Clinical trial NCT03721887: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson's Disease
Multiple System Atrophy
Keywords: Parkinson's disease
Multiple system atrophy
Freezing of gait
Transcranial direct current stimulation
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
First posted: 2018-10-26
Enrollment: 40
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: EEG recording before and after the tDCS session
timeFrame: baseline to week 4
Secondary outcomes:
measure: Electromyography recording before and after the tDCS session
timeFrame: baseline to week 4
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) Part III before and after the tDCS session
timeFrame: baseline to week 4
measure: Change in Unified Multiple System Atrophy Rating Scale (UMSARS) subscores (UMSARS-1 and UMSARS-2) before and after the tDCS session
timeFrame: baseline to week 4
Other outcomes:
measure: Change in New freezing of gait questionnaire (NFOG-Q) before and after the tDCS session
timeFrame: baseline to week 4
measure: Change in Tinetti's Mobility Index total score before and after the tDCS session
timeFrame: baseline to week 4
measure: Change inParkinson's Disease Questionnaire 39 (PDQ-39) before and after the tDCS session
timeFrame: baseline to week 4
measure: Change in Short Form 36 Health Survey (SF-36) total score before and after the tDCS session
timeFrame: baseline to week 4
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: