AmputationNCT00028210
Enhanced Tactile (Touch) Spatial Acuity in Upper Limb Amputees
An observational study of Amputation, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will examine whether tactile (touch) abilities at the lip are more acute in people with upper limb amputation compared with healthy normal volunteers. People with an amputated upper limb have an expanded brain representation of the lip that may correlate with heightened tactile spatial acuity. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Amputation
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2001to Mar 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Normal volunteers who are willing and able to stay relaxed and collaborative for a period of up to 2 hours.
- Subjects with upper limb amputation more than one year before testing.
Who cannot join
- Neurological or psychiatric disease
- Excessive callus at the palm of the fingers
- Subjects, who are unable to perform or understand the task
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Neurological Disorders and Stroke (NINDS)
Bethesda, Maryland, 20892
About this study
Official title: Enhancement of Tactile Spatial Acuity in Upper Limb Amputees
This study will examine whether tactile (touch) abilities at the lip are more acute in people with upper limb amputation compared with healthy normal volunteers. People with an amputated upper limb have an expanded brain representation of the lip that may correlate with heightened tactile spatial acuity.
Normal volunteers will be recruited for this study. Candidates will be screened with physical and neurological examinations. (Amputee volunteers will be studied at the amputee clinic at the University of Tubingen, Germany.)
Read more
Participants will sit comfortably in a chair, wearing a blindfold, during the following experiments:
- Plastic domes with grooves are placed on parts of the lower lip on either side for a few seconds. The volunteer is then asked to identify the direction of the grooves relative to the long axis of the lip.
- The participant's arm is placed in a cast and the index finger is immobilized. The same test done on the lip is repeated on the distal part of the index finger.
Each part of the test lasts about 20 minutes, and the entire experiment takes about 2 hours.
Read the detailed description
Upper limb amputation leads to expansion of the cortical representation of the lip into the adjacent deafferented hand representation. It is conceivable that this enlargement of the lip representation may translate into a behavioral gain. The purpose of this protocol is to test the hypothesis that upper limb amputation in humans results in higher tactile spatial acuity at the lip. This would represent the first demonstration of chronic deafferentation-induced behavioral gains within the somatosensory system.
- Conditions
- Amputation
- Keywords
- Amputee, Plasticity, Somatosensory, Upper Limb Amputation, Tactile Performance, Cortical Reorganization, Healthy Volunteer, HV, Normal Control
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2001 (estimated)
- Study startDec 2001
- Study completionMar 2004
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 AmputationStudies 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
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00028210
- Sponsor's protocol ID
- 020067
- Other IDs
- 02-N-0067
- Status last verified
- Mar 2004
- First submitted
- 17 Dec 2001
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Elbert T, Flor H, Birbaumer N, Knecht S, Hampson S, Larbig W, Taub E. Extensive reorganization of the somatosensory cortex in adult humans after nervous system injury. Neuroreport. 1994 Dec 20;5(18):2593-7. doi: 10.1097/00001756-199412000-00047.
PubMed 7696611Flor H, Elbert T, Knecht S, Wienbruch C, Pantev C, Birbaumer N, Larbig W, Taub E. Phantom-limb pain as a perceptual correlate of cortical reorganization following arm amputation. Nature. 1995 Jun 8;375(6531):482-4. doi: 10.1038/375482a0.
PubMed 7777055Kaas JH, Merzenich MM, Killackey HP. The reorganization of somatosensory cortex following peripheral nerve damage in adult and developing mammals. Annu Rev Neurosci. 1983;6:325-56. doi: 10.1146/annurev.ne.06.030183.001545. No abstract available.
PubMed 6340591
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Tactile Spatial Acuity in Upper Limb Amputees
- ClinicalTrials.gov ID
- NCT00028210
- Acronym / sponsor ID
- 020067
- Conditions
- Amputation
- Keywords
- Amputee, Plasticity, Somatosensory, Upper Limb Amputation, Tactile Performance, Cortical Reorganization, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- Dec 2001
- Study completion
- Mar 2004
- First posted
- 18 Dec 2001 (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 will examine whether tactile (touch) abilities at the lip are more acute in people with upper limb amputation compared with healthy normal volunteers. People with an amputated upper limb have an expanded brain representation of the lip that may correlate with heightened tactile spatial acuity.
Normal volunteers will be recruited for this study. Candidates will be screened with physical and neurological examinations. (Amputee volunteers will be studied at the amputee clinic at the University of Tubingen, Germany.)
Participants will sit comfortably in a chair, wearing a blindfold, during the following experiments:
- Plastic domes with grooves are placed on parts of the lower lip on either side for a few seconds. The volunteer is then asked to identify the direction of the grooves relative to the long axis of the lip.
- The participant's arm is placed in a cast and the index finger is immobilized. The same test done on the lip is repeated on the distal part of the index finger.
Each part of the test lasts about 20 minutes, and the entire experiment takes about 2 hours.
Detailed description
Upper limb amputation leads to expansion of the cortical representation of the lip into the adjacent deafferented hand representation. It is conceivable that this enlargement of the lip representation may translate into a behavioral gain. The purpose of this protocol is to test the hypothesis that upper limb amputation in humans results in higher tactile spatial acuity at the lip. This would represent the first demonstration of chronic deafferentation-induced behavioral gains within the somatosensory system.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Normal volunteers who are willing and able to stay relaxed and collaborative for a period of up to 2 hours.
- Subjects with upper limb amputation more than one year before testing.
Key exclusion criteria (3 listed)
- Neurological or psychiatric disease
- Excessive callus at the palm of the fingers
- Subjects, who are unable to perform or understand the task
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 4 Mar 2008.
- Background: PubMed 7696611Elbert T, Flor H, Birbaumer N, Knecht S, Hampson S, Larbig W, Taub E. Extensive reorganization of the somatosensory cortex in adult humans after nervous system injury. Neuroreport. 1994 Dec 20;5(18):2593-7. doi: 10.1097/00001756-199412000-00047.
- Background: PubMed 7777055Flor H, Elbert T, Knecht S, Wienbruch C, Pantev C, Birbaumer N, Larbig W, Taub E. Phantom-limb pain as a perceptual correlate of cortical reorganization following arm amputation. Nature. 1995 Jun 8;375(6531):482-4. doi: 10.1038/375482a0.
- Background: PubMed 6340591Kaas JH, Merzenich MM, Killackey HP. The reorganization of somatosensory cortex following peripheral nerve damage in adult and developing mammals. Annu Rev Neurosci. 1983;6:325-56. doi: 10.1146/annurev.ne.06.030183.001545. No abstract available.
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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 Amputation, 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 2 inclusion and 3 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 4 Mar 2008. 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 NCT00028210, 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 4 Mar 2008.