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StrokeESD-NRNCT07656675

Electrotactile Frequency, Amplitude, and Temporal Gap Discrimination in Young Adults, Older Adults, and Stroke Survivors

A study testing Electrotactile Sensory Discrimination Tasks in people with Stroke, run by Sungkyunkwan University.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 19 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Stroke
What is being tested?
Electrotactile Sensory Discrimination Tasks
Could I receive a placebo?
No, everyone receives an active treatment
How many people
80 participants
Where
No sites listed yet
Study dates
11 Nov 2026to 30 Apr 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 19 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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,

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

June Seung Lee, MS contact

+82-10-2087-0016

iijjuness@g.skku.edu

About this study

Official title: 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 and amplitude, as well as temporal resolution using a gap-in-noise detection task. Task accuracy and reaction time will also be evaluated. In selected experimental conditions, electroencephalography (EEG) will be recorded non-invasively from the scalp during electrotactile stimulation to investigate neural responses associated with electrotactile sensory processing.

The results are expected to provide foundational data for sensory assessment, electrotactile feedback design, and sensory-based rehabilitation technologies for older adults and patients with stroke.

Read the detailed description

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, frequency and amplitude JNDs will be used to evaluate discrimination ability for changes in electrotactile stimulation frequency and amplitude. Temporal sensory resolution will be evaluated using a gap-in-noise (GIN) detection task, in which participants detect brief interruptions embedded within continuous electrotactile stimulation. 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 patients with stroke. Young and older adult participants will visit the laboratory on two consecutive days and perform electrotactile sensory discrimination tasks. Patients with stroke will participate in a single study visit. Before the main experiment, patients with stroke 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 continuous electrotactile stimulation containing brief temporal gaps, and their ability to detect short interruptions in stimulation will be evaluated.

In selected experimental conditions, electroencephalography (EEG) will be recorded non-invasively from the scalp during electrotactile stimulation. EEG recording will be used to characterize neural responses associated with the processing of electrotactile sensory information. EEG measures may include time-locked neural responses and changes in neural activity associated with different electrotactile stimulation parameters and sensory discrimination performance. EEG recording itself does not deliver electrical stimulation to the participant and is used only to measure electrical activity generated by the brain.

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. Patients with stroke 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, patients with stroke 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 participants with stroke, 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.

Conditions
Stroke
Being tested
Electrotactile Sensory Discrimination Tasks
Keywords
Electrotactile stimulation, Sensory discrimination, Just noticeable difference, Tactile perception, Proprioception, Stroke rehabilitation, Aging, Cognitive load
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Electrotactile Sensory Discrimination TasksBehavioural

    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.

Study groups in NCT07656675
Study groupRoleWhat they receive
Young adultsExperimentalParticipants 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.
Receives: Behavioral: Electrotactile Sensory Discrimination Tasks
Older adultsExperimentalParticipants 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.
Receives: Behavioral: Electrotactile Sensory Discrimination Tasks
Stroke patientsExperimentalParticipants 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.
Receives: Behavioral: Electrotactile Sensory Discrimination Tasks

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Just Noticeable Difference for Electrotactile Sensory Discrimination

    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.

    Measured: During the experimental session, up to 2 days for young and older adult participants and 1 day for stroke patients

Secondary outcomes (1)
  1. Reaction Time During Electrotactile Sensory Discrimination Tasks

    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.

    Measured: During the experimental session, up to 2 days for young and older adult participants and 1 day for stroke patients

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2026
  2. Study start11 Nov 2026 (estimated)
  3. Primary completion11 Dec 2027 (estimated)
  4. Study completion30 Apr 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Participants will be assigned to one of three groups based on age and clinical status: young adults, older adults, and patients with stroke. All participants will perform electrotactile sensory discrimination tasks, and outcomes including just noticeable difference, task accuracy, and reaction time will be compared across groups.
Masking
None (open label)
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07656675
Sponsor's protocol ID
2026-05-012-001
Acronym
ESD-NR
Status last verified
Sep 2026
First submitted
10 Jun 2026
Last updated
23 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing Electrotactile Sensory Discrimination Tasks in people with Stroke, run by Sungkyunkwan University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact June Seung Lee, MS (+82-10-2087-0016, iijjuness@g.skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Just Noticeable Difference for Electrotactile Sensory Discrimination (time frame: During the experimental session, up to 2 days for young and older adult participants and 1 day for stroke patients). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.

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