Cerebral PalsyNCT02839733
Dopamine and Motor Learning in Cerebral Palsy
An observational study of Cerebral Palsy, run by National Institutes of Health Clinical Center (CC) at 1 site in United States.
Trial summary
Background: Cerebral palsy (CP) is the most common childhood motor disability. The neurotransmitter dopamine (DA) is important in cognition and emotions/behavior. DA may also be important in motor skill learning. Genes that relate to DA function may affect a person s ability to learn new cognitive or motor skills. Read more about this study
- Who is it for?
- Ages 5 to 25 years
- Conditions the study is for
- Cerebral Palsy
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2017to 12 Nov 2024
- 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 5 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: A maximum of 120 ambulatory children and young adults with and without CP (ages 5-25 inclusive) will be enrolled in this protocol.
Who may be able to join
- For all subjects:
- Ages 5-25 inclusive
- Able to follow the study protocol
- Able to attend or perform the training sessions as scheduled
- Additional criteria for subjects with CP:
- Diagnosis of cerebral palsy
- Gross Motor Functional Classification Scale Level I-II (able to walk at least 10 meters without an assistive device)
Who cannot join
- For all subjects:
- 1. Presence of an injury or other medical condition (besides CP) that would affect motor function or the ability to perform the motor training program.
- Additional criteria for subjects with CP:
- Less than 6 months after major surgery to their legs
- Currently taking levodopa, trihexyphenidyl, methylphenidate or baclofen since these may affect dopamine transmission or neuroplasticity.
- Additional criteria for those with CP who choose to have an MRI:
Show all 12Show fewer
- 1. Have any of the following contraindications to having an MRI scan:
- Pregnancy
- A ventriculo-peritoneal shunt
- Have claustrophobia and not comfortable in small enclosed spaces
- Have metal that would make an MRI scan unsafe such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion devise, cochlear or ear implant, transdermal medication patch (nitroglycerine), any metallic implants or objects, body piercing that cannot be removed, bone or joint pin, screw, nail, plate, wire sutures or surgical staples, shunts, cerebral aneurysms clips, shrapnel or other metal embedded (such as from war wounds or accidents or previous work in metal fields or machines that may have left any metallic fragments in or near your eyes).
- Excessive startle reaction to or fear of loud noises
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Background:
Cerebral palsy (CP) is the most common childhood motor disability. The neurotransmitter dopamine (DA) is important in cognition and emotions/behavior. DA may also be important in motor skill learning. Genes that relate to DA function may affect a person s ability to learn new cognitive or motor skills. Some children with CP can learn motor skills easily while others have trouble. Researchers want to find out if DA gene variations cause some of this variability.
Read more
Objectives:
To learn more about how DA and its related genes affect motor and cognitive learning in people with and without CP.
Eligibility:
People ages 5 25 with and without CP who can:
Follow the protocol
Attend and perform the training sessions
Design:
Participants will be screened with:
Medical history
Physical exam
Blood draw for genetic tests
The study has 2 parts. Participants with CP can join both. Those without can join only Part 1.
All participants will have a baseline assessment: short motor skills test and blood draw.
Part 1:
Two 10-session training programs over 2 weeks. Cognitive training will be 2 sessions at the clinic, 8 at home. Participants will perform memory tasks on a computer. All 10 motor training sessions are at the clinic. Participants will step on lines in a virtual reality environment.
Part 2:
Two lab training sessions at least 1 week apart. Participants will perform tasks on a
computer.
