Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00076700
Other study ID # 040110
Secondary ID 04-N-0110
Status Completed
Phase N/A
First received January 31, 2004
Last updated March 3, 2008
Start date January 2004
Est. completion date January 2006

Study information

Verified date January 2006
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 determine if the brain regions in blind people that would normally be involved in vision are used instead to remember touch. Blind people have an enhanced sense of touch compared to sighted people, and they also perform better on tests for certain kinds of memory. This study will examine and compare the results of a touch memory test in blind and sighted people to determine what brain areas are involved in responding to touch.

Blind people and sighted volunteers between 18 and 80 years of age who have no psychiatric problems or neurological problems (other than blindness) may be eligible for this study. Candidates are screened with a medical interview and examination.

Participants undergo one or both of the following procedures:

Behavioral experiment

Sighted participants are blindfolded during this experiment. Subjects sit comfortably in front of a table. They are presented with a number of surfaces placed on a table one at a time and are given 10 seconds to feel each surface with the index finger on their dominant hand. They must concentrate and memorize the surfaces as best they can. After a 15-minute break, they are again presented with a series of surfaces and given 10 seconds to feel each one. This time, they must say as quickly as possibly whether the surface is one they touched previously or is a new surface.

Functional MRI

MRI uses a strong magnetic field and radio waves to obtain images of body organs and tissues. In this study, subjects undergo MRI scanning of the brain while performing the same touch test described above. For the MRI, the subject lies on a table that slides into the scanner. The MRI machine detects change in the brain regions involved in performing the task.


Description:

In the blind, areas of the brain that would normally respond to visual stimuli instead of process information from other sensory modalities such as the somatosensory and auditory domains. Recent studies have shown that the visual cortex of the blind participates in higher-order processing of auditory information including verb generation and retrieval of verbal memories. Because tactile information plays a similarly crucial role when vision is missing (i.e. to read Braille), it has been suggested that the ability to encode and recall tactile information in the blind is superior to that in the sighted.

OBJECTIVES:

The first objective of this protocol is to determine if tactile memory is superior in early blind subjects relative to that in late blind and sighted control subjects.

The second objective is to determine if the visual cortex of blind people can participate in higher-order processing of tactile information such as tactile encoding recognition.

STUDY POPULATION:

Our experiments will make use of early blind, late blind, and sighted control subjects.

DESIGN:

Experiment 1: We will quantify the ability of our study populations to encode into and retrieve from episodic tactile memory. Subjects will be presented with a series of surfaces that they are to palpate and commit to memory, after which they will rest for ten to fifteen minutes. The old surfaces will then be presented again with a same number of new surfaces randomly interleaved. Subjects are to discriminate old from new surfaces.

Experiment 2: We will identify cortical areas associated with successful tactile memory encoding and retrieval in blind individuals and sighted controls using functional magnetic resonance imaging (fMRI). Subjects will perform the memory task from Experiment 1 while in the MRI machine.

OUTCOME MEASURES:

Experiment 1: The primary outcome measure will be recognition memory, a corrected measure of the number of old stimuli correctly remembered.

Experiment 2: The primary outcome measure will be the number of voxels significantly activated in primary visual cortex in early blind subjects as compared to late blind subjects and sighted controls.

We expect the magnitude of visual cortex activation in the early blind during a tactile memory task to correlate with superior performance on the task.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date January 2006
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility INCLUSION CRITERIA:

Early Blind Subjects: Only compliant early blind subjects between the ages of 18 and 80 years who have little to no visual perception due to diseases affecting the peripheral components of the visual system, i.e., blind subjects without any further neurological problems, and with normal MRI brain scans, will be selected.

Late Blind Subjects: Only compliant late blind subjects who have lost their vision after age 4 years due to diseases affecting the peripheral components of the visual system, i.e., blind subjects without any further neurological problems, and with normal MRI brain scans, will be selected.

Sighted controls: Only compliant adult healthy volunteers between the ages of 18 and 80 years with no history of neurological and psychiatric illness who are able to concentrate and to perform simple attention tasks are eligible.

Blind subjects: Early and late blind subjects (aged 18 to 80) will be included in this protocol.

Sighted subjects: Healthy sighted (normal or corrected-to normal vision) matched in age, sex, and handedness to the early blind subjects.

EXCLUSION CRITERIA:

Exclusion criteria for the study will be ny current medical or surgical condition or psychiatric or neurological illness.

Furthermore, any individual who is on medication with potential influence on nervous system function, who has a history of surgery with metallic implants or known history of metallic particles in the eye, cardiac pacemaker, intracardiac lines, neural stimulators, cochlear implants, pregnancy, or history of drug abuse will be excluded from the study.

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)

Amedi A, Malach R, Hendler T, Peled S, Zohary E. Visuo-haptic object-related activation in the ventral visual pathway. Nat Neurosci. 2001 Mar;4(3):324-30. — View Citation

Amedi A, Raz N, Pianka P, Malach R, Zohary E. Early 'visual' cortex activation correlates with superior verbal memory performance in the blind. Nat Neurosci. 2003 Jul;6(7):758-66. — View Citation

Bailes SM, Lambert RM. Cognitive aspects of haptic form recognition by blind and sighted subjects. Br J Psychol. 1986 Nov;77 ( Pt 4):451-8. — View Citation

See also
  Status Clinical Trial Phase
Active, not recruiting NCT02393118 - A Study to Evaluate the BrainPort Vision Device in Individuals Blinded by Traumatic Injury N/A
Terminated NCT00262509 - Emergency Egress and Information System for Persons With Vision Loss N/A
Terminated NCT00691444 - Blind Child Melatonin Treatment Study N/A
Recruiting NCT06237829 - Testing Tactile Aids With Blind Subjects N/A
Completed NCT00829036 - Wayfinding Information Access System for People With Vision Loss N/A
Completed NCT02643238 - Continued Study of Artificial Vision: Evaluation of the BrainPort® System and Investigation of Visual Ambulation N/A
Completed NCT01488786 - A Study to Evaluate the BrainPort® Vision Device in Subjects Who Are Blind N/A
Recruiting NCT00403143 - Do Blue-Blocking Lenses Block Blue Colour From Our Lives? N/A
Recruiting NCT06451172 - Novel Antisense Oligonucleotide Eye Drops for Treating Antibiotic-Resistant Bacterial Keratitis Early Phase 1
Recruiting NCT04725760 - Evaluation of the Efficacy of the BrainPort Vision Pro on the Performance of Daily Activities in the Profoundly Blind French Population N/A
Recruiting NCT02983370 - Development of a Cortical Visual Neuroprosthesis for the Blind N/A
Not yet recruiting NCT06070467 - Holistic Mixed Approaches to Capture the Real Life of Children With Rare Eye Diseases
Completed NCT00920231 - Computer Vision System for the Blind Veteran Phase 1
Completed NCT01109576 - Workshops for Veterans With Vision and Hearing Loss Phase 0
Terminated NCT00795236 - Melatonin Studies of Totally Blind Children N/A
Terminated NCT00634972 - Efficient Study of ACULAR in Inhibiting Proliferative Retinopathy in Prematurity Phase 4
Enrolling by invitation NCT06364605 - MySpace: the Role of Vision in Representing Space N/A
Terminated NCT03913130 - Extension Study to Study PQ-110-001 (NCT03140969) Phase 1/Phase 2
Not yet recruiting NCT05806684 - Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants: a Retrospective Study.
Completed NCT03753893 - Ocular Manifestations in Rheumatic Diseases