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Electrotactile Frequency, Amplitude, and Temporal Gap Discrimination in Young Adults, Older Adults, and Stroke Survivors (ESD-NR)

2026年6月17日 更新者:Hangue Park、Sungkyunkwan University

Assessment of Electrotactile Sensory Discrimination Across Young Adults, Older Adults, and Stroke Survivors for Neurorehabilitation Feedback Design

The purpose of this study is to evaluate and compare sensory discrimination ability for electrotactile stimulation among young adults, older adults, and patients with stroke. Participants will receive non-invasive electrotactile stimulation through electrodes attached to the skin of the upper limb, such as the fingertip, palm, elbow, or shoulder, depending on the stimulation condition. The study will assess discrimination thresholds for changes in stimulation frequency, stimulation amplitude, and temporal gaps in stimulation, together with task accuracy and reaction time. The results are expected to provide foundational data for sensory assessment, electrotactile feedback design, and sensory-based rehabilitation technologies for older adults and stroke patients.

研究概览

地位

尚未招聘

条件

详细说明

Accurate perception of sensory information is essential for movement control and interaction with the external environment. It is also important for providing precise feedback during motor rehabilitation. Aging and neurological injury, such as stroke, can affect tactile and proprioceptive information processing. These changes are important considerations when designing sensory-feedback-based rehabilitation approaches and assistive devices.

Electrotactile stimulation can be delivered non-invasively through the skin surface. By controlling stimulation frequency, amplitude, and temporal features, electrotactile stimulation can convey different types of tactile information. Because perception of electrotactile stimulation may vary according to individual sensory sensitivity, age, and neurological status, quantitative assessment of electrotactile information processing across participant groups is needed.

The just noticeable difference (JND) is a quantitative measure of the minimum detectable difference between stimuli. In this study, JND will be used to evaluate discrimination ability for electrotactile stimulation frequency, amplitude, and temporal gaps. Task accuracy and reaction time will also be analyzed to characterize sensory sensitivity, information processing, and response characteristics.

The study will include three participant groups: young adults, older adults, and stroke patients. Young and older adult participants will visit the laboratory on two consecutive days and perform electrotactile sensory discrimination tasks. Stroke patients will participate in a single study visit. Before the main experiment, stroke patients will undergo preliminary assessments of handedness, cognitive function, upper-limb motor function, proprioception, cutaneous sensation, and hand function.

For each participant, the stimulation range will be individualized based on sensory thresholds. The perception threshold (PT), defined as the voltage at which the participant first perceives electrotactile stimulation, and the discomfort threshold (DT), defined as the voltage at which the participant first begins to feel discomfort, will be measured. Stimulation amplitude used during the experimental tasks will be set within the range between PT and DT and will remain below DT. If a participant reports discomfort or pain during the experiment, stimulation will be stopped immediately.

Electrotactile stimulation will be provided using a voltage-limited and current-limited stimulator. The maximum applied voltage will be limited to 30 V, and the maximum allowable current will be limited to 10 mA as an additional safety limit. In practice, the expected current during stimulation is approximately 2 to 4 mA when electrodes are attached to the skin. The stimulation frequency used in this study will not exceed 100 Hz.

Participants will complete electrotactile frequency discrimination, amplitude discrimination, and temporal gap discrimination tasks. In the frequency discrimination task, a reference electrotactile stimulus and a comparison stimulus will be presented, and participants will report which stimulus is perceived as faster. In the amplitude discrimination task, two electrotactile stimuli with different amplitudes will be presented, and participants will report which stimulus is perceived as stronger. In the temporal gap discrimination task, participants will receive electrotactile stimulation containing brief temporal gaps, and their ability to detect short interruptions in stimulation will be evaluated.

For young and older adult participants, the study may also include a cognitive load condition. Participants will complete both a focused electrotactile discrimination condition and a cognitive load condition in which they perform a simple arithmetic task, such as serial subtraction by 7 from 100, while judging electrotactile stimuli. This condition will be used to evaluate the effect of cognitive load on sensory discrimination performance and to compare age-related differences. Stroke patients will not undergo the cognitive load condition in order to minimize fatigue and experimental burden and to ensure safe participation.

