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

Completed · Not applicable · Has a placebo group

Conditions studied: Parkinson Disease

In brief

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.

Key facts

Study ID

NCT02741765

Run by

NYU Langone Health

People needed

24

Starts

2015-11-01

Expected to finish

2018-01-26

Last updated by the study team

2019-07-16

Who can join

Age: 35 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

Where it is running

• New York University School of Medicine — New York, New York, United States

Full record on ClinicalTrials.gov

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