BDNFBDNFNCT02074696
BDNF and Motor Learning
An observational study of BDNF and Polymorphism, Genetic, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of the study is to assess the status of brain-derived neurotrophic factor brain (BDNF) and how the brain behaves in response to skill acquisition. Specifically we will investigate the relationship of the status of BDNF with cortical excitability changes and learning that occur during a motor training… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- BDNF, Polymorphism, Genetic
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to May 2014
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Healthy adults
Who may be able to join
- 18-45 years
- no past history of psychiatric or neurologic disease.
Who cannot join
- any neuromuscular disorder that impairs upper extremity motion or seizure history
- Pregnancy
- Indwelling metal or medical device that are incompatible with TMS testing.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55414
About this study
Official title: The Effect of BDNF on Motor Learning
The purpose of the study is to assess the status of brain-derived neurotrophic factor brain (BDNF) and how the brain behaves in response to skill acquisition. Specifically we will investigate the relationship of the status of BDNF with cortical excitability changes and learning that occur during a motor training paradigm. We aim to 1) determine cortical excitability changes by using transcranial magnetic stimulation (TMS) before and after training; 2) to determine finger tracking accuracy before and after training; and 3) determine the presence of BDNF polymorphism in each participant.
We are testing healthy adults in this study, and eventually would like to apply to persons who have neurologic disorders such as stroke or dystonia. By applying a magnetic field to the outside of the head, electrical currents are produced within the brain that can stimulate brain tissue. Using TMS, the brain can be studied to gain a greater understanding of the mechanisms associated with cortical excitability in healthy and patient populations. There is limited knowledge of what influence genetic biomarkers such as BDNF have on cortical excitability changes within the cortex following learning. Studies have indicated that people without this certain gene are less likely to show changes in brain excitability during TMS and during motor learning than people with this gene
Read the detailed description
Subjects and Design: A pretest/posttest design will be used. A convenience sample of healthy college students will be studied and will undergo an initial screening by the PI or Co-Investigators consisting of medical history and neurologic disorder review to assess safety and qualifications to participate.
Inclusion/ Exclusion Criteria: Inclusion criteria include ages between 18-45 years and no past history of psychiatric or neurologic disease. Exclusion criteria include subjects with any neuromuscular disorder that impairs upper extremity motion or seizure history. Subjects cannot be pregnant nor have indwelling metal or medical devices that are incompatible with TMS testing.
With the subject seated in a supportive chair, the subject's skin will be cleaned surrounding the first doral interoseus belly and dorsum of the hand. Next small surface electromyographic (EMG) electrodes will be attached at the muscle belly and tendon. A ground electrode will be placed on the dorsum of the hand or wrist.
Next, the threshold for TMS activation of the target muscle will be determined. To find the optimal position for activating the first dorsal interosseous muscle, we will use a 70-mm figure-eight TMS coil connected to a Magstim rapid magnetic stimulator. The coil will be handheld on the scalp over the approximate area of the primary motor cortex (M1) in the contralateral hemisphere to the recording electrode, and moved systematically to find the optimal position. Single-pulse magnetic stimuli will be delivered manually at approximately 0.1 Hz starting at an intensity of 50% of the stimulator maximum. This level will be adjusted systematically until the resting motor threshold is found, defined as the minimum intensity required to elicit a motor evoked potential (MEP) >50 µV peak-to-peak in at least 5 of 10 trials with the target muscle at rest. Various cortical excitability measures will be collected lasting approximately 20 minutes.
Finger tracking/training will be provided for 30 minutes under the supervision of the PI or Co-I. Subjects will wear a finger electrogoniometer at the index finger metacarpophalangeal (MP) joint. Subjects will use flexion/extension movements of the respective joint to track waveforms on a computer screen. The training would consist of 30 blocks of tracking trials. Each block will consist of 3 trials. The protocol parameters for different blocks will differ in waveform, amplitude, frequency, trial duration, and joint position. For example, a square wave would involve a different movement pattern execution as opposed to a triangular wave. The waveforms may also differ on the forearm position to create "stimulus-response compatible" or "stimulus-response incompatible" conditions. For example, a stimulus-response incompatible joint position would involve extending and flexing the joint (finger MP or elbow) in the horizontal plane to produce cursor movements in the vertical plane. All these factors challenge the individual's capabilities to problem solve to achieve optimum learning.
