Parkinson's DiseaseNCT00396942
Motor Skill Learning in People With Parkinson's Disease
An observational study of Parkinson's Disease, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will compare brain changes in people with Parkinson's disease with those of normal control subjects while they learn motor skills. People with Parkinson's disease sometimes have trouble learning new skills, but it is not known why. Read more about this study
- Who is it for?
- Ages 21 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2006to 3 Oct 2008
- 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 21 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Right-handed healthy volunteers (21-80 years old)
- Idiopathic PD confirmed by either the PI or an HMCS physician to establish the diagnosis and rule out any other neurologic condition that might affect cortical plasticity.
- Patients must fulfill categories 1 to 3 of the Modified Hoehn and Yahr Scale in the 'off-medication' state.
Who cannot join
- Subjects with a history of neurological disorder that might affect cortical plasticity including head injury with loss of consciousness and epilepsy, current use or a history of alcohol or drug abuse, psychiatric disorders requiring hospitalization, or prolonged treatment such as substance abuse addiction
- Subjects with dementia; mini mental state examination (MMSE) less than 25, frontal assessment battery (FAB) less than 13
- Subjects with other parkinsonian syndromes such as Lewy body disease, corticobasal degeneration, progressive supranuclear palsy, Binswanger disease and multiple system atrophy
- Subjects with marked tremor, dyskinesia or sensory disturbance
- Subject who have been treated with the subthalamic nucleus stimulation and pallidotomy
- Subjects who are unable to refrain from anti-parkinsonian medications for up to 15 hours on study days
Show all 13Show fewer
- Subjects with significant hearing loss
- The following exclusion criteria are due to the use of TMS:
- Subjects with cardiac pacemakers, intracardiac lines, implanted medication pump
- Subjects with blood vessel, cochlear, or eye implants
- Subjects with increased intracranial pressure as evaluated by clinical means
- Subjects with metal in the cranium
- Subjects with dental braces (but dental fillings are okay), metal fragments from occupational exposure or surgical clips in or near the brain
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
Official title: Evaluation of the Plasticity of the Primary Motor Cortex and Motor Learning in Parkinson's Disease
This study will compare brain changes in people with Parkinson's disease with those of normal control subjects while they learn motor skills. People with Parkinson's disease sometimes have trouble learning new skills, but it is not known why. This study will use repetitive transcranial magnetic stimulation (rTMS), nerve conduction studies, and electroencephaolography (EEG) to look for differences in the way the brain changes with learning in people with Parkinson's disease.
Healthy normal volunteers and people with Parkinson's disease who are between 21 and 80 years of age may be eligible for this study. Participants undergo the following procedures in five visits to the NIH Clinical Center:
Read more
Visit 1
Medical and neurological examination.
Visit 2
Motor training. Participants perform a pinching movement once every other second, timed to a metronome, during rTMS. For TMS, a wire coil is held on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in the muscles of the face, arm or leg. rTMS involves repeated magnetic pulses delivered in short bursts of impulses.
Visits 3 and 4
Brain physiology studies using rTMS, nerve conduction studies (electrical nerve stimulation) and EEG. A nerve at the subject's wrist is stimulated with electrical impulses to measure the speed with which nerves conduct electrical impulses and the strength of the connection between the nerve and the muscle. rTMS is performed for 20 minutes. The EEG measures the electrical activity of the brain (brain waves). For this test, electrodes (metal discs) are placed on the scalp with a conductive gel and the brain waves are recorded while the subject moves his or her thumb briskly for 20 minutes.
Visit 5
Subjects undergo rTMS for 20 minutes and have an EEG.
...
Read the detailed description
Objective
The aims of the present study are to:
- Clarify that the altered plasticity of the primary motor cortex (M1) in patients with Parkinson's disease (PD) is associated with impaired motor learning by using the paired associative stimulation (PAS) technique, which can enhance or inhibit the M1 excitability with paired stimulation to the contralateral peripheral nerve and cerebral cortex.
- Elucidate that the altered plasticity of the M1 in patients with PD goes together with impaired sensorimotor integration via the basal ganglia-thalamocortical loop.
