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临床试验/NCT06818240
NCT06818240招募中不适用

Transcranial Direct Current Stimulation of the Dorsolateral Prefrontal Cortex Enhances Dual-task Performance in People with Stroke

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
Stride length

研究概览

简要总结

Stroke often impairs lower limb control, resulting in gait abnormalities and difficulties in dual-task performance, such as walking while engaging in cognitive activities. This study examines the effects of a single session of transcranial direct current stimulation (tDCS) targeting the left dorsolateral prefrontal cortex (DLPFC) on dual-task walking performance in individuals with chronic stroke. Using a cross-over design, participants will undergo two sessions (active or sham tDCS, 7 ± 2 days apart) of stimulation at 2 mA for 30 minutes. Walking performance will be measured using single and dual-task conditions combining motor (e.g., 20 m walk) and cognitive tasks (e.g., word association, random number recall). Primary outcomes include walking speed (m/s), stride length (m), and dual-task cost (DTC) for mobility and cognitive speed.

The study aims to evaluate tDCS as a potential tool to reduce DTC, improve dual-task performance, and improve daily function and quality of life in stroke survivors. Results may guide the development of tailored dual-task interventions in stroke rehabilitation.

详细描述

Stroke often results in impaired control of lower limb movement, leading to abnormal gait patterns. During daily activities, walking in the community typically involves performing additional cognitive tasks simultaneously, such as remembering directions or engaging in social interactions. Individuals with stroke are particularly susceptible to dual-task interference and demonstrate a slower gait speed, decreased walking adaptability (e.g., obstacle avoidance), and poorer cognitive task performance during dual-task walking, which can increase the dual-task cost (DTC). Transcranial Direct Current Stimulation (tDCS) is a potential tool to reduce DTC, leading to behavioral modifications and improved cognitive functions. This study aims to investigate the effects of a single session of tDCS targeting the left dorsolateral prefrontal cortex (DLPFC) on dual-task walking performance in individuals with chronic stroke.

The study will be a repeated measure designed with two testing sessions (same time in a day, 7 ± 2 days apart between sessions). People with stroke fulfilling the inclusion and exclusion criteria will be recruited from the local community. In each session, active or shame tDCS will be administered first, followed immediately by randomly assigned single and dual tasks. The stimulation will be delivered using a current stimulator (DC-STIMULATOR MOBILE, NeuroConn, Germany). The intensity is set at 2 mA for 30 min. The anode will be placed over the left DLPFC (F3 according to the EEG 10/20 system), while the cathode over the contralateral supraorbital ridge. The gait measurement is recorded by the Opal IMU sensor module and MobilityLab system (APDM Inc., USA).

Measurements of mobility will consist of two walking conditions: single-task and dual-task walking. For the walking test, we perform 'Stand and Walk for a 20-meter Round Trip (10 meters each way)(SWR), which consists of standing for 10 s, walking 10 m, turning, and walking 10 m back. The total time (TT) taken to complete one SWR test will be recorded. For the single cognitive tasks, participants will remain seated and perform the following: Random number, Word association, Counting forward, Serial subtraction. The time taken to complete each task will be equivalent to the TT recorded during the SSWR test. Additionally, the number of correct responses and errors made during the cognitive tasks will be recorded for further analysis. For the dual tasks, we will combine motor and cognitive tasks to assess dual-task performance. The specific dual tasks include SWR + Random Number, SWR + Word Association, SWR + Counting Forward, SWR + Serial Subtraction, SWR + Head Turns, and SWR+ Visual Fixation. The time taken to complete each task and the number of correct responses and errors made will be recorded for further analysis.

The primary outcomes include gait speed (m/s), stride length (m), and dual-task costs (DTC) for mobility and cognition speed. Each session will last approximately 60 min, including both tDCS and MobilityLab setup, and rest.

The findings may provide valuable insights into the use of tDCS as an adjunctive treatment for stroke patients. By enhancing the cortical activity of the left DLPFC through tDCS, it is anticipated that the dual-task cost would be reduced, which results in better dual-task performance and an improvement in daily function and overall quality of life for stroke survivors.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •age between 50 and 80 years
  • •at least 6 months post-first-ever stroke with unilateral motor deficits
  • •ability to walk independently for at least 10 m without the use of walking aids
  • •a score of 24 or higher on the Mini-Mental State Examination (MMSE)

排除标准

  • •unstable medical conditions, such as heart failure, uncontrolled hypertension, or cancer
  • •presence of other comorbidities that could interfere with gait
  • •history of contraindications to tDCS, such as epilepsy or metal implants
  • •history of head injury, head surgery, or lower limb orthopedic issues

研究组 & 干预措施

A constant current of 2 mA was applied for 30 minutes

Active Comparator

In the active tDCS session, a constant current of 2 mA was applied for 30 minutes, with a 30-second ramp-up and ramp-down for comfort.

干预措施: Active transcranial direct current stimulation (Device)

no active current was applied throughout the stimulation phase

Sham Comparator

For the sham condition, no active current was applied throughout the stimulation phase, except for an electrical current of 1 mA, which was delivered for the first and last 60 seconds, with similar ramping to control for potential sensation bias.

干预措施: Sham transcranial direct current stimulation (Device)

结局指标

主要结局

Stride length

时间窗: Immediately after the active/sham tDCS intervention

Kinematic data will be collected using a motion tracking system, the MobilityLab system (APDM Inc., Portland, OR, USA), and the Opal IMU sensor module (with 128 Hz sampling frequency). A total of eight sensors will be affixed using velcro belts, positioned on the sternum of the upper body, at the lumbar region, and on pairs of upper legs, lower legs, and feet. Stride length (m) will be recorded during each walking task.

Cognitive response rate

时间窗: Immediately after the active/sham tDCS intervention

Cognitive performance will be evaluated during each task by the number of correct words per second, defined as the response rate (correct responses/second).

DTC- Cognitive speed

时间窗: Immediately after the active/sham tDCS intervention

The impact of dual-tasking will be quantified by calculating the dual-task cost (DTC) using the following formula: DTC (%) = (dual task outcome measure-single task outcome measure)/single task outcome measure × 100. For example, DTC-time reflects the variation in time taken to complete the SWR test under dual-task versus single-task conditions. DTC- Cognitive speed represents the variation in response rate under both conditions.

Gait speed

时间窗: Immediately after the active/sham tDCS intervention

Kinematic data will be collected using a motion tracking system, the MobilityLab system (APDM Inc., Portland, OR, USA), and the Opal IMU sensor module (with 128 Hz sampling frequency). A total of eight sensors will be attached with Velcro straps to the sternum of the upper body, the lumbar region, and pairs of thighs, lower legs, and feet. The walking speed (m/s) will be recorded during each walking task.

DTC- Mobility speed

时间窗: Immediately after the active/sham tDCS intervention

The impact of dual-tasking will be quantified by calculating the dual-task cost (DTC) using the following formula: DTC (%) = (dual task outcome measure-single task outcome measure)/single task outcome measure × 100. DTC-mobility speed indicates the variation in speed used under dual-task versus single-task conditions.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shamay Ng

Prof.

The Hong Kong Polytechnic University

研究点 (1)

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