Application of Transcranial Direct Current Stimulation (tDCS) for Gait Function Improvement of Parkinson's Disease Patient

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04591236
• Other study ID #: 2020-09-093
• Status: Completed
• Phase: N/A
• Start date: November 3, 2020
• Est. completion date: June 18, 2021

Study information

• Verified date: February 2023
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: June 18, 2021
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Device:
• Brain stimulation
tDCS brain stimulation on leg motor areas was applied to Parkinson patients.
• Treadmill gait training
Treadmill gait training was applied to Parkinson patients.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in 10 meter walk test from baseline in gait speed	Measure of self selected speeds by measuring the time it takes an individual to walk 10 meters. To perform the test, patient walks 10 meters (33 ft) and the time is measured when the leading foot crosses the start line and the finish line. The instructions are: "Please walk this distance at your normal pace when I say go."	session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Secondary	Change in Berg Balance Scale (BBS) from baseline in balance	Mesure of blance function. A five-point ordinal scale, ranging from 0-4. "0" indicates the lowest level of function and "4" the highest level of function. Score the LOWEST performance. Total Score = 56.	session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Secondary	Change in Timed Up and Go test (TUG) from baseline in balance	Meserue of dynamic blance function. 11-20 seconds are within normal limits for frail elderly and disabled patients, and greater than 20 seconds means the person needs assistance outside and indicates further examination and intervention. A score of 30 seconds or more suggests that the person may be prone to falls.	session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Secondary	Changes in Brain activation of resting-state functional MRI	Meserue of Neuroplasticity	session 0 (initial visit); session 10 (at approximately 4 weeks)
Secondary	Changes in motor evoked potentia	Measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle and TA muscle.	session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Secondary	Changes in Functional Reach Test (FRT) from baseline	FRT is a single item test developed as a quick screen for balance problems. Measurement Interpretation: 10"/25 cm or greater Low risk of falls; 6"/15cm to 10"/25cm Risk of falling is 2x greater than normal; 6"/15cm or less Risk of falling is 4x greater than normal; Unwilling to reach Risk of falling is 8x greater than normal	session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Secondary	Change in muscle manual test (MMT) and range of motion (ROM) from baseline	Meserue of MMT and ROM of lower extremity.	session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Secondary	Change in Unified Parkinson's Disease Rating Scale (UPDRS) from baseline	Meserue of Parkinson disease motor level.; 1) nonmotor experiences of daily living (13 items), (2) motor experiences of daily living (13 items), (3) motor examination (18 items), and (4) motor complications (six items). Each subscale now has 0-4 ratings, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.	session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Secondary	Change in Korean Mini-Mental State Examination (K-MMSE) from baseline	Meserue of cognition level. Any score of 24 or more (out of 30) indicates a normal cognition. Below this, scores can indicate severe (=9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment. The raw score may also need to be corrected for educational attainment and age.	session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Secondary	Change in Geriatric Depression Scale (GDS) from baseline	Meserue of depression. The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".	session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]