Parkinson's Disease Clinical Trial
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:
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.
Objective
The aims of the present study are to:
1. 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.
2. 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)
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02915848 -
Long-term Stability of LFP Recorded From the STN and the Effects of DBS
|
||
Recruiting |
NCT03648905 -
Clinical Laboratory Evaluation of Chronic Autonomic Failure
|
||
Terminated |
NCT02688465 -
Effect of an Apomorphine Pump on the Quality of Sleep in Parkinson's Disease Patients (POMPRENELLE).
|
Phase 4 | |
Completed |
NCT05040048 -
Taxonomy of Neurodegenerative Diseases : Observational Study in Alzheimer's Disease and Parkinson's Disease
|
||
Active, not recruiting |
NCT04006210 -
Efficacy, Safety and Tolerability Study of ND0612 vs. Oral Immediate Release Levodopa/Carbidopa (IR-LD/CD) in Subjects With Parkinson's Disease Experiencing Motor Fluctuations
|
Phase 3 | |
Completed |
NCT02562768 -
A Study of LY3154207 in Healthy Participants and Participants With Parkinson's Disease
|
Phase 1 | |
Completed |
NCT00105521 -
Sarizotan in Participants With Parkinson's Disease Suffering From Treatment Associated Dyskinesia
|
Phase 3 | |
Completed |
NCT00105508 -
Sarizotan HC1 in Patients With Parkinson's Disease Suffering From Treatment-associated Dyskinesia
|
Phase 3 | |
Recruiting |
NCT06002581 -
Repetitive Transcranial Magnetic Stimulation(rTMS) Regulating Slow-wave to Delay the Progression of Parkinson's Disease
|
N/A | |
Completed |
NCT02236260 -
Evaluation of the Benefit Provided by Acupuncture During a Surgery of Deep Brain Stimulation
|
N/A | |
Completed |
NCT00529724 -
Body Weight Gain, Parkinson, Subthalamic Stimulation
|
Phase 2 | |
Active, not recruiting |
NCT05699460 -
Pre-Gene Therapy Study in Parkinson's Disease and Multiple System Atrophy
|
||
Completed |
NCT03703570 -
A Study of KW-6356 in Patients With Parkinson's Disease on Treatment With Levodopa-containing Preparations
|
Phase 2 | |
Completed |
NCT03462680 -
GPR109A and Parkinson's Disease: Role of Niacin in Outcome Measures
|
N/A | |
Completed |
NCT02837172 -
Diagnosis of PD and PD Progression Using DWI
|
||
Not yet recruiting |
NCT04046276 -
Intensity of Aerobic Training and Neuroprotection in Parkinson's Disease
|
N/A | |
Recruiting |
NCT02952391 -
Assessing Cholinergic Innervation in Parkinson's Disease Using the PET Imaging Marker [18F]Fluoroethoxybenzovesamicol
|
N/A | |
Active, not recruiting |
NCT02937324 -
The CloudUPDRS Smartphone Software in Parkinson's Study.
|
N/A | |
Terminated |
NCT02924194 -
Deep Brain Stimulation of the nbM to Treat Mild Cognitive Impairment in Parkinson's Disease
|
N/A | |
Completed |
NCT02939391 -
A Study of KW-6356 in Subjects With Early Parkinson's Disease
|
Phase 2 |