Exercise and Transcranial Magnetic Stimulation: Increasing Brain Plasticity in Parkinson's Disease
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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
Primary Outcome Measures
- Recruitment Enrollment Numbers [2 Weeks]
- Number of enrolled subjects that remain in study [2 Weeks]
Secondary Outcome Measures
- 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.
- Measurements of lymphocytes [2 Weeks]
- Measurements of TrkB [2 Weeks]
- Measurements of serum BDNF [2 Weeks]
- Timed Up and Go Test [2 Weeks]
- Freezing of Gait Questionnaire (FOG-Q) [2 Weeks]
- Parkinson's Disease Quality of Life (PDQ-39) [2 Weeks]
- Parkinson's Disease Sleep Scale (PDSS) [2 Weeks]
- Frontal Function Assessment (FAB) [2 Weeks]
- LASA Physical Activity Questionnaire (LAPAQ) [2 Weeks]
Eligibility Criteria
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);
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Major or unstable medical illness;
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Pacemakers, neurostimulators, tattoos or metal foreign bodies in the head area (dental fillings are allowed);
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Untreated depression, or score of >20 on Beck Depression Inventory II;
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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;
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Diagnosis of dementia, or Montreal Cognitive Assessment (MoCA) <20;
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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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | New York University School of Medicine | New York | New York | United States | 10016 |
Sponsors and Collaborators
- NYU Langone Health
Investigators
- Principal Investigator: Milton Biagioni, MD, New York University Medical School
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 15-00712