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

17 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

80

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Altro
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Sperimentale: 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.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Just Noticeable Difference for Electrotactile Sensory Discrimination
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Reaction Time During Electrotactile Sensory Discrimination Tasks
Lasso di tempo: 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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Effect of Cognitive Load on Electrotactile Sensory Discrimination Performance
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Hangue Park, PhD, Sungkyunkwan University

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

11 giugno 2026

Completamento primario (Stimato)

11 giugno 2027

Completamento dello studio (Stimato)

30 aprile 2028

Date di iscrizione allo studio

Primo inviato

10 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 giugno 2026

Primo Inserito (Effettivo)

18 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano 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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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