NCT07656675

Brief 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 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable stroke

Timeline
21mo left

Started Jun 2026

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Jun 2026Apr 2028

First Submitted

Initial submission to the registry

June 10, 2026

Completed
1 day until next milestone

Study Start

First participant enrolled

June 11, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 18, 2026

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 11, 2027

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2028

Last Updated

June 18, 2026

Status Verified

June 1, 2026

Enrollment Period

1 year

First QC Date

June 10, 2026

Last Update Submit

June 17, 2026

Conditions

Keywords

Electrotactile stimulationSensory discriminationJust noticeable differenceTactile perceptionProprioceptionStroke rehabilitationAgingCognitive load

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

  • Reaction Time During Electrotactile Sensory Discrimination Tasks

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

Other Outcomes (2)

  • Effect of Cognitive Load on Electrotactile Sensory Discrimination Performance

    During the experimental session, up to 2 days

  • Accuracy in Electrotactile Sensory Discrimination Tasks

    During the experimental session, up to 2 days for young and older adult participants and 1 day for participants with stroke.

Study Arms (3)

Young adults

EXPERIMENTAL

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.

Behavioral: Electrotactile Sensory Discrimination Tasks

Older adults

EXPERIMENTAL

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.

Behavioral: Electrotactile Sensory Discrimination Tasks

Stroke patients

EXPERIMENTAL

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.

Behavioral: Electrotactile Sensory Discrimination Tasks

Interventions

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.

Older adultsStroke patientsYoung adults

Eligibility Criteria

Age19 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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,

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Hangue Park, PhD

    Sungkyunkwan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

June Seung Lee, MS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
No masking will be used because participants are grouped according to age and clinical status, and the study procedures involve behavioral electrotactile sensory discrimination tasks.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 10, 2026

First Posted

June 18, 2026

Study Start

June 11, 2026

Primary Completion (Estimated)

June 11, 2027

Study Completion (Estimated)

April 30, 2028

Last Updated

June 18, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

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.