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

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Device: Brain stimulation; Device: Treadmill gait training

• Registration Number: NCT04591236
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-15
• Study First Posted: 2020-10-19
• Study Start: 2020-11-03
• Primary Completion: 2021-05-31
• Study Completion: 2021-06-18
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-27
• Last Update Posted: 2023-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gait training with brain stimulation	Brain stimulation	Treadmill gait training and transcranial direct current stimulation (tDCS) on the leg motor areas
Gait training with brain stimulation	Treadmill gait training	Treadmill gait training and transcranial direct current stimulation (tDCS) on the leg motor areas
Gait training with sham brain stimulation	Treadmill gait training	Treadmill gait training and anodal sham transcranial direct current stimulation (tDCS) on the leg motor areas

Primary Outcome Measures

Name	Time	Method
Change in 10 meter walk test from baseline in gait speed	session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]	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."

Secondary Outcome Measures

Name	Time	Method
Change in Berg Balance Scale (BBS) from baseline in balance	session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]	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.
Change in Timed Up and Go test (TUG) from baseline in balance	session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]	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.
Changes in Brain activation of resting-state functional MRI	session 0 (initial visit); session 10 (at approximately 4 weeks)	Meserue of Neuroplasticity
Changes in motor evoked potentia	session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]	Measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle and TA muscle.
Changes in Functional Reach Test (FRT) from baseline	session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]	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
Change in muscle manual test (MMT) and range of motion (ROM) from baseline	session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]	Meserue of MMT and ROM of lower extremity.
Change in Unified Parkinson's Disease Rating Scale (UPDRS) from baseline	session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]	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.
Change in Korean Mini-Mental State Examination (K-MMSE) from baseline	session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]	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.
Change in Geriatric Depression Scale (GDS) from baseline	session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]	Meserue of depression. The grid sets a range of 0-9 as "normal", 10-19 as "mildly depressed", and 20-30 as "severely depressed".

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of