Clinical trial NCT04591236: Application of Transcranial Direct Current Stimulation (tDCS) for Gait Function Improvement of Parkinson's Disease Patient
Official title: The Effect of Simultaneous Application of Transcranial Direct Current Stimulation (tDCS) and Gait Training for Parkinson's Disease Patients on Gait Function Improvement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: transcranial direct current stimulation
gait training
Parkinson's disease
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2020-10-19
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to investigate the effect of simultaneous application of transcranial direct current stimulation (tDCS) and treadmill gait training for gait function recovery in Parkinson's disease patients with gait impairment.


Eligibility criteria: Inclusion Criteria:

* Age: 50 - 75 years
* Modified Hoehn and Yahr stages 1 to 4

Exclusion Criteria:

* Serious cardiac conditions (hospitalization for myocardial infarction or heart surgery within 3 months, history of congestive heart failure, documented serious and unstable cardiac arrhythmias, hypertrophic cardiomyopathy, severe aortic stenosis, angina or dyspnea at rest or during activities of daily living)
* Difficult to understand experimental tasks because of extremely severe cognitive impairment (Korean-Mini-Mental State Examination, K-MMSE≤10)
* History of psychiatric disease
* Implanted objects that would contraindicate tDCS

Primary outcomes:
measure: Change in 10 meter walk test from baseline in gait speed
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Secondary outcomes:
measure: Change in Berg Balance Scale (BBS) from baseline in balance
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
measure: Change in Timed Up and Go test (TUG) from baseline in balance
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
measure: Changes in Brain activation of resting-state functional MRI
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks)
measure: Changes in motor evoked potentia
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
measure: Changes in Functional Reach Test (FRT) from baseline
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
measure: Change in muscle manual test (MMT) and range of motion (ROM) from baseline
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS) from baseline
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
measure: Change in Korean Mini-Mental State Examination (K-MMSE) from baseline
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
measure: Change in Geriatric Depression Scale (GDS) from baseline
timeFrame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: yun1225.kim@samsung.com
name: Yun-Hee Lee, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: