RecruitingNot ApplicableNCT06771531

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

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


Sponsor

Hebrew SeniorLife

Enrollment

20 participants

Start Date

Mar 9, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 65 Years

Inclusion Criteria3

  • 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 Criteria17

  • 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.

Interventions

DEVICEtranscranial direct current stimulation

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.

DEVICEactive sham stimulation

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.


Locations(1)

Hebrew SeniorLife

Roslindale, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06771531


Related Trials