Clinical trial NCT01105845: Genetics of Motor Learning
Official title: Genetics of Motor Learning
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Parkinson s Disease
Dystonic Disorders
Focal Dystonia
Movement Disorders
Keywords: Motor Learning
Genetic Analysis
BDNF
Parkinson Disease
Movement Disorders
Dystonia
Healthy Volunteer
HV
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2010-04-19
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief 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....

Detailed description: OBJECTIVE:\<TAB\>

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: \<TAB\>

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:\<TAB\>

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.

Eligibility criteria: * INCLUSION CRITERIA:

\<TAB\>

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

\<TAB\>

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.

Primary outcomes:
measure: Genetic polymorphism frequency (e.g. BNDF Va166Met) compared to measures of motor learning (e.g. reaction time or fMRI BOLD signal change)
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center, 9000 Rockville Pike
state: Maryland
Study officials:
affiliation: National Institute of Neurological Disorders and Stroke (NINDS)
name: Mark Hallett, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. doi: 10.1016/s0092-8674(03)00035-7.