NCT00028210

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2001

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

December 17, 2001

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2001

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2004

Completed
Last Updated

March 4, 2008

Status Verified

March 1, 2004

First QC Date

December 17, 2001

Last Update Submit

March 3, 2008

Conditions

Keywords

AmputeePlasticitySomatosensoryUpper Limb AmputationTactile PerformanceCortical ReorganizationHealthy VolunteerHVNormal Control

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Neurological or psychiatric disease
  • Excessive callus at the palm of the fingers
  • Subjects, who are unable to perform or understand the task

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institute of Neurological Disorders and Stroke (NINDS)

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • 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.

    PMID: 7696611BACKGROUND
  • Flor 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.

    PMID: 7777055BACKGROUND
  • Kaas 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.

    PMID: 6340591BACKGROUND

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

December 17, 2001

First Posted

December 18, 2001

Study Start

December 1, 2001

Study Completion

March 1, 2004

Last Updated

March 4, 2008

Record last verified: 2004-03

Locations