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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
24
Subjects will participate in daily sessions of sham-rTMS
Subjects will participate in a combination of rTMS
New York University School of Medicine
New York, New York, United States
Recruitment Enrollment Numbers
Time frame: 2 Weeks
Number of enrolled subjects that remain in study
Time frame: 2 Weeks
Plasticity measured by TMS-PAS25 (LTP-like plasticity biomarker)
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.
Time frame: 2 Weeks
Measurements of lymphocytes
Time frame: 2 Weeks
Measurements of TrkB
Time frame: 2 Weeks
Measurements of serum BDNF
Time frame: 2 Weeks
Timed Up and Go Test
Time frame: 2 Weeks
Freezing of Gait Questionnaire (FOG-Q)
Time frame: 2 Weeks
Parkinson's Disease Quality of Life (PDQ-39)
Time frame: 2 Weeks
Parkinson's Disease Sleep Scale (PDSS)
Time frame: 2 Weeks
Frontal Function Assessment (FAB)
Time frame: 2 Weeks
LASA Physical Activity Questionnaire (LAPAQ)
Time frame: 2 Weeks
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