predict that while the control group of normal subjects would show a congruency effect (that is superior performance (faster and more accurate responses) when the responding shoulder is congruent with the position of the objects, the amputees will show spatial biases towards the non-amputated side. This effect should be more prominent for the manipulable objects.
- Conditions
- Upper Limb Amputees
- Keywords
- Amputees, Affordance, Peripersonal space, Pseudo neglect, Reaching, Spatial, visual
- Medical subject headings
- Personal Space
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2007 (estimated)
- Study startNov 2007
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 Upper Limb AmputeesStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Investigators
- Isabella Schuartz, MD, Principal investigator, Rehabilitation Dep. Hadassah Medical Hospital, Mount Scopus, Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00458757
- Sponsor's protocol ID
- 090767-amputy-HMO-CTIL
- Status last verified
- Mar 2007
- First submitted
- 10 Apr 2007
- Last updated
- 30 Nov 2017
- Results posted
- No
Publications
Makin TR, Holmes NP, Zohary E. Is that near my hand? Multisensory representation of peripersonal space in human intraparietal sulcus. J Neurosci. 2007 Jan 24;27(4):731-40. doi: 10.1523/JNEUROSCI.3653-06.2007.
PubMed 17251412Tucker M, Ellis R. On the relations between seen objects and components of potential actions. J Exp Psychol Hum Percept Perform. 1998 Jun;24(3):830-46. doi: 10.1037//0096-1523.24.3.830.
PubMed 9627419
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Upper Arm Amputation and the Use of Prosthetics on Spatial Visual Representation in Peripersonal Space - a Behavioural Study
- ClinicalTrials.gov ID
- NCT00458757
- Acronym / sponsor ID
- 090767-amputy-HMO-CTIL
- Conditions
- Upper Limb Amputees
- Keywords
- Amputees, Affordance, Peripersonal space, Pseudo neglect, Reaching, Spatial, visual
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Nov 2007
- First posted
- 11 Apr 2007 (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.
In this study, we wish to find behavioral evidence for the question whether an amputation of the arm can lead to changes in visual perception or motor responses to objects in peripersonal space. We hypothesize that changes in the motor and somatosensory hand-related cortices following amputation might lead to changes in parietal hand-related areas. The consequence of these parietal changes should be reflected behaviorally in reduced perception/attention/responses to hand-related objects in the space ipsilateral to the amputation. We further hypothesize that the use of prosthetics may provide the necessary visual feedback to maintain an intact hand representation and therefore lead to lesser cortical reorganization in both visual and somatosensory cortical areas.
Detailed description
In a recent fMRI study (Makin TR. et al., J. Neurosci. 2007), we found extended cortical representation for a visual stimulus provided that it is presented close to the hand. It is therefore interesting to ask whether changes in the brain following limb amputation might induce changes in the amputees' perception of the body and consequently it's surrounding. In this study, we wish to find behavioral evidence for the question whether an amputation of the arm can lead to changes in visual perception or motor responses to objects in peripersonal space. We hypothesize that changes in the motor and somatosensory hand-related cortices following amputation might lead to changes in parietal hand-related areas. Consequently, we expect to find reduced perception/attention/responses to hand-related objects in the space ipsilateral to the amputation.
In this experiment we plan to employ a paradigm which is inspired by the affordance effect, originally introduced by Tucker and Elice (1998): we will present subjects with brief images of either manipulable or non manipulable objects in either the left or right visual field. The subjects will be required to determine whether the object contains a metal or not, by moving either their left or their right shoulder. We predict that while the control group of normal subjects would show a congruency effect (that is superior performance (faster and more accurate responses) when the responding shoulder is congruent with the position of the objects, the amputees will show spatial biases towards the non-amputated side. This effect should be more prominent for the manipulable objects.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- In this experiment we plan to employ a paradigm which is inspired by the affordance effect, originally introduced by Tucker and Elice (1998): we will present subjects with brief images of either manipulable or non manipulable objects in either the left or right visual field. The subjects will be required to determine whether the object contains a metal or not, by moving either their left or their right shoulder. We predict that while the control group of normal subjects would show a congruency effect (that is superior performance (faster and more accurate responses) when the responding shoulder is congruent with the position of the objects, the amputees will show spatial biases towards the non-amputated side. This effect should be more prominent for the manipulable objects.
Key inclusion criteria (1 listed)
- Upper limb amputee, amputation above wrist.
Key exclusion criteria (0 listed)
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
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2017.
- Background: PubMed 17251412Makin TR, Holmes NP, Zohary E. Is that near my hand? Multisensory representation of peripersonal space in human intraparietal sulcus. J Neurosci. 2007 Jan 24;27(4):731-40. doi: 10.1523/JNEUROSCI.3653-06.2007.
- Background: PubMed 9627419Tucker M, Ellis R. On the relations between seen objects and components of potential actions. J Exp Psychol Hum Percept Perform. 1998 Jun;24(3):830-46. doi: 10.1037//0096-1523.24.3.830.
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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.
Isabella Schuartz, MD principal investigator
Rehabilitation Dep. Hadassah Medical Hospital, Mount Scopus, Jerusalem
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 Upper Limb Amputees, run by Hadassah Medical Organization at 1 site in Israel.
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 1 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 30 Nov 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Isabella Schuartz, MD (00 972 50 8573783, isabellas@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00458757, 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 30 Nov 2017.