Individualized Precise Localization of rTMS on Primary Motor Area
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring fMRI, rTMS, functional connectivity
Eligibility Criteria
Inclusion Criteria:
- There are activation in motor area during the task fMRI
- The head motion less than 2 mm in translation or 2 degrees in rotation in any direction during the resting-state fMRI
Exclusion Criteria:
- Without any neuropsychiatric conditions
- No head injury or history of epilepsy
- Not on any medications
Sites / Locations
- Hangzhou Normal University,Center for Cognition and Brain Disorder
- Hangzhou Normal University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Sham Comparator
Experimental
Arm Label
Real rTMS (low frequency)
Sham rTMS
Real rTMS (high frequency)
Arm Description
Real rTMS (low frequency) is 1Hz.
Sham rTMS session includes low frequency and high frequency stimulations.
Real rTMS (high frequency) is 10Hz.
Outcomes
Primary Outcome Measures
degree of enhanced neuro-activity associated with frequency-specific treatment
functional connectivity
Secondary Outcome Measures
Full Information
NCT ID
NCT03497884
First Posted
September 7, 2017
Last Updated
May 27, 2018
Sponsor
Hangzhou Normal University
1. Study Identification
Unique Protocol Identification Number
NCT03497884
Brief Title
Individualized Precise Localization of rTMS on Primary Motor Area
Official Title
Individualized Precise Localization of rTMS on Primary Motor Area and Its Effects on Basal Ganglia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
September 4, 2017 (Actual)
Primary Completion Date
April 15, 2018 (Actual)
Study Completion Date
April 15, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hangzhou Normal University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Parkinson's disease (PD) patients have some problem with self-initiated movement task. Compared with health controls, task meta-analysis found that PD patients showed abnormal activation in pre-supplementary motor area (pre-SMA) and putamen. And the functional connectivity has already been reported between pre-SMA and putamen in 2013. Repetitive Transcranial Magnetic Stimulation (rTMS) is a sage and painless technique to activate cortical areas. The deep brain structure can be activated via stimulating superficial cortex by rTMS. For investigating the mechanism of self-initiated movement, this project is using functional magnetic resonance imaging (fMRI) to individualize the precise localization in motor area and combining rTMS to activate putamen.
Detailed Description
Healthy subject is recruiting in this project. High and low frequency rTMS will be performed, respectively. For the l-Hz sessions (low frequency), stimulation is delivered at 100% of the subject's resting motor threshold at 1 Hz continuously over 30 min for a total of 1,800 pluses. The 10-Hz stimulation is delivered at 100% of the subject's resting motor threshold via 60 trains of 3-s 10-Hz rTMS (30 pulses per train).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
fMRI, rTMS, functional connectivity
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Real rTMS (low frequency)
Arm Type
Experimental
Arm Description
Real rTMS (low frequency) is 1Hz.
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Sham rTMS session includes low frequency and high frequency stimulations.
Arm Title
Real rTMS (high frequency)
Arm Type
Experimental
Arm Description
Real rTMS (high frequency) is 10Hz.
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
For the l-Hz sessions (low frequency), stimulation is delivered at 100% of the subject's resting motor threshold at 1 Hz continuously over 30 min for a total of 1,800 pluses. The 10-Hz stimulation (high frequency) is delivered at 100% of the subject's resting motor threshold via 60 trains of 3-s 10-Hz rTMS (30 pulses per train).
Primary Outcome Measure Information:
Title
degree of enhanced neuro-activity associated with frequency-specific treatment
Description
functional connectivity
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
There are activation in motor area during the task fMRI
The head motion less than 2 mm in translation or 2 degrees in rotation in any direction during the resting-state fMRI
Exclusion Criteria:
Without any neuropsychiatric conditions
No head injury or history of epilepsy
Not on any medications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yu-Feng Zang, M.D.
Organizational Affiliation
Hangzhou Normal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hangzhou Normal University,Center for Cognition and Brain Disorder
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310010
Country
China
Facility Name
Hangzhou Normal University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
311121
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25170153
Citation
Wang JX, Rogers LM, Gross EZ, Ryals AJ, Dokucu ME, Brandstatt KL, Hermiller MS, Voss JL. Targeted enhancement of cortical-hippocampal brain networks and associative memory. Science. 2014 Aug 29;345(6200):1054-7. doi: 10.1126/science.1252900.
Results Reference
background
PubMed Identifier
22160708
Citation
Eldaief MC, Halko MA, Buckner RL, Pascual-Leone A. Transcranial magnetic stimulation modulates the brain's intrinsic activity in a frequency-dependent manner. Proc Natl Acad Sci U S A. 2011 Dec 27;108(52):21229-34. doi: 10.1073/pnas.1113103109. Epub 2011 Dec 12.
Results Reference
result
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Individualized Precise Localization of rTMS on Primary Motor Area
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