NCT03497884

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable parkinson-disease

Timeline
Completed

Started Sep 2017

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 4, 2017

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2017

Completed
7 months until next milestone

First Posted

Study publicly available on registry

April 13, 2018

Completed
2 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2018

Completed
Last Updated

May 30, 2018

Status Verified

May 1, 2018

Enrollment Period

7 months

First QC Date

September 7, 2017

Last Update Submit

May 27, 2018

Conditions

Parkinson Disease

Keywords

fMRIrTMSfunctional connectivity

Outcome Measures

Primary Outcomes (1)

  • degree of enhanced neuro-activity associated with frequency-specific treatment

    functional connectivity

    through study completion, an average of 1 year

Study Arms (3)

Real rTMS (low frequency)

EXPERIMENTAL

Real rTMS (low frequency) is 1Hz.

Device: rTMS

Sham rTMS

SHAM COMPARATOR

Sham rTMS session includes low frequency and high frequency stimulations.

Device: rTMS

Real rTMS (high frequency)

EXPERIMENTAL

Real rTMS (high frequency) is 10Hz.

Device: rTMS

Interventions

rTMSDEVICE

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 (low frequency)Sham rTMS

Eligibility Criteria

Age19 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Without any neuropsychiatric conditions
  • No head injury or history of epilepsy
  • Not on any medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hangzhou Normal University,Center for Cognition and Brain Disorder

Hangzhou, Zhejiang, 310010, China

Location

Hangzhou Normal University

Hangzhou, Zhejiang, 311121, China

Location

Related Publications (2)

  • 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.

    PMID: 25170153BACKGROUND

  • 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.

    PMID: 22160708RESULT

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Yu-Feng Zang, M.D.

    Hangzhou Normal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 7, 2017

First Posted

April 13, 2018

Study Start

September 4, 2017

Primary Completion

April 15, 2018

Study Completion

April 15, 2018

Last Updated

May 30, 2018

Record last verified: 2018-05

Locations

CN(2)