Repetitive Transcranial Magnetic Stimulation for Freezing of Gait

• Sponsor: Dongtan Sacred Heart Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT01853150
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Duration (Months): 63
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Parkinsonian Disorders	Device: rTMS Motor cortex; Device: rTMS Supplementary motor area	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Repetitive Transcranial Magnetic Stimulation for Freezing of Gait
• Study Start Date: Apr 1, 2013
• Actual Primary Completion Date: Jul 1, 2018
• Actual Study Completion Date: Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. The number of steps [2 days]

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

Secondary Outcome Measures

1. The completion time during the SWS test [2 days]

2. Freezing episodes of gait trajectory [2 days]

3. Patient and Clinical Global Impression Scale [2 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Dongtan Sacred Heart Hospital	Hwaseong Si	Gyeonggi-Do	Korea, Republic of	445-170

Sponsors and Collaborators

• Dongtan Sacred Heart Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Suk Yun Kang, MD, PhD, Dongtan Sacred Heart Hospital
• ClinicalTrials.gov Identifier: NCT01853150
• Other Study ID Numbers: 2013-022
• First Posted: May 14, 2013
• Last Update Posted: Jul 24, 2018
• Last Verified: Jul 1, 2018

• Additional relevant MeSH terms: Parkinsonian Disorders

Study Results

No Results Posted as of Jul 24, 2018