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

NYU Langone Health

Status: Completed

Conditions: Parkinson Disease

Treatments: Behavioral: Supervised aerobic exercise; Behavioral: Sham rTMS; Other: Real rTMS

Study type: Interventional

Funder types: Other

Identifiers

NCT02741765

15-00712

Details and patient eligibility

About

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.

Full 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.

Enrollment: 24 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 2 patient groups

Group 1: Sham Group

Active Comparator group

Description:

Sham group will receive Sham rTMS+Aerobic Exercise

Treatment:

Behavioral: Sham rTMS

Behavioral: Supervised aerobic exercise

Group 2: Real Group

Experimental group

Description:

rTMS+Aerobic Exercise

Treatment:

Other: Real rTMS

Behavioral: Supervised aerobic exercise