Repetitive Transcranial Magnetic Stimulation for Freezing of Gait

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Dongtan Sacred Heart Hospital
Sponsor:
Information provided by (Responsible Party):
Suk Yun Kang, Dongtan Sacred Heart Hospital
ClinicalTrials.gov Identifier:
NCT01853150
First received: May 10, 2013
Last updated: February 13, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Parkinsonian Disorders
Device: rTMS Motor cortex
Device: rTMS Supplementary motor area

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Dongtan Sacred Heart Hospital:

Primary Outcome Measures:
  • The number of steps [ Time Frame: 2 days ] [ Designated as safety issue: No ]
    The number of steps during the stand-walk-sit (SWS) test


Secondary Outcome Measures:
  • The completion time during the SWS test [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Freezing episodes of gait trajectory [ Time Frame: 2 days ] [ Designated as safety issue: No ]
  • Patient and Clinical Global Impression Scale [ Time Frame: 2 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2013
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: rTMS Motor cortex
rTMS will be applied over the motor cortex
Device: rTMS Motor cortex
Active Comparator: rTMS Supplementary motor area
rTMS will be applied over the supplementary motor area
Device: rTMS Supplementary motor area

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01853150

Contacts
Contact: Suk Yun Kang, MD, PhD +82-31-8086-2310 sukyunkang@hanmail.net

Locations
Korea, Republic of
Dongtan Sacred Heart Hospital Recruiting
Hwaseong Si, Gyeonggi-Do, Korea, Republic of, 445-170
Sponsors and Collaborators
Dongtan Sacred Heart Hospital
  More Information

No publications provided

Responsible Party: Suk Yun Kang, MD, PhD, Dongtan Sacred Heart Hospital
ClinicalTrials.gov Identifier: NCT01853150     History of Changes
Other Study ID Numbers: 2013-022
Study First Received: May 10, 2013
Last Updated: February 13, 2014
Health Authority: Korea: Institutional Review Board

Additional relevant MeSH terms:
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders

ClinicalTrials.gov processed this record on July 23, 2014