The purpose of this study is to investigate the efficacy and safety of self-administered transcranial direct current stimulation to improve the single- and dual-task gait in patients with Parkinson's disease.
Parkinson's disease (PD) is a disease caused by dopamine deficiency in the striatum resulting from the loss of dopaminergic neuronal cells in the cerebral substantia. It is a progressive neurodegenerative disease characterized by motor symptoms including gait disturbance and balance instability. In the early stages of Parkinson's disease, dysfunction of the sensorimotor area of the basal ganglia typically occurs, leading to habitual control hurdles. Accordingly, cognitive efforts are required to perform habitual tasks such as walking, and the automaticity of walking is reduced. Dual-task performance involves a complex interplay of motor functions as well as cognitive functions such as attention and executive function. One way to potentially reduce the cost of dual-tasking and the negative effects of motor-cognitive interference is to consider improving the corresponding component, i.e., motor or cognitive function. Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method that can be used to change cortical activity. Recently, there has been growing attention on tDCS as an adjunct tool for rehabilitation. Several tDCS studies in patients with PD have reported the positive results of tDCS on motor and cognitive function. Most studies have examined changes before and after a single session of stimulation, with limited research verifying the cumulative and long-term effects of tDCS. Therefore, this study aims to investigate the efficacy and safety of self-administered transcranial direct current stimulation to improve the single- and dual-task gait in patients with PD.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
24
tDCS self-administered at home once a day for 28 consecutive days for a total of 28 sessions (one session consists of 20 minutes through two saline-soaked sponge electrodes (diameter 6cm) using the YMS-201B (Ybrain Inc, South Korea)).
Seoul National University Hospital
Seoul, Seoul, South Korea
RECRUITINGTimed-up and go test (sec)
Time frame: Immediate post-intervention
Timed-up and go test under dual-task condition (sec)
Time frame: Immediate post-intervention
Dual-task effect (%) in Timed-up and go test
Percentage of dual-task effect calculated by the difference between dual-task and single-task performance \[Percentage of dual-task interference=(Dual-task performance - Single-task performance)/Single-task performance\]
Time frame: Immediate post-intervention
modified Attention Allocation Index (mAAI) in Timed-up and go test
modified Attention Allocation Index (mAAI)=motor dual task effect(mDTE)-cognitive dual task effect (cogDTE)
Time frame: Immediate post-intervention
Gait parameters
Symmetric temporospatial parameters, Normal cadence, Decreased \& intolerable walking velocity, Normal step length differential, Normal step length on both sides, Normal stride length on both sides, Normal swing phase \& stance phase on both sides, Normal single support time \& double support time on both sides, Slightly widened base of support on both sides, Increased foot angle on right side
Time frame: Immediate post-intervention
Single-leg stance test
Time frame: Immediate post-intervention
Stroop test
The Stroop test evaluates attention, executive function, processing speed, and cognitive flexibility regarding an individual's ability to inhibit the habitual response.
Time frame: Immediate post-intervention
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Trail making test
The trail-making test is a neuropsychological measure that assesses psychomotor speed, attention, sequencing, mental flexibility, and visual scanning.
Time frame: Immediate post-intervention
New freezing of gait questionnaire (NFoGQ)
NFoGQ consists of 6 items. Total score ranges from 0 to 24. the higher scores, the more negative results.
Time frame: Immediate post-intervention
Geriatric depression scale (GDS)-short form
The GDS Short Form contains 15 items. The higher the score, the more negative the result.
Time frame: Immediate post-intervention
Timed-up and go test (sec)
Time frame: Follow-up (1 month)
Timed-up and go test under dual-task condition (sec)
Time frame: Follow-up (1 month)
Dual-task effect (%) in Timed-up and go test
Percentage of dual-task effect calculated by the difference between dual-task and single-task performance \[Percentage of dual-task interference=(Dual-task performance - Single-task performance)/Single-task performance\]
Time frame: Follow-up (1 month)
modified Attention Allocation Index (mAAI) in Timed-up and go test
modified Attention Allocation Index (mAAI)=motor dual task effect(mDTE)-cognitive dual task effect (cogDTE)
Time frame: Follow-up (1 month)
Gait parameters
Symmetric temporospatial parameters, Normal cadence, Decreased \& intolerable walking velocity, Normal step length differential, Normal step length on both sides, Normal stride length on both sides, Normal swing phase \& stance phase on both sides, Normal single support time \& double support time on both sides, Slightly widened base of support on both sides, Increased foot angle on right side
Time frame: Follow-up (1 month)
Single-leg stance test
Time frame: Follow-up (1 month)
Stroop test
The Stroop test evaluates attention, executive function, processing speed, and cognitive flexibility regarding an individual's ability to inhibit the habitual response.
Time frame: Follow-up (1 month)
Trail making test
The trail-making test is a neuropsychological measure that assesses psychomotor speed, attention, sequencing, mental flexibility, and visual scanning.
Time frame: Follow-up (1 month)
New freezing of gait questionnaire (NFoGQ)
NFoGQ consists of 6 items. Total score ranges from 0 to 24. the higher scores, the more negative results.
Time frame: Follow-up (1 month)
Geriatric depression scale (GDS)-short form
The GDS Short Form contains 15 items. The higher the score, the more negative the result.
Time frame: Follow-up (1 month)