Participants with CP may have a brain MRI at 1 visit. They will lie on a table that slides into a machine that takes pictures. They will be in the scanner about 45 minutes. They may have a
Read the detailed description
Objective
The broad objective of this study is to determine the relationship between variations in genes related to dopamine (DA) neurotransmission in areas of the brain associated with motor leaning (e.g. DRD1, DRD2, DRD3, COMT, DAT) and/or to activity-dependent brain plasticity (e.g. BDNF) and differences in motor learning rates and cognitive processing abilities in persons with and without cerebral palsy (CP). We hypothesize that individual genetic differences will be related to the ability to learn new motor and cognitive skills and may thus provide a potential explanation for the often reported response variability to rehabilitative therapies seen in CP. We will also explore whether motor and cognitive learning abilities are correlated within individuals which could suggest similar underlying neural mechanisms. Finally we would like to evaluate the effect of rewards on procedural learning in those with and without CP, to preliminarily assess how behavioral manipulations of the DA system may affect learning.
Study Population: A maximum of 120 ambulatory children and young adults with and without CP (ages 5-25 inclusive) will be enrolled in this protocol.
Design: This protocol will consist of two separate but related studies: Study #1 is an observational trial whereby subjects with and without CP will participate in two different training paradigms, 10 sessions each, one that involves learning novel working memory tasks and one that involves motor skill learning in the lower extremities, adapted from the horizontal ladder task utilized in rodent studies. All will have blood draws for genetic analyses at baseline, the results of which will be related to changes in performance (learning) per task after training.
Study #2 will be a within-subjects evaluation in CP and controls on the effects of reward (versus no-reward) during learning, which is presumed to increase dopamine transmission. Mean and individual responses to reward-based learning will be assessed and related to genetic variations in dopamine transmission.
For subjects with CP, we would like to obtain brain MRI but this is optional and if they are unable or unwilling to do this portion, they can still participate in this protocol.
Outcome Measures: Primary outcomes are changes in performance (learning) on each task after training which will be related to presence or absence of polymorphisms that have been associated with brain plasticity or with deficits in working memory and/or motor learning. Individual responses to rewards will also be related to variations related to high versus low dopamine transmission in the brain.
- Conditions
- Cerebral Palsy
- Keywords
- Brain Imaging, Adult, DNA Testing, Children, Natural History
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cerebral Palsy | Children and young adults with Cerebral Palsy. | |
| Healthy Volunteer | Children and young adults healthy volunteer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Learning (specific measures vary by task)
There will be two tasks : 1 a motor task which involves walking across a horizontal ladder. 2. Computer base tasks targeting working memory and procedural learning
Measured: measure of learning of each training task across the entire training period
Genetic testing (for dopamine and activity-related genes)
COMT, BDNF, DAT, and DRD1, DRD2, DRD3
Measured: genetic analyses of individual variations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2016 (estimated)
- Study start21 Jun 2017
- Primary completion10 Dec 2021
- Study completion12 Nov 2024
Why it stopped: Study closed due to change in personnel.
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 Cerebral PalsyStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institutes of Health Clinical Center (CC)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Diane L Damiano, Ph.D., Principal investigator, National Institutes of Health Clinical Center (CC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02839733
- Sponsor's protocol ID
- 160149
- Other IDs
- 16-CC-0149
- Status last verified
- Nov 2024
- First submitted
- 19 Jul 2016
- Last updated
- 19 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Only data without participants protected health information or identifiers will be shared.
Publications
Qian Y, Chen M, Forssberg H, Diaz Heijtz R. Genetic variation in dopamine-related gene expression influences motor skill learning in mice. Genes Brain Behav. 2013 Aug;12(6):604-14. doi: 10.1111/gbb.12062. Epub 2013 Jul 17.
PubMed 23819855Pearson-Fuhrhop KM, Minton B, Acevedo D, Shahbaba B, Cramer SC. Genetic variation in the human brain dopamine system influences motor learning and its modulation by L-Dopa. PLoS One. 2013 Apr 17;8(4):e61197. doi: 10.1371/journal.pone.0061197. Print 2013.
PubMed 23613810Molina-Luna K, Pekanovic A, Rohrich S, Hertler B, Schubring-Giese M, Rioult-Pedotti MS, Luft AR. Dopamine in motor cortex is necessary for skill learning and synaptic plasticity. PLoS One. 2009 Sep 17;4(9):e7082. doi: 10.1371/journal.pone.0007082.
