Actively Recruiting

Phase Not Applicable
Age: 65Years +
All Genders
ID06771531

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

Led by Hebrew SeniorLife · Updated on 2026-04-22

20

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

H

Hebrew SeniorLife

Lead Sponsor

N

National Institute on Aging (NIA)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating the use of noninvasive brain stimulation to improve foot sole sensation, balance, and mobility in older adults who have mild-to-moderate sensory impairments in their feet. This study focuses on understanding how stimulating brain networks that process sensory feedback can help with these issues, which are common in older adults and affect their stability and movement. The project is led by Hebrew SeniorLife and does not involve drug treatments but uses device-based brain stimulation methods. Participants will be randomly assigned to one of two groups: one group will receive real transcranial direct current stimulation (tDCS), which applies weak electrical currents to the scalp to increase brain activity related to sensory processing; the other group will receive a sham (placebo-like) stimulation that mimics the sensations of tDCS without delivering effective currents. The stimulation sessions last 20 minutes, and the current used will not exceed safety limits. The study uses triple masking to keep participants and researchers unaware of group assignments. During the study, participants will undergo various assessments before and immediately after the intervention, including tests of balance (such as postural sway while standing with eyes closed on foam), mobility (Timed Up-and-Go time), brain activity responses to foot sole stimulation using imaging, and foot sole sensitivity. Secondary measures include gait speed and postural sway speed. The total participation period includes these evaluations around the stimulation sessions. Safety and tolerability are monitored throughout the study.

CONDITIONS

Brief Title

Brain Stimulation for Foot-sole Sensation in Older Adults With Foot-sole Somatosensory Deficits

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 65 years or older
  • Self-reported feeling of unsteadiness or difficulty when standing and walking
  • Mild-to-moderate foot-sole sensory impairment, able to feel 75g monofilament but not 10g monofilament
Not Eligible

You will not qualify if you...

  • Unable to stand or walk continuously for one minute without personal assistance (canes or walkers allowed)
  • History or presence of foot ulceration, amputation, or foot deformities
  • Uncontrolled pain or pain affecting mobility
  • Uncontrolled diabetes mellitus
  • Hospitalization in past three months due to acute illness or musculoskeletal injury affecting balance
  • Severe persistent lower extremity pain when standing or walking
  • Diagnosis of dementia, Parkinson's disease, or stroke affecting balance
  • Unstable medical condition
  • Legal blindness or deafness
  • Uncontrolled hypertension (systolic BP >180, diastolic BP >100 mm Hg, or use of 3 or more anti-hypertensive medications)
  • Severe kidney or liver disease, nephropathy, renal or congestive heart failure
  • Active cancer treatment
  • Balance disorders from past chemotherapy or Guillain-Barré syndrome
  • Use of neuro-active or recreational drugs or alcohol abuse affecting brain excitability
  • Contraindications to MRI or tDCS (e.g., seizures, metallic implants, claustrophobia, brain surgery)
  • Persistent vertigo
  • History of Charcot-Marie-Tooth nerve disease

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - Single 20-minute session per intervention with crossover design

Participants receive either real or sham transcranial direct current stimulation (tDCS) in sessions to modulate cortical excitability related to foot-sole sensation.

2 visits (one for each intervention session)

Trial Site Locations

Total: 1 location

1

Hebrew SeniorLife

Roslindale, Massachusetts, United States, 02131

Actively Recruiting

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Research Team

J

Junhong Zhou, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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