Attention Deficit Hyperactivity DisorderNCT03515408
Individualized Precise Localization of rTMS on Precentral and Parietal Gyrus
A study testing rTMS in people with Attention Deficit Hyperactivity Disorder, run by Hangzhou Normal University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- rTMS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 1 siteChina
- Study dates
- 8 Apr 2018to 1 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Without any neuropsychiatric conditions
- No head injury or history of epilepsy
- Not on any medications
Trial locations and contacts
1 site in 1 country.
China1 site
Hangzhou Normal University,Center for Cognition and Brain Disorder
Hangzhou, Zhejiang, 310010
About this study
Official title: Individualized Precise Localization of rTMS on Precentral and Parietal Gyrus and Its Effects on Dorsal Anterior Cingulate Cortex
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.
Read the 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).
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- rTMS
- Keywords
- fMRI, rTMS, functional connectivity
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Real rTMS (motor area) | Experimental | Real rTMS targeting motor area for 30 min Receives: Device: rTMS |
| Real rTMS (parietal gyrus) | Experimental | Real rTMS targeting parietal gyrus for 30 min Receives: Device: rTMS |
| Real rTMS (both brain area) | Experimental | Real rTMS targeting motor area and parietal gyrus for 15 min, separately Receives: Device: rTMS |
| Sham rTMS | Sham comparator | Sham rTMS targeting motor area and parietal gyrus for 15 min, separately Receives: Device: rTMS |
What is being measured
The primary outcome is the main question the study is designed to answer.
degree of enhanced neuro-activity associated with target-specific treatment
amplitude of low frequency fluctuation
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2018
- Study start8 Apr 2018
- Primary completion1 Nov 2018
- Study completion1 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yu-Feng ZANG, Hangzhou Normal University
- Investigators
- Yu-Feng Zang, M.D., Principal investigator, Hangzhou Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03515408
- Sponsor's protocol ID
- HZNU_sustainded_attention_rTMS
- Status last verified
- Aug 2019
- First submitted
- 6 Apr 2018
- Last updated
- 7 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD data cannot be shared with other researchers right now. We will shared it two years later.
Publications
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.
PubMed 22160708Wang 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.
PubMed 25170153Wang 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.
PubMed 26602957
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Precise Localization of rTMS on Precentral and Parietal Gyrus and Its Effects on Dorsal Anterior Cingulate Cortex
- ClinicalTrials.gov ID
- NCT03515408
- Acronym / sponsor ID
- HZNU_sustainded_attention_rTMS
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- fMRI, rTMS, functional connectivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- 8 Apr 2018 (actual)
- Primary completion
- 1 Nov 2018 (actual)
- Study completion
- 1 Nov 2018 (actual)
- First posted
- 3 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Real rTMS (motor area) | Experimental | Device: rTMSReal rTMS targeting motor area for 30 min |
| Real rTMS (parietal gyrus) | Experimental | Device: rTMSReal rTMS targeting parietal gyrus for 30 min |
| Real rTMS (both brain area) | Experimental | Device: rTMSReal rTMS targeting motor area and parietal gyrus for 15 min, separately |
| Sham rTMS | Sham comparator | Device: rTMSSham rTMS targeting motor area and parietal gyrus for 15 min, separately |
Who may qualify
- Ages
- 19 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Without any neuropsychiatric conditions
- No head injury or history of epilepsy
- Not on any medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| rTMSThe 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). | Device | Real rTMS (both brain area), Real rTMS (motor area), Real rTMS (parietal gyrus), Sham rTMS |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Results publication: PubMed 22160708Eldaief 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 publication: PubMed 25170153Wang 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 publication: PubMed 26602957Wang 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.
- Individual participant dataSharing planned: No. The IPD data cannot be shared with other researchers right now. We will shared it two years later.
Related trials for Attention Deficit Hyperactivity Disorder
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruitingPhase 2
Lisdexamfetamine For the Treatment of Conduct Disorder in Children
Conduct Disorder
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
Recruiting
Micronutrient Supplementation and Chronotherapy in Children With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
RecruitingPhase 3
Forward Treatment of Attention Deficit and Hyperactivity Using Solriamfetol (FOCUS-2)
ADHD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yu-Feng Zang, M.D. principal investigator
Hangzhou Normal University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rTMS in people with Attention Deficit Hyperactivity Disorder, run by Hangzhou Normal University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
degree of enhanced neuro-activity associated with target-specific treatment (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03515408, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2019.