Parkinson Disease
Conditions
Keywords
Transcranial Magnetic Stimulation, Exercise, Brain Plasticity
Brief summary
This is a feasibility and exploratory study consisting of two parts: first, a cross-sectional (one-time) biomarker measurement comparing BDNF-TrkB (Brain-derived neurotrophic factor (BDNF) and its receptor, TrkB,) signaling and cortical plasticity in patients diagnosed with Parkinson's Disease (PD) vs. healthy controls matched by age. Second, a prospective, randomized, double blind trial of Transcranial Magnetic Stimulation (TMS) MAGSTIM Rapid2 Therapy System (TMS) (real or Sham) and aerobic exercise. This exploratory feasibility study will look at BDNF-TrkB signaling and cortical plasticity.
Detailed description
Twenty-four PD patients (n=24) will be randomly assigned to receive one of two interventions for a duration of two weeks. In Group 1, subjects will participate in daily sessions of sham-rTMS followed by supervised aerobic exercise (Sham rTMS+Aerobic); in Group 2, subjects will participate in a combination of rTMS and supervised aerobic exercise (Real rTMS+Aerobic). Serum BDNF-TrkB signaling in lymphocytes and TMS-based electrophysiological measures of LTP-like plasticity will be measured. A comparison of such measures in a group of patients with PD and in a group of age-matched controls (n=12) will be analyzed to establish the effect of the disease on indices of plasticity.
Interventions
BEHAVIORALSham rTMS
Subjects will participate in daily sessions of sham-rTMS
OTHERReal rTMS
Subjects will participate in a combination of rTMS
BEHAVIORALSupervised aerobic exercise
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
* Diagnosis of PD according to the UK Brain Bank Criteria, confirmed by a neurologist with expertise in movement disorders; * Hoehn and Yahr stage II to III; * On a stable medication regimen since at least 2 weeks prior the enrolment in the study and, in the view of the treating neurologist, unlikely to require medication adjustments in the following 3-6 months. Inclusion Criteria (Healthy Controls) * Male or Female; aged 35-85
Exclusion criteria
(Healthy Controls) * History of seizure disorder, including febrile seizures; * Neurological disorder including PD, stroke, traumatic brain injury, fainting spells or syncope of unknown cause(s); * Major or unstable medical illness; * Pacemakers, neurostimulators, tattoos or metal foreign bodies in the head area (dental fillings are allowed); * Untreated depression, or score of \>20 on Beck Depression Inventory II; * Taking any of the following medications within the six weeks prior to the start of the study: imipramine, amitriptyline, doxepin, nortriptyline, maprotiline, chlorpromazine, clozapine, foscarnet, ganciclovir, ritonavir, theophylline, calcium channel blockers, beta blockers, tadalafil, vardenafil, avanafil, and sildenafil; * Diagnosis of dementia, or Montreal Cognitive Assessment (MoCA) \<20; * Any clinically significant abnormality on vital signs * Cardiopulmonary limitations: untreated high blood pressure, history of heart insufficiency (class II-III), coronary vascular disease, angina, arrhythmia, dyspnea on exertion and asthma
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recruitment Enrollment Numbers | 2 Weeks |
| Number of enrolled subjects that remain in study | 2 Weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measurements of TrkB | 2 Weeks | — |
| Measurements of serum BDNF | 2 Weeks | — |
| Timed Up and Go Test | 2 Weeks | — |
| Freezing of Gait Questionnaire (FOG-Q) | 2 Weeks | — |
| Plasticity measured by TMS-PAS25 (LTP-like plasticity biomarker) | 2 Weeks | A paired associative paradigm at 25 ms (TMS-PAS-25) to quantify cortical LTP in M1 motor cortex will be used. As well as a repetitive biphasic magnetic stimulator (Magstim Rapid2 stimulator -Magstim Co., Whitland, U.K.) with a Figure of eight coil (outer diameters: 9 cm) and apply standard protocol for LTP-like measurements. |
| Parkinson's Disease Sleep Scale (PDSS) | 2 Weeks | — |
| Frontal Function Assessment (FAB) | 2 Weeks | — |
| LASA Physical Activity Questionnaire (LAPAQ) | 2 Weeks | — |
| Parkinson's Disease Quality of Life (PDQ-39) | 2 Weeks | — |
| Measurements of lymphocytes | 2 Weeks | — |
Countries
United States
Outcome results
None listed