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

July 12, 2019 updated by: NYU Langone Health
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

35 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
Behavioral: Supervised aerobic exercise
Other: Real rTMS
Subjects will participate in a combination of rTMS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Recruitment Enrollment Numbers
Time Frame: 2 Weeks
2 Weeks
Number of enrolled subjects that remain in study
Time Frame: 2 Weeks
2 Weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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 Weeks
Measurements of lymphocytes
Time Frame: 2 Weeks
2 Weeks
Measurements of TrkB
Time Frame: 2 Weeks
2 Weeks
Measurements of serum BDNF
Time Frame: 2 Weeks
2 Weeks
Timed Up and Go Test
Time Frame: 2 Weeks
2 Weeks
Freezing of Gait Questionnaire (FOG-Q)
Time Frame: 2 Weeks
2 Weeks
Parkinson's Disease Quality of Life (PDQ-39)
Time Frame: 2 Weeks
2 Weeks
Parkinson's Disease Sleep Scale (PDSS)
Time Frame: 2 Weeks
2 Weeks
Frontal Function Assessment (FAB)
Time Frame: 2 Weeks
2 Weeks
LASA Physical Activity Questionnaire (LAPAQ)
Time Frame: 2 Weeks
2 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
NYU Langone Health

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Milton Biagioni, MD, New York University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 26, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 26, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 31, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 15-00712

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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