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Completed

NCT Number: NCT02741765

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

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.

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Key information

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

New York University School of Medicine

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sham rTMS

Behavioral

Subjects will participate in daily sessions of sham-rTMS

Real rTMS

Other

Subjects will participate in a combination of rTMS

Supervised Aerobic Exercise

Behavioral

Primary outcomes

  1. Recruitment Enrollment Numbers

    Time frame: 2 Weeks

  2. Number of enrolled subjects that remain in study

    Time frame: 2 Weeks

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 18, 2016
Registry last updated
Jul 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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