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NCT Number: NCT06771531

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hebrew SeniorLife

Roslindale, Massachusetts, 02131, United States

Location status: Recruiting

Location contact

Kathy Tasker

CONTACT

[email protected]

617-971-5351

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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);
  • functionally limiting nephropathy, severe diseases or transplant of the kidney or liver, renal or congestive heart failure;
  • active cancer treatment;
  • balance disorders due to past use of chemotherapy or history of Guillain-Barré syndrome;
  • use of neuro-active or recreational drugs (e.g., sedatives, anti-psychotics), or alcohol abuse, which may affect the brain excitability;
  • contraindications to MRI or tDCS (e.g., personal or family history of seizures or epilepsy, metallic or electric bio-implants, claustrophobia, brain surgery);
  • persistent vertigo;
  • history of Charcot-Marie-Tooth nerve disease.

Treatment and study plan

Transcranial Direct Current Stimulation

Device

tDCS can safely and selectively modulate cortical excitability (specifically neuronal firing likelihood) by transferring weak electrical currents between scalp electrodes. The direct current delivered by any one electrode will not exceed 2.0 mA and the total amount of current from all electrodes will not exceed 4 mA in this study.

active sham stimulation

Device

sham stimulation will implement the same protocol of the tDCS intervention; however, only very low-level currents (no more than 0.5 mA) are transferred between the same electrodes used for the tDCS throughout the 20-minute session. This strategy effectively mimics the cutaneous sensations and skin redness induced by creating only micro cortical electric fields.

Primary outcomes

  1. 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.

  2. Timed Up-and-Go (TUG) time

    Time frame: Before and immediately after intervention

    This metric assesses mobility.

  3. 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.

  4. 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

  1. Postural sway speed 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.

  2. Gait speed of 10m walking test

    Time frame: Before and immediately after intervention

    This metric assesses mobility.

Other outcomes

  1. BOLD signal intensity within other relevant cortical regions 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Junhong Zhou, PhD

CONTACT

[email protected]

617-971-5346

Sponsors and collaborators

Lead sponsor

Hebrew SeniorLife

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: BSFS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 13, 2025
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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