Before the main electrotactile discrimination experiment, stroke patients will undergo preliminary assessments to characterize baseline function. These assessments may include handedness assessment, Korean Mini-Mental State Examination (K-MMSE), Fugl-Meyer Assessment of the Upper Extremity (FMA-UE), Fugl-Meyer upper-limb position sense test, and sensory testing including sharp/blunt discrimination, temperature sensation, and monofilament sensory testing.

For stroke participants, clinical information related to stroke may be reviewed or collected only when the participant already has such materials and voluntarily provides them. These materials may include MRI or CT radiology reports, discharge summaries, medical opinion letters or diagnostic certificates, and MRI or CT image files on CD or USB. The information may be used to confirm stroke onset timing, lesion location, lesion size, lesion laterality, and radiological findings. Collected materials will be used only for research purposes. Personally identifiable information will be de-identified, securely stored for the required retention period according to relevant regulations, and then discarded after the study.

Participants will be monitored for discomfort, pain, skin redness, allergic reaction, dizziness, excessive fatigue, or other adverse symptoms during the experiment. If a participant expresses a wish to stop participation for any reason, or if severe discomfort occurs due to electrical stimulation, the experiment will be stopped immediately. After participation, participants will be monitored by questionnaire 3 days and 7 days after the experiment to assess whether skin allergic reactions, arm discomfort, or other symptoms occurred after participation.

研究类型

介入性

注册 (估计的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria:

  • Young Adult Group:
  • Age 19 to 54 years.
  • Has tactile sensation in the hands and fingers.
  • Provides voluntary written informed consent personally or through a legally authorized representative, if applicable.

Older Adult Group:

  • Age 55 to 70 years.
  • Has tactile sensation in the hands and fingers.
  • Provides voluntary written informed consent personally or through a legally authorized representative, if applicable.

Stroke Patient Group:

  • Age 19 years or older.
  • Diagnosis of ischemic or hemorrhagic stroke.
  • Stroke confirmed by CT or MRI.
  • Stroke accompanied by proprioceptive sensory impairment.
  • Residual tactile sensation in the fingertip.
  • Provides voluntary written informed consent personally or through a legally authorized representative,

Exclusion Criteria:

  • Young and Older Adult Groups:
  • Absence of tactile sensation in the hands or fingers.
  • Congenital deformity of the hands or fingers.
  • Presence of a major pre-existing neurogenic disease.
  • Presence of a major psychiatric disorder, such as major depressive disorder, schizophrenia, bipolar disorder, or dementia.
  • Implanted pacemaker.

Stroke Patient Group:

