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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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ClinicalTrials.gov Identifier: NCT03721887
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : October 26, 2018
Sponsor:
Collaborator:
Ministry of Science and Technology, Taiwan
Information provided by (Responsible Party):
Chon-Haw Tsai, China Medical University Hospital

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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Multiple System Atrophy Device: Transcranial direct current stimulation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2021


Arm Intervention/treatment
Experimental: real tDCS
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.
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.

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




Primary Outcome Measures :
  1. EEG recording before and after the tDCS session [ Time Frame: baseline to week 4 ]
    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 :
  1. Electromyography recording before and after the tDCS session [ Time Frame: baseline to week 4 ]
    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.

  2. Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III before and after the tDCS session [ Time Frame: baseline to week 4 ]
    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.

  3. Change in Unified Multiple System Atrophy Rating Scale (UMSARS) subscores (UMSARS-1 and UMSARS-2) before and after the tDCS session [ Time Frame: baseline to week 4 ]
    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.


Other Outcome Measures:
  1. Change in New freezing of gait questionnaire (NFOG-Q) before and after the tDCS session [ Time Frame: baseline to week 4 ]
    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.

  2. Change in Tinetti's Mobility Index total score before and after the tDCS session [ Time Frame: baseline to week 4 ]
    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.

  3. Change inParkinson's Disease Questionnaire 39 (PDQ-39) before and after the tDCS session [ Time Frame: baseline to week 4 ]
    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.

  4. Change in Short Form 36 Health Survey (SF-36) total score before and after the tDCS session [ Time Frame: baseline to week 4 ]
    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.



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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03721887


Locations
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Taiwan
China Medical University Hospital Recruiting
Taichung, Taiwan, 40447
Contact: Chon-Haw Tsai, PHD    8864-22052121 ext 2003    d8079@mail.cmuh.org.tw   
Sponsors and Collaborators
China Medical University Hospital
Ministry of Science and Technology, Taiwan

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Responsible Party: Chon-Haw Tsai, The chief, Department of Neurology, China Medical University Hospital
ClinicalTrials.gov Identifier: NCT03721887     History of Changes
Other Study ID Numbers: CMUH106-REC2-171
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chon-Haw Tsai, China Medical University Hospital:
Parkinson's disease
Multiple system atrophy
Freezing of gait
Transcranial direct current stimulation

Additional relevant MeSH terms:
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Parkinson Disease
Atrophy
Multiple System Atrophy
Shy-Drager Syndrome
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Pathological Conditions, Anatomical
Primary Dysautonomias
Autonomic Nervous System Diseases
Hypotension
Vascular Diseases
Cardiovascular Diseases