Seoul National University Hospital
Seoul, 03080, South Korea
NCT Number: NCT06324448
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.
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Notify Me19 year and older
All sexes
Interventional
Not applicable
Seoul, 03080, South Korea
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)).
Time frame: Immediate post-intervention
Time frame: Immediate post-intervention
Time frame: Immediate post-intervention
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)=motor dual task effect(mDTE)-cognitive dual task effect (cogDTE)
Time frame: Immediate post-intervention
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
Time frame: Immediate post-intervention
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
The trail-making test is a neuropsychological measure that assesses psychomotor speed, attention, sequencing, mental flexibility, and visual scanning.
Time frame: Immediate post-intervention
NFoGQ consists of 6 items. Total score ranges from 0 to 24. the higher scores, the more negative results.
Time frame: Immediate post-intervention
The GDS Short Form contains 15 items. The higher the score, the more negative the result.
Time frame: Follow-up (1 month)
Time frame: Follow-up (1 month)
Time frame: Follow-up (1 month)
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)=motor dual task effect(mDTE)-cognitive dual task effect (cogDTE)
Time frame: Follow-up (1 month)
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)
Time frame: Follow-up (1 month)
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)
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)
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)
The GDS Short Form contains 15 items. The higher the score, the more negative the result.
Seoul National University Hospital
Other
Self-administered Transcranial Direct Current Stimulation for Improving Single- and Dual-task Gait in Patients With Idiopathic Parkinson's Disease: A Prospective, Single-center, Double-blind, Exploratory, Randomized Controlled Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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