Following training and accuracy testing, cortical excitability measures will be collected again lasting approximately 20 minutes. Lastly, a saliva sample will be collected for genetic screening for brain derived neurotrophic factor (BDNF) polymorphism. We will collect approximately 2 ml (less than one-half teaspoon) of saliva by asking the subject to spit into a tube. It may take up to 30 minutes to provide a saliva sample, however, most people typically require less time (approximately 5 minutes).
- Conditions
- BDNF, Polymorphism, Genetic
- Keywords
- brain derived neurotrophic factor
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy Index
A computer quantified tracking performance measure in each test. This is a calculation of accuracy by using the equation: AI = 100(P-E)/P. Where E is the root mean square (r.m.s.) error between the target line and the response line, and P is the size of the individual's target pattern, calculated as the r.m.s. difference between the sine wave and the midline separating the upper and lower phases of the sine wave. The magnitude of P is determined by the scale of the vertical axis, which is the subject's range of finger motion. Therefore, the AI is normalized to each subject's own range of motion and takes into account any differences between subjects in the excursion of the tracking target. The maximum possible score is 100%. Negative scores occur when the response line is so distant from the target that it falls on the opposite side of the midline.
Measured: Day 1: posttest after training
Secondary outcomes (2)
Cortical Excitability
Cortical excitability will be measured with transcranial magnetic stimulation (TMS) single and paired pulse stimulation to measure short-interval intracortical inhibition (SICI), cortical silent period (CSP) and motor evoked potential (MEP) amplitude.
Measured: Day 1: baseline
Cortical Excitability
Cortical excitability will be measured with transcranial magnetic stimulation (TMS) single and paired pulse stimulation to measure short-interval intracortical inhibition (SICI), cortical silent period (CSP) and motor evoked potential (MEP) amplitude.
Measured: Day 1: posttest
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2014 (estimated)
- Study startApr 2014
- Primary completionMay 2014
- Study completionMay 2014
Why it stopped: Site unable to complete full data collection/protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BDNFStudies 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
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Teresa J Kimberley, PhD, PT, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02074696
- Sponsor's protocol ID
- 1401M46962
- Acronym
- BDNF
- Status last verified
- May 2017
- First submitted
- 26 Feb 2014
- Last updated
- 12 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of BDNF on Motor Learning
- ClinicalTrials.gov ID
- NCT02074696
- Acronym / sponsor ID
- BDNF / 1401M46962
- Conditions
- BDNF, Polymorphism, Genetic
- Keywords
- brain derived neurotrophic factor
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Site unable to complete full data collection/protocol
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Apr 2014 (actual)
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Feb 2014 (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.
The purpose of the study is to assess the status of brain-derived neurotrophic factor brain (BDNF) and how the brain behaves in response to skill acquisition. Specifically we will investigate the relationship of the status of BDNF with cortical excitability changes and learning that occur during a motor training paradigm. We aim to 1) determine cortical excitability changes by using transcranial magnetic stimulation (TMS) before and after training; 2) to determine finger tracking accuracy before and after training; and 3) determine the presence of BDNF polymorphism in each participant.
We are testing healthy adults in this study, and eventually would like to apply to persons who have neurologic disorders such as stroke or dystonia. By applying a magnetic field to the outside of the head, electrical currents are produced within the brain that can stimulate brain tissue. Using TMS, the brain can be studied to gain a greater understanding of the mechanisms associated with cortical excitability in healthy and patient populations. There is limited knowledge of what influence genetic biomarkers such as BDNF have on cortical excitability changes within the cortex following learning. Studies have indicated that people without this certain gene are less likely to show changes in brain excitability during TMS and during motor learning than people with this gene
Detailed description
Subjects and Design: A pretest/posttest design will be used. A convenience sample of healthy college students will be studied and will undergo an initial screening by the PI or Co-Investigators consisting of medical history and neurologic disorder review to assess safety and qualifications to participate.
Inclusion/ Exclusion Criteria: Inclusion criteria include ages between 18-45 years and no past history of psychiatric or neurologic disease. Exclusion criteria include subjects with any neuromuscular disorder that impairs upper extremity motion or seizure history. Subjects cannot be pregnant nor have indwelling metal or medical devices that are incompatible with TMS testing.
With the subject seated in a supportive chair, the subject's skin will be cleaned surrounding the first doral interoseus belly and dorsum of the hand. Next small surface electromyographic (EMG) electrodes will be attached at the muscle belly and tendon. A ground electrode will be placed on the dorsum of the hand or wrist.
