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

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

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.

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

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

More Information

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

• 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:

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