Repetitive Transcranial Magnetic Stimulation for Freezing of Gait
1 other identifier
interventional
12
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Apr 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 10, 2013
CompletedFirst Posted
Study publicly available on registry
May 14, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2018
CompletedJuly 24, 2018
July 1, 2018
5.3 years
May 10, 2013
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
EXPERIMENTALrTMS will be applied over the motor cortex
rTMS Supplementary motor area
ACTIVE COMPARATORrTMS will be applied over the supplementary motor area
Interventions
Eligibility Criteria
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
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