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

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
National Science Council, Taiwan
Information provided by (Responsible Party):
Chon-Haw Tsai, China Medical University Hospital
ClinicalTrials.gov Identifier:
NCT01884493
First received: June 19, 2013
Last updated: August 6, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Parkinson's Disease
Parkinson's Disease With Freezing of Gait
Device: real iTBS
Device: sham iTBS

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Basic Science

Resource links provided by NLM:


Further study details as provided by China Medical University Hospital:

Primary Outcome Measures:
  • Change in Laboratory gait analysis after 8 courses of iTBS [ Time Frame: baseline to week 8 ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline to week 8 ] [ Designated as safety issue: No ]
  • Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) after 8 courses of iTBS [ Time Frame: baseline to week 8 ] [ Designated as safety issue: No ]
  • Change in Fall assessment test after 8 courses [ Time Frame: baseline to week 8 ] [ Designated as safety issue: No ]
  • Change in Tinetti's Mobility Index after 8 courses of iTBS [ Time Frame: baseline to week 8 ] [ Designated as safety issue: No ]
  • Change in new freezing of gait questionnaire (FOG-Q) after 8 courses [ Time Frame: baseline to week 8 ] [ Designated as safety issue: No ]
  • Change in Patients' Global Impressions of Change (PGIC) Scale after 8 courses of iTBS [ Time Frame: baseline to week 8 ] [ Designated as safety issue: No ]
  • Change in Clinical Global Impressions (CGI) after 8 courses of iTBS [ Time Frame: baseline to week 8 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: January 2014
Study Completion Date: July 2014
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: real iTBS
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.
Device: real iTBS
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).
Device: sham iTBS
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.
Sham Comparator: sham iTBS
Subjects will be 8 courses of sham iTBS stimulation in 10 business days.
Device: real iTBS
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).
Device: sham iTBS
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01884493

Locations
Taiwan
China Medical University Hospital/Neuro Depart
Taichung, Taiwan
Sponsors and Collaborators
China Medical University Hospital
National Science Council, Taiwan
  More Information

No publications provided

Responsible Party: Chon-Haw Tsai, The chief, Department of Neurology, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT01884493     History of Changes
Other Study ID Numbers: CMUH102-REC1-002
Study First Received: June 19, 2013
Last Updated: August 6, 2014
Health Authority: Taiwan: Research Ethics Committee

Keywords provided by China Medical University Hospital:
Parkinson's Disease
Freezing of Gait
movement-related cortical potential
repetitive transcranial magnetic stimulation

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

ClinicalTrials.gov processed this record on October 23, 2014