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| Tracking Information | |
|---|---|
| First Received Date ICMJE | July 26, 2006 |
| Last Updated Date | March 7, 2008 |
| Start Date ICMJE | February 2002 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00357409 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | GABA Levels in the Brains of Blind People |
| Official Title ICMJE | GABA Levels in the Occipital Cortex of Blind Human Subjects |
| 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. |
| Detailed Description | 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 Subjects 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. 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. |
| Study Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * | 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. |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 39 |
| Completion Date | March 2008 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE |
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. EXCLUSION CRITERIA: Exclusion criteria will be those of MRI procedures: 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. |
| Gender | Both |
| Ages | 18 Years to 55 Years |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00357409 |
| Responsible Party | |
| Study ID Numbers ICMJE | 020124, 02-N-0124 |
| Study Sponsor ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | March 2008 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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