Study population
12 right-handed patients with PD
12 right-handed age-matched healthy volunteers
Design
Patients and age-matched healthy volunteers will complete five different sessions: Visit 1: clinical screening; Visit 2: motor learning session; Visit 3 and 4: the paired associative stimulation (PAS) sessions; Visit 5: the control session.
During the motor learning session, subjects will be asked to perform metronome-paced pinch of their index finger and thumb.
During the PAS sessions, they will receive 20 minutes of paired stimulation to the contralateral peripheral nerve stimulation and transcranial magnetic stimulation (TMS) at the appropriate timing for producing changes of the M1 excitability.
During the control session, they will receive 20 minutes of repetitive TMS without the peripheral nerve stimulation.
Outcome measures
For the motor learning session:
- peak acceleration (MPA) of thumb movement
- maximal peak force (MPF) between the index finger and thumb
For the PAS and control sessions:
- peak-to-peak motor evoked potential (MEP) amplitude
- resting motor threshold
- afferent inhibition
- event related desynchronization (ERD) and event related synchronization (ERS)
- Conditions
- Parkinson's Disease
- Keywords
- Electroencephalogram (EEG), Nerve Conduction Study, Transcranial Magnetic Stimulation (TMS), Motor Evoked Potential, Parkinson Disease, PD, Healthy Volunteer, HV
- Medical subject headings
- Parkinson Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2006 (estimated)
- Study start2 Nov 2006
- Study completion3 Oct 2008
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.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- 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
- Enrolment
- 24 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00396942
- Sponsor's protocol ID
- 070020
- Other IDs
- 07-N-0020
- Status last verified
- 3 Oct 2008
- First submitted
- 7 Nov 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Bliss TV, Lomo T. Long-lasting potentiation of synaptic transmission in the dentate area of the anaesthetized rabbit following stimulation of the perforant path. J Physiol. 1973 Jul;232(2):331-56. doi: 10.1113/jphysiol.1973.sp010273.
PubMed 4727084Buonomano DV, Merzenich MM. Cortical plasticity: from synapses to maps. Annu Rev Neurosci. 1998;21:149-86. doi: 10.1146/annurev.neuro.21.1.149.
PubMed 9530495Dan Y, Poo MM. Spike timing-dependent plasticity of neural circuits. Neuron. 2004 Sep 30;44(1):23-30. doi: 10.1016/j.neuron.2004.09.007.
PubMed 15450157
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Plasticity of the Primary Motor Cortex and Motor Learning in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00396942
- Acronym / sponsor ID
- 070020
- Conditions
- Parkinson's Disease
- Keywords
- Electroencephalogram (EEG), Nerve Conduction Study, Transcranial Magnetic Stimulation (TMS), Motor Evoked Potential, Parkinson Disease, PD, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 2 Nov 2006
- Study completion
- 3 Oct 2008
- First posted
- 8 Nov 2006 (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.
This study will compare brain changes in people with Parkinson's disease with those of normal control subjects while they learn motor skills. People with Parkinson's disease sometimes have trouble learning new skills, but it is not known why. This study will use repetitive transcranial magnetic stimulation (rTMS), nerve conduction studies, and electroencephaolography (EEG) to look for differences in the way the brain changes with learning in people with Parkinson's disease.
Healthy normal volunteers and people with Parkinson's disease who are between 21 and 80 years of age may be eligible for this study. Participants undergo the following procedures in five visits to the NIH Clinical Center:
Visit 1
Medical and neurological examination.
Visit 2
Motor training. Participants perform a pinching movement once every other second, timed to a metronome, during rTMS. For TMS, a wire coil is held on the subject's scalp. A brief electrical current is passed through the coil, creating a magnetic pulse that stimulates the brain. The subject hears a click and may feel a pulling sensation on the skin under the coil. There may be a twitch in the muscles of the face, arm or leg. rTMS involves repeated magnetic pulses delivered in short bursts of impulses.
