Clinical trial NCT04504422: tDCS for Dual-task Performance in Patients With PD
Official title: Transcranial Direct Current Stimulation to Improve Dual-task Performance in Idiopathic Parkinson's Disease: A Prospective, Single-center, Double-blind, Explorative Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson Disease
transcranial direct current stimulation
dual-task performance
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 24
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the optimal stimulation location of transcranial direct current stimulation to improve the dual-task performance 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. Walking performance in a dual-task condition has been used to assess gait automaticity in patients with Parkinson's disease.

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 function. However, few studies have reported the therapeutic effect of tDCS on the dual-task performance in PD. In addition, inconsistent results have been reported because tDCS protocol has been applied in various way. Therefore, this study aims to investigate an optimized stimulation site of tDCS that could improve the dual-task performance in patients with PD.

Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed as idiopathic Parkinson's disease
* 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
* Sensory abnormalities of the lower extremities, other neurological or orthopedic disease affecting lower extremities, or severe cardiovascular diseases
* Vestibular disease or paroxysmal vertigo
* Pregnant or lactating patients
* Other comorbidities that make it difficult to participate in this study

Primary outcomes:
measure: Cognitive dual-task interference (%) in Timed-up & go test
timeFrame: Immediately after a 20-minute tDCS session
measure: Physical dual-task interference (%) in Timed-up & go test
timeFrame: Immediately after a 20-minute tDCS session
Secondary outcomes:
measure: Timed-up & go test (sec): single task
timeFrame: Immediately after a 20-minute tDCS session
measure: Timed-up & go test (sec): cognitive dual-task
timeFrame: Immediately after a 20-minute tDCS session
measure: Timed-up & go test (sec): physical dual-task
timeFrame: Immediately after a 20-minute tDCS session
measure: Stroop test
timeFrame: Immediately after a 20-minute tDCS session
measure: Trail making test
timeFrame: Immediately after a 20-minute tDCS session
measure: Digit span test
timeFrame: Immediately after a 20-minute tDCS session
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Han Gil Seo, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: