Clinical trial NCT02741765: 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
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Transcranial Magnetic Stimulation
Exercise
Brain Plasticity
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-18
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Recruitment Enrollment Numbers
timeFrame: 2 Weeks
measure: Number of enrolled subjects that remain in study
timeFrame: 2 Weeks
Secondary outcomes:
measure: Plasticity measured by TMS-PAS25 (LTP-like plasticity biomarker)
timeFrame: 2 Weeks
measure: Measurements of lymphocytes
timeFrame: 2 Weeks
measure: Measurements of TrkB
timeFrame: 2 Weeks
measure: Measurements of serum BDNF
timeFrame: 2 Weeks
measure: Timed Up and Go Test
timeFrame: 2 Weeks
measure: Freezing of Gait Questionnaire (FOG-Q)
timeFrame: 2 Weeks
measure: Parkinson's Disease Quality of Life (PDQ-39)
timeFrame: 2 Weeks
measure: Parkinson's Disease Sleep Scale (PDSS)
timeFrame: 2 Weeks
measure: Frontal Function Assessment (FAB)
timeFrame: 2 Weeks
measure: LASA Physical Activity Questionnaire (LAPAQ)
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Milton Biagioni, MD
role: PRINCIPAL_INVESTIGATOR
References: