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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Behavioral: Sham rTMS; Other: Real rTMS; Behavioral: Supervised aerobic exercise

• Registration Number: NCT02741765
• Lead Sponsor: NYU Langone Health

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.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-03-31
• Study First Submitted QC: 2016-04-13
• Study First Posted: 2016-04-18
• Primary Completion: 2018-01-26
• Study Completion: 2018-01-26
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-12
• Last Update Posted: 2019-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Sham Group	Sham rTMS	Sham group will receive Sham rTMS+Aerobic Exercise
Group 2: Real Group	Supervised aerobic exercise	rTMS+Aerobic Exercise
Group 1: Sham Group	Supervised aerobic exercise	Sham group will receive Sham rTMS+Aerobic Exercise
Group 2: Real Group	Real rTMS	rTMS+Aerobic Exercise

Primary Outcome Measures

Name	Time	Method
Number of enrolled subjects that remain in study	2 Weeks
Recruitment Enrollment Numbers	2 Weeks

Secondary Outcome Measures

Name	Time	Method
Plasticity measured by TMS-PAS25 (LTP-like plasticity biomarker)	2 Weeks	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.
Freezing of Gait Questionnaire (FOG-Q)	2 Weeks
Parkinson's Disease Sleep Scale (PDSS)	2 Weeks
Parkinson's Disease Quality of Life (PDQ-39)	2 Weeks
Frontal Function Assessment (FAB)	2 Weeks
LASA Physical Activity Questionnaire (LAPAQ)	2 Weeks
Measurements of lymphocytes	2 Weeks
Measurements of TrkB	2 Weeks
Measurements of serum BDNF	2 Weeks
Timed Up and Go Test	2 Weeks

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States