Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Individualized Precise Localization of rTMS on Precentral and Parietal Gyrus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03515408
Recruitment Status : Completed
First Posted : May 3, 2018
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Yu-Feng ZANG, Hangzhou Normal University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Attention Deficit Hyperactivity Disorder Device: rTMS Not Applicable

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).
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Individualized Precise Localization of rTMS on Precentral and Parietal Gyrus and Its Effects on Dorsal Anterior Cingulate Cortex
Actual Study Start Date : April 8, 2018
Actual Primary Completion Date : November 1, 2018
Actual Study Completion Date : November 1, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Real rTMS (motor area)
Real rTMS targeting motor area for 30 min
 Device: rTMS
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).
Experimental: Real rTMS (parietal gyrus)
Real rTMS targeting parietal gyrus for 30 min
 Device: rTMS
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).
Experimental: Real rTMS (both brain area)
Real rTMS targeting motor area and parietal gyrus for 15 min, separately
 Device: rTMS
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).
Sham Comparator: Sham rTMS
Sham rTMS targeting motor area and parietal gyrus for 15 min, separately
 Device: rTMS
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).


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. degree of enhanced neuro-activity associated with target-specific treatment [ Time Frame: through study completion, an average of 1 year ]
    amplitude of low frequency fluctuation


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03515408


Locations
Layout table for location information
China, Zhejiang
Hangzhou Normal University,Center for Cognition and Brain Disorder
Hangzhou, Zhejiang, China, 310010
Sponsors and Collaborators
Hangzhou Normal University
Investigators
Layout table for investigator information
Principal Investigator: Yu-Feng Zang, M.D. Hangzhou Normal University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications of Results:

Layout table for additonal information
Responsible Party: Yu-Feng ZANG, Professor, Hangzhou Normal University
ClinicalTrials.gov Identifier: NCT03515408    
Other Study ID Numbers: HZNU_sustainded_attention_rTMS
First Posted: May 3, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The IPD data cannot be shared with other researchers right now. We will shared it two years later.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yu-Feng ZANG, Hangzhou Normal University:
fMRI
rTMS
functional connectivity
Additional relevant MeSH terms:
Layout table for MeSH terms
Attention Deficit Disorder with Hyperactivity
Attention Deficit and Disruptive Behavior Disorders
Neurodevelopmental Disorders
Mental Disorders