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

Parkinson's Disease Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01884493
• Other study ID #: CMUH102-REC1-002
• Status: Withdrawn
• Phase: N/A
• First received: June 19, 2013
• Last updated: August 6, 2014
• Start date: January 2014
• Est. completion date: July 2014

Study information

• Verified date: January 2014
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Taiwan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 85 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

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

Intervention

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).
• 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.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital/Neuro Depart	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	National Science Council, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	baseline to week 8	No
Secondary	Change in Unified Parkinson's Disease Rating Scale (UPDRS) after 8 courses of iTBS		baseline to week 8	No
Secondary	Change in The 39-item Parkinson's Disease Questionnaire (PDQ-39) after 8 courses of iTBS		baseline to week 8	No
Secondary	Change in Fall assessment test after 8 courses		baseline to week 8	No
Secondary	Change in Tinetti's Mobility Index after 8 courses of iTBS		baseline to week 8	No
Secondary	Change in new freezing of gait questionnaire (FOG-Q) after 8 courses		baseline to week 8	No
Secondary	Change in Patients' Global Impressions of Change (PGIC) Scale after 8 courses of iTBS		baseline to week 8	No
Secondary	Change in Clinical Global Impressions (CGI) after 8 courses of iTBS		baseline to week 8	No