PubMed 19759902
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dopamine and Motor Learning in Cerebral Palsy
- ClinicalTrials.gov ID
- NCT02839733
- Acronym / sponsor ID
- 160149
- Conditions
- Cerebral Palsy
- Keywords
- Brain Imaging, Adult, DNA Testing, Children, Natural History
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study closed due to change in personnel.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Institutes of Health Clinical Center (CC)US National Institutes of Health
- Study start
- 21 Jun 2017 (actual)
- Primary completion
- 10 Dec 2021 (actual)
- Study completion
- 12 Nov 2024 (actual)
- First posted
- 21 Jul 2016 (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:
Cerebral palsy (CP) is the most common childhood motor disability. The neurotransmitter dopamine (DA) is important in cognition and emotions/behavior. DA may also be important in motor skill learning. Genes that relate to DA function may affect a person s ability to learn new cognitive or motor skills. Some children with CP can learn motor skills easily while others have trouble. Researchers want to find out if DA gene variations cause some of this variability.
Objectives:
To learn more about how DA and its related genes affect motor and cognitive learning in people with and without CP.
Eligibility:
People ages 5 25 with and without CP who can:
Follow the protocol
Attend and perform the training sessions
Design:
Participants will be screened with:
Medical history
Physical exam
Blood draw for genetic tests
The study has 2 parts. Participants with CP can join both. Those without can join only Part 1.
All participants will have a baseline assessment: short motor skills test and blood draw.
Part 1:
Two 10-session training programs over 2 weeks. Cognitive training will be 2 sessions at the clinic, 8 at home. Participants will perform memory tasks on a computer. All 10 motor training sessions are at the clinic. Participants will step on lines in a virtual reality environment.
Part 2:
Two lab training sessions at least 1 week apart. Participants will perform tasks on a
computer.
Participants with CP may have a brain MRI at 1 visit. They will lie on a table that slides into a machine that takes pictures. They will be in the scanner about 45 minutes. They may have a
Detailed description
Objective
The broad objective of this study is to determine the relationship between variations in genes related to dopamine (DA) neurotransmission in areas of the brain associated with motor leaning (e.g. DRD1, DRD2, DRD3, COMT, DAT) and/or to activity-dependent brain plasticity (e.g. BDNF) and differences in motor learning rates and cognitive processing abilities in persons with and without cerebral palsy (CP). We hypothesize that individual genetic differences will be related to the ability to learn new motor and cognitive skills and may thus provide a potential explanation for the often reported response variability to rehabilitative therapies seen in CP. We will also explore whether motor and cognitive learning abilities are correlated within individuals which could suggest similar underlying neural mechanisms. Finally we would like to evaluate the effect of rewards on procedural learning in those with and without CP, to preliminarily assess how behavioral manipulations of the DA system may affect learning.
Study Population: A maximum of 120 ambulatory children and young adults with and without CP (ages 5-25 inclusive) will be enrolled in this protocol.
Design: This protocol will consist of two separate but related studies: Study #1 is an observational trial whereby subjects with and without CP will participate in two different training paradigms, 10 sessions each, one that involves learning novel working memory tasks and one that involves motor skill learning in the lower extremities, adapted from the horizontal ladder task utilized in rodent studies. All will have blood draws for genetic analyses at baseline, the results of which will be related to changes in performance (learning) per task after training.
Study #2 will be a within-subjects evaluation in CP and controls on the effects of reward (versus no-reward) during learning, which is presumed to increase dopamine transmission. Mean and individual responses to reward-based learning will be assessed and related to genetic variations in dopamine transmission.
For subjects with CP, we would like to obtain brain MRI but this is optional and if they are unable or unwilling to do this portion, they can still participate in this protocol.
