Back to resultsIndividualized Precise Localization of rTMS on Precentral and Parietal Gyrus
Primary Purpose
Attention Deficit Hyperactivity Disorder
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
rTMS
Sponsored by
About this trial
This is an interventional treatment trial for Attention Deficit Hyperactivity Disorder focused on measuring fMRI, rTMS, functional connectivity
Eligibility Criteria
Inclusion Criteria:
- There are activation in dACC, motor area and parietal gyrus 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
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Sham Comparator
Arm Label
Real rTMS (motor area)
Real rTMS (parietal gyrus)
Real rTMS (both brain area)
Sham rTMS
Arm Description
Real rTMS targeting motor area for 30 min
Real rTMS targeting parietal gyrus for 30 min
Real rTMS targeting motor area and parietal gyrus for 15 min, separately
Sham rTMS targeting motor area and parietal gyrus for 15 min, separately
Outcomes
Primary Outcome Measures
degree of enhanced neuro-activity associated with target-specific treatment
amplitude of low frequency fluctuation
Secondary Outcome Measures
Full Information
NCT ID
NCT03515408
First Posted
April 6, 2018
Last Updated
August 5, 2019
Sponsor
Hangzhou Normal University
1. Study Identification
Unique Protocol Identification Number
NCT03515408
Brief Title
Individualized Precise Localization of rTMS on Precentral and Parietal Gyrus
Official Title
Individualized Precise Localization of rTMS on Precentral and Parietal Gyrus and Its Effects on Dorsal Anterior Cingulate Cortex
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
April 8, 2018 (Actual)
Primary Completion Date
November 1, 2018 (Actual)
Study Completion Date
November 1, 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
Attention deficit hyperactivity disorder (ADHD) patients have some problem with sustained attention. The dorsal anterior cingulate cortex (dACC) plays a key role for attention control. It has been found that the dACC has strong functional connectivity with ipsilateral motor area and parietal gyrus. 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 sustained attention, this project is using functional magnetic resonance imaging (fMRI) to individualize the precise localization in motor area and parietal gyrus, and combining rTMS to activate the dACC.
Detailed Description
Healthy subject is recruiting in this project. High rTMS will be performed. 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 with 27-s duration per train).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit Hyperactivity Disorder
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
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Real rTMS (motor area)
Arm Type
Experimental
Arm Description
Real rTMS targeting motor area for 30 min
Arm Title
Real rTMS (parietal gyrus)
Arm Type
Experimental
Arm Description
Real rTMS targeting parietal gyrus for 30 min
Arm Title
Real rTMS (both brain area)
Arm Type
Experimental
Arm Description
Real rTMS targeting motor area and parietal gyrus for 15 min, separately
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Sham rTMS targeting motor area and parietal gyrus for 15 min, separately
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
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 with 27-s duration per train).
Primary Outcome Measure Information:
Title
degree of enhanced neuro-activity associated with target-specific treatment
Description
amplitude of low frequency fluctuation
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 dACC, motor area and parietal gyrus 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
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
The IPD data cannot be shared with other researchers right now. We will shared it two years later.
Citations:
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
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
result
PubMed Identifier
26602957
Citation
Wang J, Yang N, Liao W, Zhang H, Yan CG, Zang YF, Zuo XN. Dorsal anterior cingulate cortex in typically developing children: Laterality analysis. Dev Cogn Neurosci. 2015 Oct;15:117-29. doi: 10.1016/j.dcn.2015.10.002.
Results Reference
result
Learn more about this trial
Individualized Precise Localization of rTMS on Precentral and Parietal Gyrus
We'll reach out to this number within 24 hrs