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

17 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Descrição detalhada

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.

Tipo de estudo

Intervencional

Inscrição (Estimado)

80

Estágio

  • Não aplicável

Contactos e Locais

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Contato de estudo

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Sim

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Outro
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Experimental: 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.
Experimental: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Just Noticeable Difference for Electrotactile Sensory Discrimination
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Reaction Time During Electrotactile Sensory Discrimination Tasks
Prazo: 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

Outras medidas de resultado

Medida de resultado
Descrição da medida
Prazo
Effect of Cognitive Load on Electrotactile Sensory Discrimination Performance
Prazo: 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
Prazo: 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.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Investigadores

  • Investigador principal: Hangue Park, PhD, Sungkyunkwan University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

11 de junho de 2026

Conclusão Primária (Estimado)

11 de junho de 2027

Conclusão do estudo (Estimado)

30 de abril de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

10 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

17 de junho de 2026

Primeira postagem (Real)

18 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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