Outcome Measures: Primary outcomes are changes in performance (learning) on each task after training which will be related to presence or absence of polymorphisms that have been associated with brain plasticity or with deficits in working memory and/or motor learning. Individual responses to rewards will also be related to variations related to high versus low dopamine transmission in the brain.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cerebral Palsy | – | –Children and young adults with Cerebral Palsy. |
| Healthy Volunteer | – | –Children and young adults healthy volunteer |
Who may qualify
- Ages
- 5 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- A maximum of 120 ambulatory children and young adults with and without CP (ages 5-25 inclusive) will be enrolled in this protocol.
Key inclusion criteria (7 listed)
- Ages 5-25 inclusive
- Able to follow the study protocol
- Able to attend or perform the training sessions as scheduled
- Diagnosis of cerebral palsy
- Gross Motor Functional Classification Scale Level I-II (able to walk at least 10 meters without an assistive device)
Key exclusion criteria (12 listed)
- 1. Presence of an injury or other medical condition (besides CP) that would affect motor function or the ability to perform the motor training program.
- Less than 6 months after major surgery to their legs
- Currently taking levodopa, trihexyphenidyl, methylphenidate or baclofen since these may affect dopamine transmission or neuroplasticity.
- Pregnancy
- A ventriculo-peritoneal shunt
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
Learning (specific measures vary by task)
Time frame: measure of learning of each training task across the entire training period
There will be two tasks : 1 a motor task which involves walking across a horizontal ladder. 2. Computer base tasks targeting working memory and procedural learning
Genetic testing (for dopamine and activity-related genes)
Time frame: genetic analyses of individual variations
COMT, BDNF, DAT, and DRD1, DRD2, DRD3
Results and safety
The study was stopped early (reason given: Study closed due to change in personnel.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2024.
- Background: PubMed 23819855Qian Y, Chen M, Forssberg H, Diaz Heijtz R. Genetic variation in dopamine-related gene expression influences motor skill learning in mice. Genes Brain Behav. 2013 Aug;12(6):604-14. doi: 10.1111/gbb.12062. Epub 2013 Jul 17.
- Background: PubMed 23613810Pearson-Fuhrhop KM, Minton B, Acevedo D, Shahbaba B, Cramer SC. Genetic variation in the human brain dopamine system influences motor learning and its modulation by L-Dopa. PLoS One. 2013 Apr 17;8(4):e61197. doi: 10.1371/journal.pone.0061197. Print 2013.
- Background: PubMed 19759902Molina-Luna K, Pekanovic A, Rohrich S, Hertler B, Schubring-Giese M, Rioult-Pedotti MS, Luft AR. Dopamine in motor cortex is necessary for skill learning and synaptic plasticity. PLoS One. 2009 Sep 17;4(9):e7082. doi: 10.1371/journal.pone.0007082.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Only data without participants protected health information or identifiers will be shared.
Related trials for Cerebral Palsy
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
Not yet recruiting
Ayres Sensory Integration Intervention for Children With Cerebral Palsy
Cerebral Palsy (CP)
Recruiting
Combined Popliteal and Adductor Canal Blocks for Postoperative Analgesia in Children With Cerebral Palsy
Cerebral Palsy, Postoperative Pain
Recruiting
Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation
Cerebral Palsy
Recruiting
Short-Term Effects of Manual Therapy Prior to Neuromotor Therapy in Children With Cerebral Palsy
Cerebral Palsy (CP), Unilateral Spastic Cerebral Palsy
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.
Diane L Damiano, Ph.D. principal investigator
National Institutes of Health Clinical Center (CC)
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 Cerebral Palsy, run by National Institutes of Health Clinical Center (CC) 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 7 inclusion and 12 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 19 Nov 2024. 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: Study closed due to change in personnel.). 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?
Learning (specific measures vary by task) (time frame: measure of learning of each training task across the entire training period). The study lists 2 primary outcomes in all. 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 NCT02839733, 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 19 Nov 2024.