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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01105845
Other study ID # 100092
Secondary ID 10-N-0092
Status Terminated
Phase
First received
Last updated
Start date April 14, 2010
Est. completion date December 21, 2015

Study information

Verified date December 21, 2015
Source National Institutes of Health Clinical Center (CC)
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Background:

- New studies in human genetics have revealed information about genetic connections to memory and motor behavior. Researchers are interested in investigating the role of genetics in motor learning, in conjunction with related studies taking place in the Human Motor Control Section of the National Institute of Neurological Diseases and Stroke (NINDS). Participants in motor learning studies conducted at NINDS will be asked to provide blood samples for further evaluation.

Objectives:

- To create a repository of blood samples from patients and healthy subjects who are participating in NINDS motor learning studies.

Eligibility:

- Individuals between 18 and 100 years of age who are or will be participating in motor learning research studies at the National Institutes of Health.

Design:

- Blood draws for genetic testing will usually be done on the same day as the motor learning study. Participants will provide one blood sample for research.

- No treatment will be provided under this study....


Description:

OBJECTIVE:

The objective of this study is to create a bio-repository of blood samples from patients and healthy subjects who are participating in NINDS motor learning studies. Blood will be analyzed for BDNF and samples stored for future genetic studies. . A variety of genes that may affect motor learning are being increasingly identified, and variations among these genes, referred to as polymorphisms, may help explain individual differences.

STUDY POPULATION:

We will enroll up to five hundred healthy volunteers and five hundred volunteers with movement difficulties who are between the ages of 18 and 100 and who are already participating, or will be participating, in other protocols dealing with motor learning research studies at the National Institutes of Health (NIH).

DESIGN:

This is an observational and repository protocol that involves a single blood sample for genetic analysis. This will allow the genetic characterization of subjects participating in motor learning protocols to be analyzed and tested for the role of genetics in motor learning results.

OUTCOME MEASURE:

We will compare genetic variations with the different behavioral, electrophysiologic, imaging, or other outcomes acquired in the associated motor learning studies. Thus, we will determine whether specific polymorphisms are associated with different measures of motor learning.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date December 21, 2015
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility - INCLUSION CRITERIA:

<TAB>

Anyone aged 18-100 years and participating in a motor learning study at NIH is eligible to participate in this study.

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EXCLUSION CRITERIA:

Anyone with impaired decisional capacity, inability to provide informed consent, or who is unable to safely give blood is not eligible to participate in this study.

Study Design


Locations

Country Name City State
United States National Institutes of Health Clinical Center, 9000 Rockville Pike 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)

Brunoni AR, Lopes M, Fregni F. A systematic review and meta-analysis of clinical studies on major depression and BDNF levels: implications for the role of neuroplasticity in depression. Int J Neuropsychopharmacol. 2008 Dec;11(8):1169-80. doi: 10.1017/S1461145708009309. Epub 2008 Aug 28. Review. — View Citation

Cheeran B, Talelli P, Mori F, Koch G, Suppa A, Edwards M, Houlden H, Bhatia K, Greenwood R, Rothwell JC. A common polymorphism in the brain-derived neurotrophic factor gene (BDNF) modulates human cortical plasticity and the response to rTMS. J Physiol. 2008 Dec 1;586(23):5717-25. doi: 10.1113/jphysiol.2008.159905. Epub 2008 Oct 9. — View Citation

Egan MF, Kojima M, Callicott JH, Goldberg TE, Kolachana BS, Bertolino A, Zaitsev E, Gold B, Goldman D, Dean M, Lu B, Weinberger DR. The BDNF val66met polymorphism affects activity-dependent secretion of BDNF and human memory and hippocampal function. Cell. 2003 Jan 24;112(2):257-69. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Genetic polymorphism frequency (e.g. BNDF Va166Met) compared to measures of motor learning (e.g. reaction time or fMRI BOLD signal change)
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