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Exploit the Neural Source and the Feasibility of Transcranial Direct Current Stimulation for Freezing of Gait in Parkinson's Disease and Multiple System Atrophy

Primary Purpose

Parkinson's Disease, Multiple System Atrophy

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Transcranial direct current stimulation
Sponsored by
China Medical University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson's Disease focused on measuring Parkinson's disease, Multiple system atrophy, Freezing of gait, Transcranial direct current stimulation

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Patients meet the diagnosis of PD41 or MSA43 based on the established consensus criteria
  2. Age above 30 years old and below 85 years

Exclusion Criteria:

  1. Impairment of cognition that leads unable to fully cooperate with the oral commands during examinations
  2. Functional III or above congestive heart failure, or cancer with distant metastasis
  3. Hoehn and Yahr stage 5 in PD or MSA

Sites / Locations

  • China Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

real tDCS

sham tDCS

Arm Description

In transcranial direct current stimulation, 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 mins.

In transcranial direct current stimulation, the sham stimulation will be 30s stimulation with ramp up and ramp off for 10s at 2.0 mA.

Outcomes

Primary Outcome Measures

EEG recording before and after the tDCS session
Gait recording by 64 channels EEG device. Four different frequency bands ( theta, alpha, beta, and gamma) will be investigated. Variables in gait analysis: 1.Gait initiation, 2.Level walking, 3.Gait termination.

Secondary Outcome Measures

Electromyography recording before and after the tDCS session
The 4 pairs of leg EMG recording during 50 meters walking. The EMG signals will be filtered with a band pass ranging from 0.05 to 70 Hz. Variables in gait analysis: 1.Gait initiation, 2.Level walking, 3.Gait termination.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III before and after the tDCS session
UPDRS contains four parts, the third part of which is reported in this outcome. Part III is clinician-scored monitored motor evaluation (14 questions, ranges from 0=normal to 4= Severe). The scoring of Part III varies between 0-56. The higher score indicates the worse motor function. Negative change from baseline values indicate improvement.
Change in Unified Multiple System Atrophy Rating Scale (UMSARS) subscores (UMSARS-1 and UMSARS-2) before and after the tDCS session
UMSARS contains four parts, the UMSARS-1 and UMSARS-2 are reported in this outcome. UMSARS-1 scores symptoms of neurological and autonomic dysfunction (12 questions). UMSARS-2 is motor examination (14 questions). All questions range from 0 (normal) to 4(extreme dysfunction). Higher scores mean greater the impairment. Negative change from baseline values indicate improvement.

Full Information

First Posted
September 17, 2018
Last Updated
October 25, 2018
Sponsor
China Medical University Hospital
Collaborators
Ministry of Science and Technology, Taiwan
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1. Study Identification

Unique Protocol Identification Number
NCT03721887
Brief Title
Exploit the Neural Source and the Feasibility of Transcranial Direct Current Stimulation for Freezing of Gait in Parkinson's Disease and Multiple System Atrophy
Official Title
Exploit the Neural Source and the Feasibility of Transcranial Direct Current Stimulation for Freezing of Gait in Parkinson's Disease and Multiple System Atrophy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2018 (Actual)
Primary Completion Date
July 31, 2020 (Anticipated)
Study Completion Date
July 31, 2021 (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
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
In this project, the investigators will deliver a 5-day session of transcranial direct current stimulation (tDCS) to the leg motor cortex of the FOG patients to examine whether the intervention will benefit the patients in a double blind randomized design. Six assessments with different combinations of clinical scaling, gait analysis, electrophysiological investigation and fMRI examinations before and after tDCS will be conducted. The treatment and placebo groups will be crossed over after one-month washout. The investigators 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 also crucial. The investigators aim to peep the myth of FOG in PD and MSA 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, Multiple System Atrophy
Keywords
Parkinson's disease, Multiple system atrophy, Freezing of gait, Transcranial 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
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
real tDCS
Arm Type
Experimental
Arm Description
In transcranial direct current stimulation, 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 mins.
Arm Title
sham tDCS
Arm Type
Sham Comparator
Arm Description
In transcranial direct current stimulation, the 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
EEG recording before and after the tDCS session
Description
Gait recording by 64 channels EEG device. Four different frequency bands ( theta, alpha, beta, and gamma) will be investigated. Variables in gait analysis: 1.Gait initiation, 2.Level walking, 3.Gait termination.
Time Frame
baseline to week 4
Secondary Outcome Measure Information:
Title
Electromyography recording before and after the tDCS session
Description
The 4 pairs of leg EMG recording during 50 meters walking. The EMG signals will be filtered with a band pass ranging from 0.05 to 70 Hz. Variables in gait analysis: 1.Gait initiation, 2.Level walking, 3.Gait termination.
Time Frame
baseline to week 4
Title
Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III before and after the tDCS session
Description
UPDRS contains four parts, the third part of which is reported in this outcome. Part III is clinician-scored monitored motor evaluation (14 questions, ranges from 0=normal to 4= Severe). The scoring of Part III varies between 0-56. The higher score indicates the worse motor function. Negative change from baseline values indicate improvement.
Time Frame
baseline to week 4
Title
Change in Unified Multiple System Atrophy Rating Scale (UMSARS) subscores (UMSARS-1 and UMSARS-2) before and after the tDCS session
Description
UMSARS contains four parts, the UMSARS-1 and UMSARS-2 are reported in this outcome. UMSARS-1 scores symptoms of neurological and autonomic dysfunction (12 questions). UMSARS-2 is motor examination (14 questions). All questions range from 0 (normal) to 4(extreme dysfunction). Higher scores mean greater the impairment. Negative change from baseline values indicate improvement.
Time Frame
baseline to week 4
Other Pre-specified Outcome Measures:
Title
Change in New freezing of gait questionnaire (NFOG-Q) before and after the tDCS session
Description
NFOG-Q contains three parts: in the first part, a video clip will be shown to the participants with PD and help to classify whether an individual is a freezer or non-freezer. The second and third part of the questionnaire is designed for freezers only. Par II (items 2-6, scores range between 0-19) assesses the severity of FOG according to the frequency and duration of the freezing episodes. Part III (items 7-9, scores range between 0-9) evaluates the impact of freezing on daily activities. The higher score indicates the worse freezing of gait. Negative change from baseline values indicate improvement.
Time Frame
baseline to week 4
Title
Change in Tinetti's Mobility Index total score before and after the tDCS session
Description
The Tinetti's Mobility Index contains two parts, Part I is Balance tests (9 questions, scores range between 0-16) and Part II is Gait tests (7 questions, scores range between 0-12). The scoring of this scale varies between 0 and 28 (< 19 high fall risk, 19-24 medium fall risk, 25-28 low fall risk). Negative change from baseline values indicate increased fall risk.
Time Frame
baseline to week 4
Title
Change inParkinson's Disease Questionnaire 39 (PDQ-39) before and after the tDCS session
Description
PDQ-39 is composed of 39 questions, divided into 8 parts: mobility, activities of daily living (ADLs), emotional well-being, stigma, social support, cognition, communication and physical discomfort. It assesses how often people affected by Parkinson's experience difficulties across 8 dimensions of daily living. All questions range from 0 to 4 (0=never, 4=always). The scoring of this scale varies between 0-156. Negative change from baseline values indicate better quality of life rating.
Time Frame
baseline to week 4
Title
Change in Short Form 36 Health Survey (SF-36) total score before and after the tDCS session
Description
SF-36 is composed of 36 questions, divided into 8 parts: Vitality, Physical functioning, Bodily pain, General health perceptions, Physical role functioning, Emotional role functioning, Social role functioning, Mental health. The scores are weighted sums of the questions in each section. Scores range from 0-100 (Lower scores = more disability, higher scores = less disability). Negative change from baseline values indicate worse quality of life rating.
Time Frame
baseline to week 4

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients meet the diagnosis of PD41 or MSA43 based on the established consensus criteria Age above 30 years old and below 85 years Exclusion Criteria: Impairment of cognition that leads unable to fully cooperate with the oral commands during examinations Functional III or above congestive heart failure, or cancer with distant metastasis Hoehn and Yahr stage 5 in PD or MSA
Facility Information:
Facility Name
China Medical University Hospital
City
Taichung
ZIP/Postal Code
40447
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chon-Haw Tsai, PHD
Phone
8864-22052121
Ext
2003
Email
d8079@mail.cmuh.org.tw

12. IPD Sharing Statement

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Exploit the Neural Source and the Feasibility of Transcranial Direct Current Stimulation for Freezing of Gait in Parkinson's Disease and Multiple System Atrophy

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