Parkinson s DiseaseNCT01105845
Genetics of Motor Learning
An observational study of Parkinson s Disease and Dystonic Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Parkinson s Disease, Dystonic Disorders, Focal Dystonia
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Apr 2010to 21 Dec 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- <TAB>
- Anyone aged 18-100 years and participating in a motor learning study at NIH is eligible to participate in this study.
- <TAB>
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
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.
Read more
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....
Read the 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.
- Keywords
- Motor Learning, Genetic Analysis, BDNF, Parkinson Disease, Movement Disorders, Dystonia, Healthy Volunteer, HV
- Medical subject headings
- Parkinson Disease, Dystonic Disorders, Movement Disorders, Dystonia
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic polymorphism frequency (e.g. BNDF Va166Met) compared to measures of motor learning (e.g. reaction time or fMRI BOLD signal change)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2010 (estimated)
- Study start14 Apr 2010
- Study completion21 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parkinson s DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Mark Hallett, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01105845
- Sponsor's protocol ID
- 100092
- Other IDs
- 10-N-0092
- Status last verified
- 21 Dec 2015
- First submitted
- 16 Apr 2010
- Last updated
- 22 Nov 2019
- Results posted
- No
Publications
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.
PubMed 18752720Cheeran 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.
PubMed 18845611Egan 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.
PubMed 12553913
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetics of Motor Learning
- ClinicalTrials.gov ID
- NCT01105845
- Acronym / sponsor ID
- 100092
- Keywords
- Motor Learning, Genetic Analysis, BDNF, Parkinson Disease, Movement Disorders, Dystonia, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 5 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 14 Apr 2010
- Study completion
- 21 Dec 2015
- First posted
- 19 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- <TAB>
- Anyone aged 18-100 years and participating in a motor learning study at NIH is eligible to participate in this study.
- <TAB>
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Genetic polymorphism frequency (e.g. BNDF Va166Met) compared to measures of motor learning (e.g. reaction time or fMRI BOLD signal change)
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2019.
- Background: PubMed 18752720Brunoni 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.
- Background: PubMed 18845611Cheeran 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.
- Background: PubMed 12553913Egan 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Hallett, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson s Disease and Dystonic Disorders, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic polymorphism frequency (e.g. BNDF Va166Met) compared to measures of motor learning (e.g. reaction time or fMRI BOLD signal change). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01105845, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2019.