Self-administered tDCS for Improving Single- and Dual-task Gait in Patients With PD
- Conditions
- Parkinson Disease
- Interventions
- Device: Transcranial direct current stimulation
- Registration Number
- NCT06324448
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
- Clinically diagnosed as idiopathic Parkinson's disease by neurologists according to the UK Parkinson's Disease Society Brain Bank criteria
- modified Hoehn & Yahr stage 2, 2.5, or 3
- History of seizure
- Metallic implants, such as cardiac pacemaker or an artificial cochlea
- Patients with inflammation, burns, or wounds in the stimulation area
- Parkinson's disease dementia; cut-off is < 7 of Korean-Montreal Cognitive Assessment for illiterate patients, < 13 for those educated for 0.5-3 years, < 16 for 4-6 years of education, < 19 for 7-9 years of education, and < 20 for 10 or more years of education.
- Severe dyskinesia or severe on-off phenomenon
- Plan to adjust medication at the time of screening
- Other neurological, orthopedic, or cardiovascular co-morbidities significantly affecting gait function
- Uncontrolled vestibular disease, orthopedic hypotension, or paroxysmal vertigo
- Pregnant or lactating patients
- Other comorbidities that make it difficult to participate in this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Primary motor cortex Transcranial direct current stimulation The anodal electrode is positioned in the primary motor cortex (Cz) and the cathodal electrode on the right orbital frontal cortex (Fp2). The current increases to 2.0 mA over a period of 30 seconds, maintains 2.0 mA for 19 minutes, and decreases to 0 mA over 30 seconds. Left dorsolateral prefrontal cortex Transcranial direct current stimulation The anodal electrode is positioned in the left dorsolateral prefrontal cortex (F3) and the cathodal electrode on the right orbital frontal cortex (Fp2). The current increases to 2.0 mA over a period of 30 seconds, maintains 2.0 mA for 19 minutes, and decreases to 0 mA over 30 seconds.
- Primary Outcome Measures
Name Time Method Timed-up and go test under dual-task condition (sec) Immediate post-intervention Timed-up and go test (sec) Immediate post-intervention
- Secondary Outcome Measures
Name Time Method modified Attention Allocation Index (mAAI) in Timed-up and go test Follow-up (1 month) modified Attention Allocation Index (mAAI)=motor dual task effect(mDTE)-cognitive dual task effect (cogDTE)
Trail making test Follow-up (1 month) The trail-making test is a neuropsychological measure that assesses psychomotor speed, attention, sequencing, mental flexibility, and visual scanning.
Stroop test 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.
Timed-up and go test (sec) Follow-up (1 month) Dual-task effect (%) in Timed-up and go test Follow-up (1 month) Percentage of dual-task effect calculated by the difference between dual-task and single-task performance \[Percentage of dual-task interference=(Dual-task performance - Single-task performance)/Single-task performance\]
Single-leg stance test Follow-up (1 month) New freezing of gait questionnaire (NFoGQ) Follow-up (1 month) NFoGQ consists of 6 items. Total score ranges from 0 to 24. the higher scores, the more negative results.
Geriatric depression scale (GDS)-short form Follow-up (1 month) The GDS Short Form contains 15 items. The higher the score, the more negative the result.
Gait parameters 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
Timed-up and go test under dual-task condition (sec) Follow-up (1 month)
Trial Locations
- Locations (1)
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of