Individualized Precise Localization of rTMS on Primary Motor Area and Its Effects on Basal Ganglia
| Registry | NCT03497884 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 38 (Actual) |
| Sponsor | Hangzhou Normal University (Other) |
| Conditions | Parkinson Disease |
| Interventions | rTMS (Device) |
| Dates | start 2017-09-04, primary completion 2018-04-15, completion 2018-04-15, first posted 2018-04-13, last updated 2018-05-30 |
| Locations | 2 sites in China |
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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.
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Real rTMS (low frequency) | Experimental | Device: rTMS | Real rTMS (low frequency) is 1Hz. |
| Sham rTMS | Sham comparator | Device: rTMS | Sham rTMS session includes low frequency and high frequency stimulations. |
| Real rTMS (high frequency) | Experimental | Device: rTMS | Real rTMS (high frequency) is 10Hz. |
Sex: All, ages: 19 Years to 30 Years, accepts healthy volunteers
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
| Facility | City | Country | Status |
|---|---|---|---|
| Hangzhou Normal University,Center for Cognition and Brain Disorder | Hangzhou, Zhejiang | China | |
| Hangzhou Normal University | Hangzhou, Zhejiang | China |