Individualized Precise Localization of rTMS on Primary Motor Area

May 27, 2018 updated by: Yu-Feng ZANG, Hangzhou Normal University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310010
        • Hangzhou Normal University,Center for Cognition and Brain Disorder
      • Hangzhou, Zhejiang, China, 311121
        • Hangzhou Normal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
degree of enhanced neuro-activity associated with frequency-specific treatment
Time Frame: through study completion, an average of 1 year
functional connectivity
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hangzhou Normal University

Investigators

  • Principal Investigator: Yu-Feng Zang, M.D., Hangzhou Normal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 4, 2017

Primary Completion (Actual)

April 15, 2018

Study Completion (Actual)

April 15, 2018

Study Registration Dates

First Submitted

September 7, 2017

First Submitted That Met QC Criteria

April 6, 2018

First Posted (Actual)

April 13, 2018

Study Record Updates

Last Update Posted (Actual)

May 30, 2018

Last Update Submitted That Met QC Criteria

May 27, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HZNU_initiative_movement_rTMS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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