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

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ClinicalTrials.gov Identifier: NCT02741765
Recruitment Status : Completed
First Posted : April 18, 2016
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Behavioral: Sham rTMS Other: Real rTMS Behavioral: Supervised aerobic exercise Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Exercise and Transcranial Magnetic Stimulation: Increasing Brain Plasticity in Parkinson's Disease
Study Start Date : November 2015
Actual Primary Completion Date : January 26, 2018
Actual Study Completion Date : January 26, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Group 1: Sham Group
Sham group will receive Sham rTMS+Aerobic Exercise
 Behavioral: Sham rTMS
Subjects will participate in daily sessions of sham-rTMS

Behavioral: Supervised aerobic exercise
Experimental: Group 2: Real Group
rTMS+Aerobic Exercise
 Other: Real rTMS
Subjects will participate in a combination of rTMS

Behavioral: Supervised aerobic exercise


Outcome Measures
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Primary Outcome Measures :
  1. Recruitment Enrollment Numbers [ Time Frame: 2 Weeks ]
  2. Number of enrolled subjects that remain in study [ Time Frame: 2 Weeks ]

Secondary Outcome Measures :
  1. Plasticity measured by TMS-PAS25 (LTP-like plasticity biomarker) [ Time Frame: 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.

  2. Measurements of lymphocytes [ Time Frame: 2 Weeks ]
  3. Measurements of TrkB [ Time Frame: 2 Weeks ]
  4. Measurements of serum BDNF [ Time Frame: 2 Weeks ]
  5. Timed Up and Go Test [ Time Frame: 2 Weeks ]
  6. Freezing of Gait Questionnaire (FOG-Q) [ Time Frame: 2 Weeks ]
  7. Parkinson's Disease Quality of Life (PDQ-39) [ Time Frame: 2 Weeks ]
  8. Parkinson's Disease Sleep Scale (PDSS) [ Time Frame: 2 Weeks ]
  9. Frontal Function Assessment (FAB) [ Time Frame: 2 Weeks ]
  10. LASA Physical Activity Questionnaire (LAPAQ) [ Time Frame: 2 Weeks ]

Eligibility Criteria
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Ages Eligible for Study:   35 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02741765


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Milton Biagioni, MD New York University Medical School
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02741765    
Other Study ID Numbers: 15-00712
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by NYU Langone Health:
Transcranial Magnetic Stimulation
Exercise
Brain Plasticity
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases