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

Parkinson Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06324448
• Other study ID #: PD-tDCS-RCT
• Status: Recruiting
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: February 28, 2025

Study information

• Verified date: March 2024
• Source: Seoul National University Hospital
• Contact: Han Gil Seo, PhD
• Phone: 82-2-2072-1659
• Email: hgseo80[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: February 28, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

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)).

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Timed-up and go test (sec)		Immediate post-intervention
Primary	Timed-up and go test under dual-task condition (sec)		Immediate post-intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	Single-leg stance test		Immediate post-intervention
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Timed-up and go test (sec)		Follow-up (1 month)
Secondary	Timed-up and go test under dual-task condition (sec)		Follow-up (1 month)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	Single-leg stance test		Follow-up (1 month)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)