Individualized Precise Localization of rTMS on Primary Motor Area

NCT ID: NCT03497884

Last Updated: 2018-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-04

Study Completion Date

2018-04-15

Brief Summary

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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

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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

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Real rTMS (low frequency)

Real rTMS (low frequency) is 1Hz.

Group Type EXPERIMENTAL

rTMS

Intervention Type DEVICE

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).

Sham rTMS

Sham rTMS session includes low frequency and high frequency stimulations.

Group Type SHAM_COMPARATOR

rTMS

Intervention Type DEVICE

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).

Real rTMS (high frequency)

Real rTMS (high frequency) is 10Hz.

Group Type EXPERIMENTAL

rTMS

Intervention Type DEVICE

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).

Interventions

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rTMS

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).

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* Without any neuropsychiatric conditions
* No head injury or history of epilepsy
* Not on any medications
Minimum Eligible Age

19 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Hangzhou Normal University

OTHER

Sponsor Role lead

Responsible Party

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Yu-Feng ZANG

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yu-Feng Zang, M.D.

Role: PRINCIPAL_INVESTIGATOR

Hangzhou Normal University

Locations

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Hangzhou Normal University,Center for Cognition and Brain Disorder

Hangzhou, Zhejiang, China

Site Status

Hangzhou Normal University

Hangzhou, Zhejiang, China

Site Status

Countries

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China

References

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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.

Reference Type BACKGROUND
PMID: 25170153 (View on PubMed)

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.

Reference Type RESULT
PMID: 22160708 (View on PubMed)

Other Identifiers

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HZNU_initiative_movement_rTMS

Identifier Type: -

Identifier Source: org_study_id

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