Visits 3 and 4
Brain physiology studies using rTMS, nerve conduction studies (electrical nerve stimulation) and EEG. A nerve at the subject's wrist is stimulated with electrical impulses to measure the speed with which nerves conduct electrical impulses and the strength of the connection between the nerve and the muscle. rTMS is performed for 20 minutes. The EEG measures the electrical activity of the brain (brain waves). For this test, electrodes (metal discs) are placed on the scalp with a conductive gel and the brain waves are recorded while the subject moves his or her thumb briskly for 20 minutes.
Visit 5
Subjects undergo rTMS for 20 minutes and have an EEG.
...
Detailed description
Objective
The aims of the present study are to:
- Clarify that the altered plasticity of the primary motor cortex (M1) in patients with Parkinson's disease (PD) is associated with impaired motor learning by using the paired associative stimulation (PAS) technique, which can enhance or inhibit the M1 excitability with paired stimulation to the contralateral peripheral nerve and cerebral cortex.
- Elucidate that the altered plasticity of the M1 in patients with PD goes together with impaired sensorimotor integration via the basal ganglia-thalamocortical loop.
Study population
12 right-handed patients with PD
12 right-handed age-matched healthy volunteers
Design
Patients and age-matched healthy volunteers will complete five different sessions: Visit 1: clinical screening; Visit 2: motor learning session; Visit 3 and 4: the paired associative stimulation (PAS) sessions; Visit 5: the control session.
During the motor learning session, subjects will be asked to perform metronome-paced pinch of their index finger and thumb.
During the PAS sessions, they will receive 20 minutes of paired stimulation to the contralateral peripheral nerve stimulation and transcranial magnetic stimulation (TMS) at the appropriate timing for producing changes of the M1 excitability.
During the control session, they will receive 20 minutes of repetitive TMS without the peripheral nerve stimulation.
Outcome measures
For the motor learning session:
- peak acceleration (MPA) of thumb movement
- maximal peak force (MPF) between the index finger and thumb
For the PAS and control sessions:
- peak-to-peak motor evoked potential (MEP) amplitude
- resting motor threshold
- afferent inhibition
- event related desynchronization (ERD) and event related synchronization (ERS)
Study design
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Right-handed healthy volunteers (21-80 years old)
- Idiopathic PD confirmed by either the PI or an HMCS physician to establish the diagnosis and rule out any other neurologic condition that might affect cortical plasticity.
- Patients must fulfill categories 1 to 3 of the Modified Hoehn and Yahr Scale in the 'off-medication' state.
Key exclusion criteria (13 listed)
- Subjects with a history of neurological disorder that might affect cortical plasticity including head injury with loss of consciousness and epilepsy, current use or a history of alcohol or drug abuse, psychiatric disorders requiring hospitalization, or prolonged treatment such as substance abuse addiction
- Subjects with dementia; mini mental state examination (MMSE) less than 25, frontal assessment battery (FAB) less than 13
- Subjects with other parkinsonian syndromes such as Lewy body disease, corticobasal degeneration, progressive supranuclear palsy, Binswanger disease and multiple system atrophy
- Subjects with marked tremor, dyskinesia or sensory disturbance
- Subject who have been treated with the subthalamic nucleus stimulation and pallidotomy
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 4727084Bliss TV, Lomo T. Long-lasting potentiation of synaptic transmission in the dentate area of the anaesthetized rabbit following stimulation of the perforant path. J Physiol. 1973 Jul;232(2):331-56. doi: 10.1113/jphysiol.1973.sp010273.
- Background: PubMed 9530495Buonomano DV, Merzenich MM. Cortical plasticity: from synapses to maps. Annu Rev Neurosci. 1998;21:149-86. doi: 10.1146/annurev.neuro.21.1.149.
- Background: PubMed 15450157Dan Y, Poo MM. Spike timing-dependent plasticity of neural circuits. Neuron. 2004 Sep 30;44(1):23-30. doi: 10.1016/j.neuron.2004.09.007.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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, 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 13 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: finished, as of the sponsor's last update on 2 Jul 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00396942, 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 2 Jul 2017.