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

NCT ID: NCT02741765

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-11-30
• Study Completion Date: 2018-01-26

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Group 1: Sham Group

Sham group will receive Sham rTMS+Aerobic Exercise

Group Type: ACTIVE_COMPARATOR

Sham rTMS

Intervention Type: BEHAVIORAL

Subjects will participate in daily sessions of sham-rTMS

Supervised aerobic exercise

Intervention Type: BEHAVIORAL

Group 2: Real Group

rTMS+Aerobic Exercise

Group Type: EXPERIMENTAL

Real rTMS

Intervention Type: OTHER

Subjects will participate in a combination of rTMS

Supervised aerobic exercise

Intervention Type: BEHAVIORAL

Interventions

Sham rTMS

Subjects will participate in daily sessions of sham-rTMS

Intervention Type: BEHAVIORAL

Real rTMS

Subjects will participate in a combination of rTMS

Intervention Type: OTHER

Supervised aerobic exercise

Intervention Type: BEHAVIORAL

Eligibility 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.

• Male or Female; aged 35-85

Exclusion Criteria

• 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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Milton Biagioni, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

15-00712

Identifier Type: -

Identifier Source: org_study_id