Back to resultsExercise and Transcranial Magnetic Stimulation: Increasing Brain Plasticity in Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sham rTMS
Real rTMS
Supervised aerobic exercise
Sponsored by
About this trial
This is an interventional supportive care trial for Parkinson Disease focused on measuring Transcranial Magnetic Stimulation, Exercise, Brain Plasticity
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.
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group 1: Sham Group
Group 2: Real Group
Arm Description
Sham group will receive Sham rTMS+Aerobic Exercise
rTMS+Aerobic Exercise
Outcomes
Primary Outcome Measures
Recruitment Enrollment Numbers
Number of enrolled subjects that remain in study
Secondary Outcome Measures
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.
Measurements of lymphocytes
Measurements of TrkB
Measurements of serum BDNF
Timed Up and Go Test
Freezing of Gait Questionnaire (FOG-Q)
Parkinson's Disease Quality of Life (PDQ-39)
Parkinson's Disease Sleep Scale (PDSS)
Frontal Function Assessment (FAB)
LASA Physical Activity Questionnaire (LAPAQ)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02741765
Brief Title
Exercise and Transcranial Magnetic Stimulation: Increasing Brain Plasticity in Parkinson's Disease
Official Title
Exercise and Transcranial Magnetic Stimulation: Increasing Brain Plasticity in Parkinson's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (undefined)
Primary Completion Date
January 26, 2018 (Actual)
Study Completion Date
January 26, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Transcranial Magnetic Stimulation, Exercise, Brain Plasticity
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1: Sham Group
Arm Type
Active Comparator
Arm Description
Sham group will receive Sham rTMS+Aerobic Exercise
Arm Title
Group 2: Real Group
Arm Type
Experimental
Arm Description
rTMS+Aerobic Exercise
Intervention Type
Behavioral
Intervention Name(s)
Sham rTMS
Intervention Description
Subjects will participate in daily sessions of sham-rTMS
Intervention Type
Other
Intervention Name(s)
Real rTMS
Intervention Description
Subjects will participate in a combination of rTMS
Intervention Type
Behavioral
Intervention Name(s)
Supervised aerobic exercise
Primary Outcome Measure Information:
Title
Recruitment Enrollment Numbers
Time Frame
2 Weeks
Title
Number of enrolled subjects that remain in study
Time Frame
2 Weeks
Secondary Outcome Measure Information:
Title
Plasticity measured by TMS-PAS25 (LTP-like plasticity biomarker)
Description
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.
Time Frame
2 Weeks
Title
Measurements of lymphocytes
Time Frame
2 Weeks
Title
Measurements of TrkB
Time Frame
2 Weeks
Title
Measurements of serum BDNF
Time Frame
2 Weeks
Title
Timed Up and Go Test
Time Frame
2 Weeks
Title
Freezing of Gait Questionnaire (FOG-Q)
Time Frame
2 Weeks
Title
Parkinson's Disease Quality of Life (PDQ-39)
Time Frame
2 Weeks
Title
Parkinson's Disease Sleep Scale (PDSS)
Time Frame
2 Weeks
Title
Frontal Function Assessment (FAB)
Time Frame
2 Weeks
Title
LASA Physical Activity Questionnaire (LAPAQ)
Time Frame
2 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Milton Biagioni, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Exercise and Transcranial Magnetic Stimulation: Increasing Brain Plasticity in Parkinson's Disease
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