Individualized Precise Localization of rTMS on Primary Motor Area

Parkinson Disease Clinical Trial

Official title:

Individualized Precise Localization of rTMS on Primary Motor Area and Its Effects on Basal Ganglia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03497884
• Other study ID #: HZNU_initiative_movement_rTMS
• Status: Completed
• Phase: N/A
• Start date: September 4, 2017
• Est. completion date: April 15, 2018

Study information

• Verified date: May 2018
• Source: Hangzhou Normal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: April 15, 2018
• Est. primary completion date: April 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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).

Locations

Country	Name	City	State
China	Hangzhou Normal University	Hangzhou	Zhejiang
China	Hangzhou Normal University,Center for Cognition and Brain Disorder	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Hangzhou Normal University

Country where clinical trial is conducted

China, 

References & Publications (2)

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 — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	degree of enhanced neuro-activity associated with frequency-specific treatment	functional connectivity	through study completion, an average of 1 year