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Electrophysiological Investigation and rTMS Intervention of Ambulatory Central Processing of Freezing of Gait in Parkinson's Disease

Primary Purpose

Parkinson's Disease, Parkinson's Disease With Freezing of Gait

Status
Withdrawn
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
real iTBS
sham iTBS
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Parkinson's Disease focused on measuring Parkinson's Disease, Freezing of Gait, movement-related cortical potential, repetitive transcranial magnetic stimulation

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients with PD will be diagnosed according to the Brain Bank criteria.

Exclusion Criteria:

  1. Patients had past history of epilepsy, intracranial operation or brain tumor.
  2. Hoehn & Yahr Stage V.

Sites / Locations

  • China Medical University Hospital/Neuro Depart

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

real iTBS

sham iTBS

Arm Description

The paradigm will use a theta burst stimulation pattern (TBS) in which 3 pulses of stimulation will be given at 50Hz, repeated every 200 ms. In the iTBS, a 2-second train of TBS is repeated every 10 seconds for a total of 190 seconds (600 pulses). Subjects will be 8 courses of iTBS stimulation in 10 business days.

Subjects will be 8 courses of sham iTBS stimulation in 10 business days.

Outcomes

Primary Outcome Measures

Change in Laboratory gait analysis after 8 courses of iTBS
Variables in gait analysis:1.Gait initiation; 2.Level walking; 3.Turning; 4.Gait termination.

Secondary Outcome Measures

Change in Unified Parkinson's Disease Rating Scale (UPDRS) after 8 courses of iTBS
Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) after 8 courses of iTBS
Change in Fall assessment test after 8 courses
Change in Tinetti's Mobility Index after 8 courses of iTBS
Change in new freezing of gait questionnaire (FOG-Q) after 8 courses
Change in Patients' Global Impressions of Change (PGIC) Scale after 8 courses of iTBS
Change in Clinical Global Impressions (CGI) after 8 courses of iTBS

Full Information

First Posted
June 19, 2013
Last Updated
August 6, 2014
Sponsor
China Medical University Hospital
Collaborators
National Science Council, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT01884493
Brief Title
Electrophysiological Investigation and rTMS Intervention of Ambulatory Central Processing of Freezing of Gait in Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Withdrawn
Study Start Date
January 2014 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China Medical University Hospital
Collaborators
National Science Council, Taiwan

4. Oversight

5. Study Description

Brief Summary
The gait symptoms are usually refractory to the dopaminergic agents and some other resolutions, i.e. repetitive transcranial magnetic stimulation (rTMS) should be searched for in this regard. To study the impact of rTMS, investigators will adopt a domestically developed ambulatory recorder (PK-16CH EXG) for the concomitant recording of the electroencephalographic and electromyographic signals for PD patients when walking in the gait laboratory or when conducting leg dorsiflexion movement on sitting.
Detailed Description
The Bereitschaftspotential (BP), event related synchronization (ERS) and event related dysynchronization (ERD) will be analyzed for the investigation of the possible differences of brain activities prior to leg voluntary movement between patients and controls. In addition, the synchronized recorded gait parameters for gait ignition,turning and termination will also be analyzed. The information gathered will allow us to further understand the pathophysiology of the gait freezing in PD. Investigators will deliver a course of rTMS with intermittent theta burst paradigm of the leg motor cortex to investigate whether the non-invasive brain stimulation can ameliorate the gait freezing in PD patients. The subjects will be assessed before and 4 times after rTMS during an 8-week period with clinical scoring batteries and electrophysiological recording as aforementioned. At the end of the 8th week, the test group and sham group will cross over and undergo the same procedures as aforementioned. The serial comprehensive investigations in this project will not only promote our understanding of the gait freezing pathophysiology but also may charge a novel trail for the management of long suffering symptom of the PD patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Parkinson's Disease With Freezing of Gait
Keywords
Parkinson's Disease, Freezing of Gait, movement-related cortical potential, repetitive transcranial magnetic stimulation

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
real iTBS
Arm Type
Experimental
Arm Description
The paradigm will use a theta burst stimulation pattern (TBS) in which 3 pulses of stimulation will be given at 50Hz, repeated every 200 ms. In the iTBS, a 2-second train of TBS is repeated every 10 seconds for a total of 190 seconds (600 pulses). Subjects will be 8 courses of iTBS stimulation in 10 business days.
Arm Title
sham iTBS
Arm Type
Sham Comparator
Arm Description
Subjects will be 8 courses of sham iTBS stimulation in 10 business days.
Intervention Type
Device
Intervention Name(s)
real iTBS
Intervention Description
Theta-burst magnetic stimulation (TBS) is a repetitive transcranial magnetic stimulation (rTMS) technique that elicits long-lasting changes in the excitability of human primary motor cortex (M1).
Intervention Type
Device
Intervention Name(s)
sham iTBS
Intervention Description
The sham test will be done by transferring the double cone coil 90 degrees anteriorly and putting the lower edge of the coil of the vertex.
Primary Outcome Measure Information:
Title
Change in Laboratory gait analysis after 8 courses of iTBS
Description
Variables in gait analysis:1.Gait initiation; 2.Level walking; 3.Turning; 4.Gait termination.
Time Frame
baseline to week 8
Secondary Outcome Measure Information:
Title
Change in Unified Parkinson's Disease Rating Scale (UPDRS) after 8 courses of iTBS
Time Frame
baseline to week 8
Title
Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) after 8 courses of iTBS
Time Frame
baseline to week 8
Title
Change in Fall assessment test after 8 courses
Time Frame
baseline to week 8
Title
Change in Tinetti's Mobility Index after 8 courses of iTBS
Time Frame
baseline to week 8
Title
Change in new freezing of gait questionnaire (FOG-Q) after 8 courses
Time Frame
baseline to week 8
Title
Change in Patients' Global Impressions of Change (PGIC) Scale after 8 courses of iTBS
Time Frame
baseline to week 8
Title
Change in Clinical Global Impressions (CGI) after 8 courses of iTBS
Time Frame
baseline to week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with PD will be diagnosed according to the Brain Bank criteria. Exclusion Criteria: Patients had past history of epilepsy, intracranial operation or brain tumor. Hoehn & Yahr Stage V.
Facility Information:
Facility Name
China Medical University Hospital/Neuro Depart
City
Taichung
Country
Taiwan

12. IPD Sharing Statement

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Electrophysiological Investigation and rTMS Intervention of Ambulatory Central Processing of Freezing of Gait in Parkinson's Disease

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