Neurophysiological Dissection and Intervention of Freezing of Gait in Parkinson's Disease

Parkinson's Disease With Freezing of Gait Clinical Trial

Official title:

Neurophysiological Dissection and Intervention of Freezing of Gait in Parkinson's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03127475
• Other study ID #: CMUH105-REC1-004
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 1, 2016
• Est. completion date: October 31, 2018

Study information

• Verified date: September 2018
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Different conditions of gait ignition freezing, spontaneous freezing during walking and turning freezing on encountering obstacle will be investigated in fMRI study to examine whether different regions of brain will be involved under different conditions of freezing. We hypothesize that anterior cortical regions will engage in gait ignition failure, deep locomotion regions will be responsible for spontaneous freezing and schema regions will be involved in the generation of turning freezing on seeing the barrier. In the third part of the project, we will deliver a 5-day session of transcranial direct current stimulation (tDCS) to the motor cortex of the FOG patients to examine whether the intervention will benefit the patients. Based on the signal source findings, we will investigate whether the possible tDCS beneficial effect will be different or similar in patients with different electric sources. In addition, how long the possible beneficial effect of tDCS can be consolidated after the 5-day course of stimulation is crucial and requires to be elucidated under the research project. We aim to peep the myth of FOG in PD by the multi-modality approach and hope the study will benefit the long suffering patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: October 31, 2018
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

The diagnosis of freezing of gait will be made by the following criteria:

1. Without video:Is there any feeling that your feet are transiently glued to the floor while trying to initiate walking, making a turn or when walking through narrow spaces or in crowded places? (Sometimes it can be accompanied with trembling of the legs and small shuffling steps.)

2. Additional instructions with video:We will watch a short video together to see the many ways in which freezing can occur. Also, look carefully for how long these episodes last, as you can expect some questions on this later.

3. Patient is diagnosed to have freezing of gait if "I have experienced such a feeling or episode over the past month" was answered.

Exclusion Criteria:

1. Impairment of cognition that leads unable to fully cooperate with the oral commands during examinations.

2. Moderate to severe medical disorders such as functional III or above congestive heart failure, or cancer with distant metastasis etc.

3. Hoehn and Yahr stage 5.

Related Conditions & MeSH terms

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

Intervention

Device:
• Transcranial direct current stimulation
A consecutive 5-days course of tDCS will be delivered. In treatment group, true stimulation will be administrated and sham stimulation will be delivered in control group.

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) after the tDCS session		baseline to week 4
Other	Change in non-motor symptom assessment scale for Parkinson's Disease after the tDCS		baseline to week 4
Other	Change in Fall assessment test after the tDCS session		baseline to week 4
Other	Change in new freezing of gait questionnaire(NFOG-Q) after the tDCS session		baseline to week 4
Other	Change in Tinetti's Mobility Index after the tDCS session		baseline to week 4
Primary	Change in laboratory gait analysis after the tDCS session	Variables in gait analysis:1.Gait initiation, 2.Level walking, 3.Turning, 4.Gait termination	baseline to week 4
Secondary	Change in Unified Parkinson's Disease Rating Scale (UPDRS) after the tDCS session		baseline to week 4