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

NCT ID: NCT01884493

Last Updated: 2014-08-08

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-07-31

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

real iTBS

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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 iTBS

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

Group Type: SHAM_COMPARATOR

real iTBS

Intervention Type: DEVICE

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

Intervention Type: DEVICE

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.

Interventions

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).

Intervention Type: 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.

Intervention Type: DEVICE

Eligibility 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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Science and Technology Council, Taiwan

OTHER_GOV

Sponsor Role: collaborator

China Medical University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Chon-Haw Tsai

The chief, Department of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

China Medical University Hospital/Neuro Depart

Taichung, , Taiwan

Countries

Taiwan

Other Identifiers

CMUH102-REC1-002

Identifier Type: -

Identifier Source: org_study_id