Parkinson DiseaseNCT03497884
Individualized Precise Localization of rTMS on Primary Motor Area
A study testing rTMS in people with Parkinson Disease, run by Hangzhou Normal University at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- 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
- 38 participants
- Where
- 2 sitesChina
- Study dates
- 4 Sep 2017to 15 Apr 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 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
Who cannot join
- Without any neuropsychiatric conditions
- No head injury or history of epilepsy
- Not on any medications
Trial locations and contacts
2 sites in 1 country.
China2 sites
Hangzhou Normal University,Center for Cognition and Brain Disorder
Hangzhou, Zhejiang, 310010
Hangzhou Normal University
Hangzhou, Zhejiang, 311121
About this study
Official title: Individualized Precise Localization of rTMS on Primary Motor Area and Its Effects on Basal Ganglia
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.
Read the 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).
- Conditions
- Parkinson Disease
- Being tested
- rTMS
- Keywords
- fMRI, rTMS, functional connectivity
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rTMSDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Real rTMS (low frequency) | Experimental | Real rTMS (low frequency) is 1Hz. Receives: Device: rTMS |
| Sham rTMS | Sham comparator | Sham rTMS session includes low frequency and high frequency stimulations. Receives: Device: rTMS |
| Real rTMS (high frequency) | Experimental | Real rTMS (high frequency) is 10Hz. 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 frequency-specific treatment
functional connectivity
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 posted13 Apr 2018
- Study start4 Sep 2017
- Primary completion15 Apr 2018
- Study completion15 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies 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
- 38 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
- NCT03497884
- Sponsor's protocol ID
- HZNU_initiative_movement_rTMS
- Status last verified
- May 2018
- First submitted
- 7 Sep 2017
- Last updated
- 30 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 25170153Eldaief 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 22160708
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Individualized Precise Localization of rTMS on Primary Motor Area and Its Effects on Basal Ganglia
- ClinicalTrials.gov ID
- NCT03497884
- Acronym / sponsor ID
- HZNU_initiative_movement_rTMS
- Conditions
- Parkinson Disease
- Keywords
- fMRI, rTMS, functional connectivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Hangzhou Normal UniversityUniversity, hospital or other
- Study start
- 4 Sep 2017 (actual)
- Primary completion
- 15 Apr 2018 (actual)
- Study completion
- 15 Apr 2018 (actual)
- First posted
- 13 Apr 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.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Real rTMS (low frequency) | Experimental | Device: rTMSReal rTMS (low frequency) is 1Hz. |
| Sham rTMS | Sham comparator | Device: rTMSSham rTMS session includes low frequency and high frequency stimulations. |
| Real rTMS (high frequency) | Experimental | Device: rTMSReal rTMS (high frequency) is 10Hz. |
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 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
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 |
|---|---|---|
| rTMSFor 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). | Device | Real rTMS (high frequency), Real rTMS (low frequency), Sham rTMS |
Primary outcome
degree of enhanced neuro-activity associated with frequency-specific treatment
Time frame: through study completion, an average of 1 year
functional connectivity
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 30 May 2018.
- Background: 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 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.
- Individual participant dataSharing planned: Undecided
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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
2 sites 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 Parkinson Disease, run by Hangzhou Normal University at 2 sites 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 30 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 frequency-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 NCT03497884, which also lists 2 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 30 May 2018.