Next, the threshold for TMS activation of the target muscle will be determined. To find the optimal position for activating the first dorsal interosseous muscle, we will use a 70-mm figure-eight TMS coil connected to a Magstim rapid magnetic stimulator. The coil will be handheld on the scalp over the approximate area of the primary motor cortex (M1) in the contralateral hemisphere to the recording electrode, and moved systematically to find the optimal position. Single-pulse magnetic stimuli will be delivered manually at approximately 0.1 Hz starting at an intensity of 50% of the stimulator maximum. This level will be adjusted systematically until the resting motor threshold is found, defined as the minimum intensity required to elicit a motor evoked potential (MEP) >50 µV peak-to-peak in at least 5 of 10 trials with the target muscle at rest. Various cortical excitability measures will be collected lasting approximately 20 minutes.
Finger tracking/training will be provided for 30 minutes under the supervision of the PI or Co-I. Subjects will wear a finger electrogoniometer at the index finger metacarpophalangeal (MP) joint. Subjects will use flexion/extension movements of the respective joint to track waveforms on a computer screen. The training would consist of 30 blocks of tracking trials. Each block will consist of 3 trials. The protocol parameters for different blocks will differ in waveform, amplitude, frequency, trial duration, and joint position. For example, a square wave would involve a different movement pattern execution as opposed to a triangular wave. The waveforms may also differ on the forearm position to create "stimulus-response compatible" or "stimulus-response incompatible" conditions. For example, a stimulus-response incompatible joint position would involve extending and flexing the joint (finger MP or elbow) in the horizontal plane to produce cursor movements in the vertical plane. All these factors challenge the individual's capabilities to problem solve to achieve optimum learning.
Following training and accuracy testing, cortical excitability measures will be collected again lasting approximately 20 minutes. Lastly, a saliva sample will be collected for genetic screening for brain derived neurotrophic factor (BDNF) polymorphism. We will collect approximately 2 ml (less than one-half teaspoon) of saliva by asking the subject to spit into a tube. It may take up to 30 minutes to provide a saliva sample, however, most people typically require less time (approximately 5 minutes).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Healthy adults
Key inclusion criteria (2 listed)
- 18-45 years
- no past history of psychiatric or neurologic disease.
Key exclusion criteria (3 listed)
- any neuromuscular disorder that impairs upper extremity motion or seizure history
- Pregnancy
- Indwelling metal or medical device that are incompatible with TMS testing.
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
Accuracy Index
Time frame: Day 1: posttest after training
A computer quantified tracking performance measure in each test. This is a calculation of accuracy by using the equation: AI = 100(P-E)/P. Where E is the root mean square (r.m.s.) error between the target line and the response line, and P is the size of the individual's target pattern, calculated as the r.m.s. difference between the sine wave and the midline separating the upper and lower phases of the sine wave. The magnitude of P is determined by the scale of the vertical axis, which is the subject's range of finger motion. Therefore, the AI is normalized to each subject's own range of motion and takes into account any differences between subjects in the excursion of the tracking target. The maximum possible score is 100%. Negative scores occur when the response line is so distant from the target that it falls on the opposite side of the midline.
2 secondary outcomes
Cortical Excitability
Time frame: Day 1: baseline
Cortical Excitability
Time frame: Day 1: posttest
Results and safety
The study was stopped early (reason given: Site unable to complete full data collection/protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2017.
Related trials for BDNF
RecruitingObservational study
Association Between Circulating BDNF Levels and Atrial Cardiomyopathy in Patients Undergoing Ablation for Persistent Atrial Fibrillation
Atrial Fibrillation (AF), Cardiac Arrhythmia
Active, not recruiting
Exercise Primed Stroke Rehabilitation
Stroke
Active, not recruiting
Exercise-Induced Lactate and Cognitive Function (ExLBC)
Cognition, Sodium Bicarbonate
Active, not recruitingPhase 2
Nightmare Deconstruction and Reprocessing vs. NightWare Wristband
Nightmare
Active, not recruiting
Impact of Intensive Computerized Cognitive Training
Acquired Brain Injury, Mild Cognitive Impairment
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.
Teresa J Kimberley, PhD, PT principal investigator
University of Minnesota
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 BDNF and Polymorphism, Genetic, run by University of Minnesota 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 2 inclusion and 3 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 12 May 2017. 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 (reason given: Site unable to complete full data collection/protocol). 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?
Accuracy Index (time frame: Day 1: posttest after training). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2017.