NCT03515408

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

April 6, 2018

Completed
2 days until next milestone

Study Start

First participant enrolled

April 8, 2018

Completed
25 days until next milestone

First Posted

Study publicly available on registry

May 3, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2018

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

7 months

First QC Date

April 6, 2018

Last Update Submit

August 5, 2019

Conditions

Attention Deficit Hyperactivity Disorder

Keywords

fMRIrTMSfunctional connectivity

Outcome Measures

Primary Outcomes (1)

  • degree of enhanced neuro-activity associated with target-specific treatment

    amplitude of low frequency fluctuation

    through study completion, an average of 1 year

Study Arms (4)

Real rTMS (motor area)

EXPERIMENTAL

Real rTMS targeting motor area for 30 min

Device: rTMS

Real rTMS (parietal gyrus)

EXPERIMENTAL

Real rTMS targeting parietal gyrus for 30 min

Device: rTMS

Real rTMS (both brain area)

EXPERIMENTAL

Real rTMS targeting motor area and parietal gyrus for 15 min, separately

Device: rTMS

Sham rTMS

SHAM COMPARATOR

Sham rTMS targeting motor area and parietal gyrus for 15 min, separately

Device: rTMS

Interventions

rTMSDEVICE

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).

Real rTMS (both brain area)Real rTMS (motor area)Real rTMS (parietal gyrus)Sham rTMS

Eligibility Criteria

Age19 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Without any neuropsychiatric conditions
  • No head injury or history of epilepsy
  • Not on any medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hangzhou Normal University,Center for Cognition and Brain Disorder

Hangzhou, Zhejiang, 310010, China

Location

Related Publications (3)

  • 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.

    PMID: 22160708RESULT

  • 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.

    PMID: 25170153RESULT

  • 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.

    PMID: 26602957RESULT

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Yu-Feng Zang, M.D.

    Hangzhou Normal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 6, 2018

First Posted

May 3, 2018

Study Start

April 8, 2018

Primary Completion

November 1, 2018

Study Completion

November 1, 2018

Last Updated

August 7, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

The IPD data cannot be shared with other researchers right now. We will shared it two years later.

Locations

CN(1)