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Individualized Precise Localization of rTMS on Primary Motor Area

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ClinicalTrials.gov Identifier: NCT03497884
Recruitment Status : Completed
First Posted : April 13, 2018
Last Update Posted : May 30, 2018
Sponsor:
Information provided by (Responsible Party):
Yu-Feng ZANG, Hangzhou Normal University

Study Description
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Brief 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. 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.

Condition or disease Intervention/treatment Phase
Parkinson Disease Device: rTMS Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Individualized Precise Localization of rTMS on Primary Motor Area and Its Effects on Basal Ganglia
Actual Study Start Date : September 4, 2017
Actual Primary Completion Date : April 15, 2018
Actual Study Completion Date : April 15, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Real rTMS (low frequency)
Real rTMS (low frequency) is 1Hz.
 Device: 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).
Sham Comparator: Sham rTMS
Sham rTMS session includes low frequency and high frequency stimulations.
 Device: 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).
Experimental: Real rTMS (high frequency)
Real rTMS (high frequency) is 10Hz.
 Device: 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).


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


Eligibility Criteria
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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 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
Contacts and Locations
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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): NCT03497884


Locations
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China, Zhejiang
Hangzhou Normal University,Center for Cognition and Brain Disorder
Hangzhou, Zhejiang, China, 310010
Hangzhou Normal University
Hangzhou, Zhejiang, China, 311121
Sponsors and Collaborators
Hangzhou Normal University
Investigators
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Principal Investigator: Yu-Feng Zang, M.D. Hangzhou Normal University
More Information
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Publications of Results:

Other Publications:

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Responsible Party: Yu-Feng ZANG, Professor, Hangzhou Normal University
ClinicalTrials.gov Identifier: NCT03497884    
Other Study ID Numbers: HZNU_initiative_movement_rTMS
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: May 30, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases