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

Primary Purpose

Parkinson's Disease With Freezing of Gait

Status

Unknown status

Phase

Not Applicable

Locations

Taiwan

Study Type

Interventional

Intervention

Transcranial direct current stimulation

About this trial

This is an interventional treatment trial for Parkinson's Disease With Freezing of Gait focused on measuring Parkinson's disease, freezing of gait, electrophysiology, magnetic resonance image, direct current stimulation

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

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.)
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.
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:

Impairment of cognition that leads unable to fully cooperate with the oral commands during examinations.
Moderate to severe medical disorders such as functional III or above congestive heart failure, or cancer with distant metastasis etc.
Hoehn and Yahr stage 5.

Sites / Locations

China Medical University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

real tDCS

sham tDCS

Arm Description

Device: Transcranial direct current stimulation In tDCS,the anodal pad was tapped over the primary motor cortex and the cathode pad was adhered of the contralateral frontal region. A constant current of 2.0 mA will be apply for up to 20 min, with a linear fade in /fade out of 10 s in anodal and cathodal conditions resulting in a current density of 0.8A/M2 which is 177 times below the lesion effect of tDCS in the rats study(142.9A/m2)

Device: Sham tDCS Sham stimulation will be 30s stimulation with ramp up and ramp off for 10s at 2.0 mA.

Outcomes

Primary Outcome Measures

Change in laboratory gait analysis after the tDCS session

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 the tDCS session

Full Information

NCT ID

NCT03127475

First Posted

April 18, 2017

Last Updated

September 17, 2018

Sponsor

China Medical University Hospital

Collaborators

Ministry of Science and Technology, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT03127475

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 1, 2016 (Actual)

Primary Completion Date

July 31, 2017 (Actual)

Study Completion Date

October 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

China Medical University Hospital

Collaborators

Ministry of Science and Technology, Taiwan

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Parkinson's Disease With Freezing of Gait

Keywords

Parkinson's disease, freezing of gait, electrophysiology, magnetic resonance image, direct current stimulation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

real tDCS

Arm Type

Experimental

Arm Description

Arm Title

sham tDCS

Arm Type

Sham Comparator

Arm Description

Device: Sham tDCS Sham stimulation will be 30s stimulation with ramp up and ramp off for 10s at 2.0 mA.

Intervention Type

Device

Intervention Name(s)

Transcranial direct current stimulation

Intervention Description

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.

Primary Outcome Measure Information:

Title

Change in laboratory gait analysis after the tDCS session

Description

Variables in gait analysis:1.Gait initiation, 2.Level walking, 3.Turning, 4.Gait termination

Time Frame

baseline to week 4

Secondary Outcome Measure Information:

Title

Change in Unified Parkinson's Disease Rating Scale (UPDRS) after the tDCS session

Time Frame

baseline to week 4

Other Pre-specified Outcome Measures:

Title

Change in the 39-item Parkinson's Disease Questionnaire (PDQ-39) after the tDCS session

Time Frame

baseline to week 4

Title

Change in non-motor symptom assessment scale for Parkinson's Disease after the tDCS

Time Frame

baseline to week 4

Title

Change in Fall assessment test after the tDCS session

Time Frame

baseline to week 4

Title

Change in new freezing of gait questionnaire(NFOG-Q) after the tDCS session

Time Frame

baseline to week 4

Title

Change in Tinetti's Mobility Index after the tDCS session

Time Frame

baseline to week 4

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: The diagnosis of freezing of gait will be made by the following criteria: 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.) 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. 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: Impairment of cognition that leads unable to fully cooperate with the oral commands during examinations. Moderate to severe medical disorders such as functional III or above congestive heart failure, or cancer with distant metastasis etc. Hoehn and Yahr stage 5.

Facility Information:

Facility Name

China Medical University Hospital

City

Taichung

ZIP/Postal Code

40447

Country

Taiwan

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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

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