  • Difficulty communicating due to K-MMSE score < 23, severe language impairment, or similar condition.
  • Absence of tactile sensation in the hands or fingers.
  • Congenital deformity of the hands or fingers.
  • Severe pain during elbow joint or finger movement.
  • Progressive or unstable stroke.
  • Presence of hemispatial neglect.
  • Presence of a major pre-existing neurogenic disease.
  • Presence of a major psychiatric disorder, such as major depressive disorder, schizophrenia, bipolar disorder, or dementia.
  • Implanted pacemaker.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:其他
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:Young adults
Participants aged 19 to 54 years with tactile sensation in the hands and fingers. Participants in this group will perform electrotactile sensory discrimination tasks to assess discrimination thresholds for stimulation frequency, stimulation amplitude, and temporal gaps, as well as task accuracy and reaction time. This group may also complete both focused and cognitive load conditions.
Participants will receive non-invasive electrotactile stimulation through surface electrodes attached to the upper limb, such as the fingertip, palm, elbow, or shoulder, depending on the stimulation condition. Participants will perform sensory discrimination tasks to assess their ability to discriminate changes in stimulation frequency, stimulation amplitude, and temporal gaps in stimulation. Stimulation intensity will be individualized based on each participant's perception threshold and discomfort threshold and will remain below the discomfort threshold throughout the experiment. Task performance, including just noticeable difference, task accuracy, and reaction time, will be recorded.
实验性的:Older adults
Participants aged 55 to 70 years with tactile sensation in the hands and fingers. Participants in this group will perform electrotactile sensory discrimination tasks to assess discrimination thresholds for stimulation frequency, stimulation amplitude, and temporal gaps, as well as task accuracy and reaction time. This group may also complete both focused and cognitive load conditions.
Participants will receive non-invasive electrotactile stimulation through surface electrodes attached to the upper limb, such as the fingertip, palm, elbow, or shoulder, depending on the stimulation condition. Participants will perform sensory discrimination tasks to assess their ability to discriminate changes in stimulation frequency, stimulation amplitude, and temporal gaps in stimulation. Stimulation intensity will be individualized based on each participant's perception threshold and discomfort threshold and will remain below the discomfort threshold throughout the experiment. Task performance, including just noticeable difference, task accuracy, and reaction time, will be recorded.
实验性的:Stroke patients
Participants aged 19 years or older who have been diagnosed with ischemic or hemorrhagic stroke confirmed by CT or MRI and who have proprioceptive sensory impairment with residual tactile sensation in the fingertip. Participants in this group will undergo preliminary assessments of cognitive function, upper-limb motor function, proprioception, cutaneous sensation, and hand function before performing electrotactile sensory discrimination tasks. Stroke patients will participate in a single study visit and will not undergo the cognitive load condition to minimize fatigue and experimental burden.
Participants will receive non-invasive electrotactile stimulation through surface electrodes attached to the upper limb, such as the fingertip, palm, elbow, or shoulder, depending on the stimulation condition. Participants will perform sensory discrimination tasks to assess their ability to discriminate changes in stimulation frequency, stimulation amplitude, and temporal gaps in stimulation. Stimulation intensity will be individualized based on each participant's perception threshold and discomfort threshold and will remain below the discomfort threshold throughout the experiment. Task performance, including just noticeable difference, task accuracy, and reaction time, will be recorded.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Just Noticeable Difference for Electrotactile Sensory Discrimination
大体时间:During the experimental session, up to 2 days for young and older adult participants and 1 day for stroke patients
The just noticeable difference (JND) will be calculated as the minimum detectable difference for electrotactile stimulation frequency and amplitude, and as the threshold for detecting temporal gaps in stimulation during the electrotactile sensory discrimination tasks.
During the experimental session, up to 2 days for young and older adult participants and 1 day for stroke patients

次要结果测量

结果测量
措施说明
大体时间
Reaction Time During Electrotactile Sensory Discrimination Tasks
大体时间:During the experimental session, up to 2 days for young and older adult participants and 1 day for stroke patients
Reaction time will be measured as the time interval between stimulus presentation or response cue and the participant's behavioral response during the electrotactile sensory discrimination tasks.
During the experimental session, up to 2 days for young and older adult participants and 1 day for stroke patients

其他结果措施

结果测量
措施说明
大体时间
Effect of Cognitive Load on Electrotactile Sensory Discrimination Performance
大体时间:During the experimental session, up to 2 days
In young and older adult participants, electrotactile sensory discrimination performance under the focused condition will be compared with performance under the cognitive load condition.
During the experimental session, up to 2 days
Accuracy in Electrotactile Sensory Discrimination Tasks
大体时间:During the experimental session, up to 2 days for young and older adult participants and 1 day for participants with stroke.
Accuracy will be calculated as the percentage of trials in which participants correctly discriminate electrotactile stimulation frequency, amplitude, or temporal gaps. Accuracy will be compared among young adults, older adults, and participants with stroke.
During the experimental session, up to 2 days for young and older adult participants and 1 day for participants with stroke.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Hangue Park, PhD、Sungkyunkwan University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年6月11日

初级完成 (估计的)

2027年6月11日

研究完成 (估计的)

2028年4月30日

研究注册日期

首次提交

2026年6月10日

首先提交符合 QC 标准的

2026年6月17日

首次发布 (实际的)

2026年6月18日

研究记录更新

最后更新发布 (实际的)

2026年6月18日

上次提交的符合 QC 标准的更新

2026年6月17日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be shared with other researchers because the study includes sensitive clinical and sensory assessment data, and the current protocol does not include a data sharing plan beyond the approved research team.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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