tDCS for Dual-task Performance in Patients With PD

NCT04504422 | Completed DMC

• 1 other identifier: PD-tDCS-O
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; transcranial direct current stimulation; dual-task performance

Outcome Measures

Primary Outcomes (2)

• Cognitive dual-task interference (%) in Timed-up & go test

  Percentage of dual-task interference calculated by the difference between dual-task and single-task performance \[Percentage of dual-task interference=(Dual-task performance - Single-task performance)/Single-task performance\]

  Immediately after a 20-minute tDCS session

• Physical dual-task interference (%) in Timed-up & go test

  Percentage of dual-task interference calculated by the difference between dual-task and single-task performance \[Percentage of dual-task interference=(Dual-task performance - Single-task performance)/Single-task performance\]

  Immediately after a 20-minute tDCS session

Secondary Outcomes (6)

• Timed-up & go test (sec): single task

  Immediately after a 20-minute tDCS session

• Timed-up & go test (sec): cognitive dual-task

  Immediately after a 20-minute tDCS session

• Timed-up & go test (sec): physical dual-task

  Immediately after a 20-minute tDCS session

• Stroop test

  Immediately after a 20-minute tDCS session

• Trail making test

  Immediately after a 20-minute tDCS session

Study Arms (4)

Primary motor cortex

EXPERIMENTAL

The anodic electrode is positioned in the primary motor cortex (Cz) and the cathode 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)

Left dorsolateral prefrontal cortex

EXPERIMENTAL

The anodic electrode is positioned in the left dorsolateral prefrontal cortex (F3) and the cathode 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)

Ventromedial prefrontal cortex

EXPERIMENTAL

The anodic electrode is positioned in the ventromedial prefrontal cortex (Fpz) and the cathode electrode on the left dorsolateral prefrontal cortex (F4). 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)

Sham stimulation

SHAM COMPARATOR

The anodic electrode is positioned in the primary motor cortex (Cz) and the cathode electrode on the right orbital frontal cortex (Fp2). The current increases to 2.0 mA during first 30 seconds, decreases to 0 mA over 30 seconds, and then stops supplying for 19 minutes.

Device: transcranial Direct Current Stimulation (tDCS)

Interventions

transcranial Direct Current Stimulation (tDCS) DEVICE

tDCS was applied for 20 minutes through two saline-soaked sponge electrodes (diameter 6cm) using the YMS-201B (Ybrain Inc, South Korea).

Left dorsolateral prefrontal cortex; Primary motor cortex; Sham stimulation; Ventromedial prefrontal cortex

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinically diagnosed as idiopathic Parkinson's disease
• modified Hoehn \& Yahr stage 2, 2.5, or 3

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Han Gil Seo, MD, PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 5, 2020
• First Posted: August 7, 2020
• Study Start: November 5, 2020
• Primary Completion: February 13, 2024
• Study Completion: February 13, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

KR (1)