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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00028210
Other study ID # 020067
Secondary ID 02-N-0067
Status Completed
Phase N/A
First received December 17, 2001
Last updated March 3, 2008
Start date December 2001
Est. completion date March 2004

Study information

Verified date March 2004
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical 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.

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date March 2004
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

Neurological or psychiatric disease

Excessive callus at the palm of the fingers

Subjects, who are unable to perform or understand the task

Study Design

N/A


Related Conditions & MeSH terms


Locations

Country Name City State
United States National Institute of Neurological Disorders and Stroke (NINDS) Bethesda Maryland

Sponsors (1)

Lead Sponsor Collaborator
National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. Review. — View Citation

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