NCT01853150

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

April 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 10, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 14, 2013

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

July 24, 2018

Status Verified

July 1, 2018

Enrollment Period

5.3 years

First QC Date

May 10, 2013

Last Update Submit

July 23, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • The number of steps

    The number of steps during the stand-walk-sit (SWS) test

    2 days

Secondary Outcomes (3)

  • The completion time during the SWS test

    2 days

  • Freezing episodes of gait trajectory

    2 days

  • Patient and Clinical Global Impression Scale

    2 days

Study Arms (2)

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

rTMS Motor cortex
rTMS Supplementary motor area

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dongtan Sacred Heart Hospital

Hwaseong-si, Gyeonggi-do, 445-170, South Korea

Location

MeSH Terms

Conditions

Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement Disorders

Study Design

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

Study Record Dates

First Submitted

May 10, 2013

First Posted

May 14, 2013

Study Start

April 1, 2013

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

July 24, 2018

Record last verified: 2018-07

Locations