Clinical trial NCT06324448: Self-administered tDCS for Improving Single- and Dual-task Gait in Patients With PD
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
transcranial direct current stimulation
gait
dual-task
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-03-22
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled trial
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Timed-up and go test (sec)
timeFrame: Immediate post-intervention
measure: Timed-up and go test under dual-task condition (sec)
timeFrame: Immediate post-intervention
Secondary outcomes:
measure: Dual-task effect (%) in Timed-up and go test
timeFrame: Immediate post-intervention
measure: modified Attention Allocation Index (mAAI) in Timed-up and go test
timeFrame: Immediate post-intervention
measure: Gait parameters
timeFrame: Immediate post-intervention
measure: Single-leg stance test
timeFrame: Immediate post-intervention
measure: Stroop test
timeFrame: Immediate post-intervention
measure: Trail making test
timeFrame: Immediate post-intervention
measure: New freezing of gait questionnaire (NFoGQ)
timeFrame: Immediate post-intervention
measure: Geriatric depression scale (GDS)-short form
timeFrame: Immediate post-intervention
measure: Timed-up and go test (sec)
timeFrame: Follow-up (1 month)
measure: Timed-up and go test under dual-task condition (sec)
timeFrame: Follow-up (1 month)
measure: Dual-task effect (%) in Timed-up and go test
timeFrame: Follow-up (1 month)
measure: modified Attention Allocation Index (mAAI) in Timed-up and go test
timeFrame: Follow-up (1 month)
measure: Gait parameters
timeFrame: Follow-up (1 month)
measure: Single-leg stance test
timeFrame: Follow-up (1 month)
measure: Stroop test
timeFrame: Follow-up (1 month)
measure: Trail making test
timeFrame: Follow-up (1 month)
measure: New freezing of gait questionnaire (NFoGQ)
timeFrame: Follow-up (1 month)
measure: Geriatric depression scale (GDS)-short form
timeFrame: Follow-up (1 month)
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: