Self-administered tDCS for Improving Single- and Dual-task Gait in Patients With PD

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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Device: Transcranial direct current stimulation

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.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Han Gil Seo, PhD; Phone Number: 82-2-2072-1659; Email: hgseo80@gmail.com
• Study Contact Backup: Name: Seo Jung Yun, MS; Phone Number: 82-2-2072-1659; Email: seojungyun@snu.ac.kr

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Recruiting
    • Seoul National University Hospital
    • Contact: Han Gil Seo, MD; Phone Number: 82-2-2072-1659; Email: hgseo80@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Primary motor cortex; 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.	Device: Transcranial direct current stimulation; 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)).
Experimental: Left dorsolateral prefrontal cortex; 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.	Device: Transcranial direct current stimulation; 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)).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Timed-up and go test (sec)	Immediate post-intervention
Timed-up and go test under dual-task condition (sec)	Immediate post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]	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)	Immediate post-intervention
Single-leg stance test		Immediate post-intervention
Timed-up and go test (sec)		Follow-up (1 month)
Timed-up and go test under dual-task condition (sec)		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]	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)	Follow-up (1 month)
Single-leg stance test		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	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.	Immediate post-intervention
Trail making test	The trail-making test is a neuropsychological measure that assesses psychomotor speed, attention, sequencing, mental flexibility, and visual scanning.	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.	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.	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	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.	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.	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.	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.	Follow-up (1 month)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2024
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 28, 2025

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 19, 2024
• First Posted (Actual): March 22, 2024

Study Record Updates

• Last Update Posted (Actual): March 26, 2024
• Last Update Submitted That Met QC Criteria: March 23, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: transcranial direct current stimulation; gait; Parkinson Disease; dual-task
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: PD-tDCS-RCT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No