Ignite Creation Date:
2024-05-06 @ 8:28 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02741765
Status:
COMPLETED
Last Update Posted:
2019-07-16
First Post:
2016-03-31
Brief Title:
Exercise and Transcranial Magnetic Stimulation Increasing Brain Plasticity in Parkinsons Disease
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Exercise and Transcranial Magnetic Stimulation Increasing Brain Plasticity in Parkinsons Disease
Status:
COMPLETED
Status Verified Date:
2019-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Parkinsons 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 n24 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 rTMSAerobic in Group 2 subjects will participate in a combination of rTMS and supervised aerobic exercise Real rTMSAerobic 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 n12 will be analyzed to establish the effect of the disease on indices of plasticity
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None