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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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06771531
Acronym
BSFS
Enrollment
20
Registered
2025-01-13
Start date
2026-02-26
Completion date
2026-12-31
Last updated
2026-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Balance Control, Mobility, Somatosensory Function

Keywords

brain stimulation, balance and mobility, foot-sole somatosensory function

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.

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.

Sponsors

Hebrew SeniorLife
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Aged ≥65 years. 2. Self-reported feeling of unsteadiness or difficulty when standing and walking. 3. Mild-to-moderate foot-sole somatosensory impairment: the ability to perceive 75g monofilament but inability to perceive 10g monofilament.

Exclusion criteria

1. self-reported inability to stand or walk continuously for one minute without personal assistance (canes or walkers allowed); 2. history or presence of foot ulceration, amputation, or deformities; 3. self-reported uncontrolled pain or pain that is associated with mobility disability; 4. uncontrolled diabetes mellitus; 5. hospitalization within the past three months due to acute illness, or as the result of a musculoskeletal injury significantly affecting balance; 6. persistent severe pain of lower extremity when standing or walking; 7. diagnosis of dementia, Parkinson's disease, or stroke that affects balance; 8. unstable medical condition; 9. legal blindness or deafness; 10. uncontrolled hypertension (i.e., systolic BP \>180, diastolic BP \>100 mm Hg, or prescription of ≥3 anti-hypertensive medications); 11. functionally limiting nephropathy, severe diseases or transplant of the kidney or liver, renal or congestive heart failure; 12. active cancer treatment; 13. balance disorders due to past use of chemotherapy or history of Guillain-Barré syndrome; 14. use of neuro-active or recreational drugs (e.g., sedatives, anti-psychotics), or alcohol abuse, which may affect the brain excitability; 15. contraindications to MRI or tDCS (e.g., personal or family history of seizures or epilepsy, metallic or electric bio-implants, claustrophobia, brain surgery); 16. persistent vertigo; 17. history of Charcot-Marie-Tooth nerve disease.

Design outcomes

Primary

MeasureTime frameDescription
postural sway area when standing with eyes closed on the foamBefore and immediately after interventionThis 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) timeBefore and immediately after interventionThis metric assesses mobility.
On-target Blood oxygen level dependent (BOLD) signal intensity in response to foot sole stimulationBefore and immediately after interventionThis metric assesses the degree to which brain cortical regions activated by the walking-related foot-sole stimulation.
Standing vibratory thresholds of each foot soleBefore and immediately after interventionThis metric assesses the degree to which the foot soles can sense the vibro-tactile stimuli when standing.

Secondary

MeasureTime frameDescription
Postural sway speed when standing with eyes closed on the foamBefore and immediately after interventionThis metric assesses the degree to which the soft support and cut-off of the vision diminishes the control of standing posture.
Gait speed of 10m walking testBefore and immediately after interventionThis metric assesses mobility.

Countries

United States

Contacts

CONTACTJunhong Zhou, PhD
junhongzhou@hsl.harvard.edu617-971-5346

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 23, 2026