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Clinical Trials/NCT06771531
NCT06771531
Recruiting
Not Applicable

Cortical Mechanisms and Modulation of Somatosensation in Older Adults With Foot Sole Somatosensory Impairments

Hebrew SeniorLife1 site in 1 country20 target enrollmentFebruary 26, 2026

Overview

Phase
Not Applicable
Intervention
transcranial direct current stimulation
Conditions
Somatosensory Function
Sponsor
Hebrew SeniorLife
Enrollment
20
Locations
1
Primary Endpoint
postural sway area when standing with eyes closed on the foam
Status
Recruiting
Last Updated
10 days ago

Overview

Brief Summary

In older adults, diminished sensation of the legs and feet is highly prevalent and causes poor balance and reduced mobility. This type of sensation is not only dependent upon the receptors and nerves in the legs and feet, but also upon a complex central nervous system pathway that includes the cerebral cortex of the brain. This project will use a form of noninvasive brain stimulation called transcranial direct current stimulation (tDCS) to test whether increasing the excitability of the brain networks that process sensory feedback can augment foot sole sensation, balance, and mobility in older adults suffering from mild-to-moderate foot sole sensory impairments.

Registry
clinicaltrials.gov
Start Date
February 26, 2026
End Date
December 31, 2026
Last Updated
10 days ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Hebrew SeniorLife
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Aged ≥65 years.
  • Self-reported feeling of unsteadiness or difficulty when standing and walking.
  • Mild-to-moderate foot-sole somatosensory impairment: the ability to perceive 75g monofilament but inability to perceive 10g monofilament.

Exclusion Criteria

  • self-reported inability to stand or walk continuously for one minute without personal assistance (canes or walkers allowed);
  • history or presence of foot ulceration, amputation, or deformities;
  • self-reported uncontrolled pain or pain that is associated with mobility disability;
  • uncontrolled diabetes mellitus;
  • hospitalization within the past three months due to acute illness, or as the result of a musculoskeletal injury significantly affecting balance;
  • persistent severe pain of lower extremity when standing or walking;
  • diagnosis of dementia, Parkinson's disease, or stroke that affects balance;
  • unstable medical condition;
  • legal blindness or deafness;
  • uncontrolled hypertension (i.e., systolic BP \>180, diastolic BP \>100 mm Hg, or prescription of ≥3 anti-hypertensive medications);

Arms & Interventions

tDCS group

Participants in this arm will receive the real tDCS intervention.

Intervention: transcranial direct current stimulation

sham group

Participants in this arm will receive the sham stimulation as control.

Intervention: active sham stimulation

Outcomes

Primary Outcomes

postural sway area when standing with eyes closed on the foam

Time Frame: Before and immediately after intervention

This metric assesses the degree to which the soft support and cut-off of the vision diminishes the control of standing posture.

Standing vibratory thresholds of each foot sole

Time Frame: Before and immediately after intervention

This metric assesses the degree to which the foot soles can sense the vibro-tactile stimuli when standing.

postural sway area when standing with eyes closed on the foam

Time Frame: Before and immediately after intervention

This metric assesses the degree to which the soft support and cut-off of the vision diminishes the control of standing posture.

Timed Up-and-Go (TUG) time

Time Frame: Before and immediately after intervention

This metric assesses mobility.

On-target Blood oxygen level dependent (BOLD) signal intensity in response to foot sole stimulation

Time Frame: Before and immediately after intervention

This metric assesses the degree to which brain cortical regions activated by the walking-related foot-sole stimulation.

Standing vibratory thresholds of each foot sole

Time Frame: Before and immediately after intervention

This metric assesses the degree to which the foot soles can sense the vibro-tactile stimuli when standing.

Secondary Outcomes

  • Gait speed of 10m walking test(Before and immediately after intervention)
  • Postural sway speed when standing with eyes closed on the foam(Before and immediately after intervention)

Study Sites (1)

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