Exercise and Transcranial Magnetic Stimulation: Increasing Brain Plasticity in Parkinson's Disease



Status:Completed
Conditions:Parkinsons Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:35 - 85
Updated:5/5/2018
Start Date:November 2015
End Date:January 26, 2018

Use our guide to learn which trials are right for you!

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.

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
We found this trial at
1
site
550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Alessandro Di Rocco, MD
New York University School of Medicine NYU School of Medicine has a proud history that...
?
mi
from
New York, NY
Click here to add this to my saved trials