- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07656675
Electrotactile Frequency, Amplitude, and Temporal Gap Discrimination in Young Adults, Older Adults, and Stroke Survivors (ESD-NR)
Assessment of Electrotactile Sensory Discrimination Across Young Adults, Older Adults, and Stroke Survivors for Neurorehabilitation Feedback Design
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: June Seung Lee, MS
- Telefonní číslo: +82-10-2087-0016
- E-mail: iijjuness@g.skku.edu
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Jiný
- Přidělení: Nerandomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
|
Experimentální: 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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Just Noticeable Difference for Electrotactile Sensory Discrimination
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Reaction Time During Electrotactile Sensory Discrimination Tasks
Časové okno: 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
|
Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Effect of Cognitive Load on Electrotactile Sensory Discrimination Performance
Časové okno: 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
Časové okno: 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.
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Hangue Park, PhD, Sungkyunkwan University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2026-05-012-001
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