NCT02741765

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

April 18, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 26, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2018

Completed
Last Updated

July 16, 2019

Status Verified

July 1, 2019

Enrollment Period

2.2 years

First QC Date

March 31, 2016

Last Update Submit

July 12, 2019

Conditions

Parkinson Disease

Keywords

Transcranial Magnetic StimulationExerciseBrain Plasticity

Outcome Measures

Primary Outcomes (2)

  • Recruitment Enrollment Numbers

    2 Weeks

  • Number of enrolled subjects that remain in study

    2 Weeks

Secondary Outcomes (10)

  • Plasticity measured by TMS-PAS25 (LTP-like plasticity biomarker)

    2 Weeks

  • Measurements of lymphocytes

    2 Weeks

  • Measurements of TrkB

    2 Weeks

  • Measurements of serum BDNF

    2 Weeks

  • Timed Up and Go Test

    2 Weeks

  • +5 more secondary outcomes

Study Arms (2)

Group 1: Sham Group

ACTIVE COMPARATOR

Sham group will receive Sham rTMS+Aerobic Exercise

Behavioral: Sham rTMSBehavioral: Supervised aerobic exercise

Group 2: Real Group

EXPERIMENTAL

rTMS+Aerobic Exercise

Other: Real rTMSBehavioral: Supervised aerobic exercise

Interventions

Sham rTMSBEHAVIORAL

Subjects will participate in daily sessions of sham-rTMS

Group 1: Sham Group
Real rTMSOTHER

Subjects will participate in a combination of rTMS

Group 2: Real Group
Supervised aerobic exerciseBEHAVIORAL
Group 1: Sham GroupGroup 2: Real Group

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.
  • Male or Female; aged 35-85

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Parkinson DiseaseMotor Activity

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavior

Study Officials

  • Milton Biagioni, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2016

First Posted

April 18, 2016

Study Start

November 1, 2015

Primary Completion

January 26, 2018

Study Completion

January 26, 2018

Last Updated

July 16, 2019

Record last verified: 2019-07

Locations

US(1)