NCT00357409

Brief Summary

In blind individuals, the occipital cortex becomes capable of processing tactile and auditory information, a phenomenon described as crossmodal plasticity. GABA is the major inhibitory neurotransmitter in the brain and a possible candidate to mediate this form of human plasticity. We intend to use magnetic resonance spectroscopy (MRS) to measure GABA and hypothesize that GABA levels in the occipital cortex of blind humans will be lower than in sighted controls. Such decrease could possibly mediate compensatory changes in the occipital cortex of the blind. Objective Early blind subjects exhibit better tactile acuity than late blinds or sighted individuals. The purpose of the study is the determine GABA levels in the human occipital cortex after long-term light deprivation (blindness). Study Population Our experiments will make use of early blind, late blind, and sighted control subjects. Design Subject will be identified and will receive clinical and neurological examinations at the NIH. MRS studies will be performed at NIH MRI Center with 3Tesla Magnet. Each subject head will be positioned in an adjustable holder (designed for minimal motion and maximal comfort) such that a flat coil lay just below the occipital cortex. The sequence has been described before \[33\]. The individuals who perform the data analysis will be blind to the purpose of the experiments. Outcome measures The concentration of GABA from the 14 ml voxel over the visual cortex will be measured. Edited proton spectrum of GABA will be compared with the edited sub spectrum of creatine for a concentration reference.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2002

Longer than P75 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

February 11, 2002

Completed
4.5 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 27, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2008

Completed
Last Updated

July 2, 2017

Status Verified

March 3, 2008

First QC Date

July 26, 2006

Last Update Submit

June 30, 2017

Conditions

Keywords

GABAOccipitalVisionPlasticityMRSBlind

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All subjects must be between 18 and 55 years of age.
  • Healthy sighted volunteers. Legally blind subjects with blindness secondary to retinal lesions or eye removal acquired at ages earlier than 4 years old (EARLY) and after 13 years of age (LATE). The rationale for the distinction is based in our previous studies that indicate different magnitude of brain plasticity depending on the age of acquisition of blindness.

You may not qualify if:

  • Pregnant women tested after urine pregnancy test.
  • Subjects with metal in the cranium except mouth.
  • Subjects with metal fragments from occupational exposure or surgical clips in or near the brain.
  • Subjects with blood vessel, cochlear or eye implants.
  • Subjects with increased intracranial pressure as evaluated by clinical means.
  • Subjects with cardiac or neural pacemakers.
  • Subjects with intracardiac lines and implanted medication pumps.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (1)

  • Micheva KD, Beaulieu C. Neonatal sensory deprivation induces selective changes in the quantitative distribution of GABA-immunoreactive neurons in the rat barrel field cortex. J Comp Neurol. 1995 Oct 30;361(4):574-84. doi: 10.1002/cne.903610403.

    PMID: 8576415BACKGROUND

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

July 26, 2006

First Posted

July 27, 2006

Study Start

February 11, 2002

Study Completion

March 3, 2008

Last Updated

July 2, 2017

Record last verified: 2008-03-03

Locations