Recruiting

tDCS

Sponsor:

Hebrew SeniorLife

Code:

NCT06771531

Conditions

Somatosensory Function

Balance Control

Mobility

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

Interventions

transcranial direct current stimulation

active sham stimulation

Study Details

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.

Conditions

Somatosensory Function

Balance Control

Mobility

Study ID

NCT06771531

Start date

Feb 26, 2026

Status verified date

Mar, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Jul 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 65+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: tDCS group

Participants in this arm will receive the real tDCS intervention.

sham comparator: sham group

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

Interventions

transcranial 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.

active 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.

Primary outcome measure

  • postural sway area when standing with eyes closed on the foam [ Time Frame: Before and immediately after intervention ]
  • Timed Up-and-Go (TUG) time [ Time Frame: Before and immediately after intervention ]
  • On-target Blood oxygen level dependent (BOLD) signal intensity in response to foot sole stimulation [ Time Frame: Before and immediately after intervention ]
  • Standing vibratory thresholds of each foot sole [ Time Frame: Before and immediately after intervention ]

Central Contacts and Locations

Central contacts

Locations

Hebrew SeniorLife

Recruiting

Roslindale, Massachusetts, United States, 02131

Contacts

More Information

Sponsor

Hebrew SeniorLife

Last update posted

Apr 22, 2026

Last verified

Mar, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hebrew SeniorLife on 2026-04-22.