Parkinson DiseaseNCT04591236
Application of Transcranial Direct Current Stimulation (tDCS) for Gait Function Improvement of Parkinson's Disease Patient
A study testing Brain stimulation and Treadmill gait training in people with Parkinson Disease, run by Samsung Medical Center at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Brain stimulation and Treadmill gait training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Nov 2020to 18 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 50 - 75 years
- Modified Hoehn and Yahr stages 1 to 4
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Parkinson Disease
- Being tested
- Brain stimulation, Treadmill gait training
- Keywords
- transcranial direct current stimulation, gait training, Parkinson's disease
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain stimulationDevice
tDCS brain stimulation on leg motor areas was applied to Parkinson patients.
Treadmill gait trainingDevice
Treadmill gait training was applied to Parkinson patients.
| Study group | Role | What they receive |
|---|---|---|
| Gait training with brain stimulation | Experimental | Treadmill gait training and transcranial direct current stimulation (tDCS) on the leg motor areas Receives: Device: Brain stimulation; Device: Treadmill gait training |
| Gait training with sham brain stimulation | Active comparator | Treadmill gait training and anodal sham transcranial direct current stimulation (tDCS) on the leg motor areas Receives: Device: Treadmill gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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."
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Secondary outcomes (9)
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.
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
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.
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Changes in Brain activation of resting-state functional MRI
Meserue of Neuroplasticity
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks)
Changes in motor evoked potentia
Measure the motor threshold and amplitude of motor evoked potential in first dorsal interosseous muscle and TA muscle.
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
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
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Change in muscle manual test (MMT) and range of motion (ROM) from baseline
Meserue of MMT and ROM of lower extremity.
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Change in Unified Parkinson's Disease Rating Scale (UPDRS) from baseline
Meserue of Parkinson disease motor level.
- 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.
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
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.
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
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".
Measured: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start3 Nov 2020
- Primary completion31 May 2021
- Study completion18 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yun-Hee Kim, Samsung Medical Center
- Investigators
- Yun-Hee Lee, Ph.D, Principal investigator, yun1225.kim@samsung.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04591236
- Sponsor's protocol ID
- 2020-09-093
- Status last verified
- Feb 2023
- First submitted
- 15 Oct 2020
- Last updated
- 1 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04591236
- Acronym / sponsor ID
- 2020-09-093
- Conditions
- Parkinson Disease
- Keywords
- transcranial direct current stimulation, gait training, Parkinson's disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 3 Nov 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 18 Jun 2021 (actual)
- First posted
- 19 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gait training with brain stimulation | Experimental | Device: Brain stimulation, Device: Treadmill gait trainingTreadmill gait training and transcranial direct current stimulation (tDCS) on the leg motor areas |
| Gait training with sham brain stimulation | Active comparator | Device: Treadmill gait trainingTreadmill gait training and anodal sham transcranial direct current stimulation (tDCS) on the leg motor areas |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age: 50 - 75 years
- Modified Hoehn and Yahr stages 1 to 4
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brain stimulationtDCS brain stimulation on leg motor areas was applied to Parkinson patients. | Device | Gait training with brain stimulation |
| Treadmill gait trainingTreadmill gait training was applied to Parkinson patients. | Device | Gait training with brain stimulation, Gait training with sham brain stimulation |
Primary outcome
Change in 10 meter walk test from baseline in gait speed
Time frame: 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."
9 secondary outcomes
Change in Berg Balance Scale (BBS) from baseline in balance
Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Change in Timed Up and Go test (TUG) from baseline in balance
Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Changes in Brain activation of resting-state functional MRI
Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks)
Changes in motor evoked potentia
Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Changes in Functional Reach Test (FRT) from baseline
Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Change in muscle manual test (MMT) and range of motion (ROM) from baseline
Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Change in Unified Parkinson's Disease Rating Scale (UPDRS) from baseline
Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Change in Korean Mini-Mental State Examination (K-MMSE) from baseline
Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Change in Geriatric Depression Scale (GDS) from baseline
Time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun-Hee Lee, Ph.D principal investigator
yun1225.kim@samsung.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Brain stimulation and Treadmill gait training in people with Parkinson Disease, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in 10 meter walk test from baseline in gait speed (time frame: session 0 (initial visit); session 10 (at approximately 4 weeks); after 4 weeks from intervention termination (follow-up)]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Mar 2023.