Repetitive Transcranial Magnetic Stimulation for Freezing... | NCT01853150

Studies
Repetitive Transcranial Magnetic Stimulation for Freezing of Gait

NCT01853150

Sponsor

Dongtan Sacred Heart Hospital

Status

Completed

Last Update Posted

Jul 24, 2018Actual

Enrollment

12Actual

Phase

Not Applicable

Conditions

Parkinsonian Disorders

Interventions

rTMS Motor cortex
rTMS Supplementary motor area

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Jul 2018Actual

Completion Date

Jul 2018Actual

First Submitted Date

May 10, 2013

First Submission Date that Met QC Criteria

May 10, 2013

First Posted Date

May 14, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2018

Last Update Posted Date

Jul 24, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Freezing of gait (FOG) means that patients cannot walk without any known causes, other than parkinsonism, which is very disabling symptom. Patients descirbe their feeling of the feet suddenly being glued to the floor. Transcranial magnetic stiumation is a noninvasive procedure using electromagnetic induction to stimulate brain. Transcranial magnetic stiumation (rTMS) can selectively change brain activity to enhance desired effects. The aim of this study is to the therapeutic effect of rTMS for the FOG.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
rTMS Motor cortex	Experimental	rTMS will be applied over the motor cortex	Device: rTMS Motor cortex
rTMS Supplementary motor area	Active Comparator	rTMS will be applied over the supplementary motor area	Device: rTMS Supplementary motor area

Interventions

Name	Type	Description	Arm Group Labels	Other Names
rTMS Motor cortex	Device		rTMS Motor cortex
rTMS Supplementary motor area

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of steps	The number of steps during the stand-walk-sit (SWS) test	2 days

Secondary Outcomes

Measure	Description	Time Frame
The completion time during the SWS test		2 days
Freezing episodes of gait trajectory		2 days
Patient and Clinical Global Impression Scale

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Parkinson's disease or Primary progressive freezing of gait
age 18 and older
Freezing of gait

Exclusion Criteria:

pregnant or any, other medical, surgical, neurological or psychiatric conditions
other restrictions which prevent you from undergoing TMS recording, such as; surgically or traumatically implanted foreign bodies such as a pacemaker, an implanted medication pump, a metal plate in the skull, or metal inside the skull or eyes (other than dental appliances or fillings), and/ or heart/cardiac lines
any past or current history of seizure disorder or epilepsy
unable to give informed consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dongtan Sacred Heart Hospital		Hwaseong-si	Gyeonggi-do	445-170	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D020734	Parkinsonian Disorders

Ancestor Terms

ID	Term
D001480	Basal Ganglia Diseases
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided