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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02741765
• Other study ID #: 15-00712
• Status: Completed
• Phase: N/A
• Start date: November 2015
• Est. completion date: January 26, 2018

Study information

• Verified date: July 2019
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 26, 2018
• Est. primary completion date: January 26, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• Sham rTMS
Subjects will participate in daily sessions of sham-rTMS

Other:
• Real rTMS
Subjects will participate in a combination of rTMS

Behavioral:
• Supervised aerobic exercise

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recruitment Enrollment Numbers		2 Weeks
Primary	Number of enrolled subjects that remain in study		2 Weeks
Secondary	Plasticity measured by TMS-PAS25 (LTP-like plasticity biomarker)	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.	2 Weeks
Secondary	Measurements of lymphocytes		2 Weeks
Secondary	Measurements of TrkB		2 Weeks
Secondary	Measurements of serum BDNF		2 Weeks
Secondary	Timed Up and Go Test		2 Weeks
Secondary	Freezing of Gait Questionnaire (FOG-Q)		2 Weeks
Secondary	Parkinson's Disease Quality of Life (PDQ-39)		2 Weeks
Secondary	Parkinson's Disease Sleep Scale (PDSS)		2 Weeks
Secondary	Frontal Function Assessment (FAB)		2 Weeks
Secondary	LASA Physical Activity Questionnaire (LAPAQ)		2 Weeks