Brain stimulation to improve foot-sole sensation and balance in older adults

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

This project will test whether mild electrical stimulation of the brain can improve foot-sole feeling, standing balance, and walking in people 65 and older who have mild-to-moderate loss of foot sensation.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 65 Years and up
• Sex: All
• Sponsor: Hebrew SeniorLife (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Roslindale, Massachusetts)
• Trial ID: NCT06771531 on ClinicalTrials.gov

What this trial studies

This interventional protocol uses transcranial direct current stimulation (tDCS) applied to brain regions that process foot-sole sensory feedback and compares active stimulation with a matched sham condition. Older adults with self-reported unsteadiness and measurable mild-to-moderate foot-sole sensory impairment (can feel 75g but not 10g monofilament) will be enrolled. Outcome measures include changes in foot-sole perception, standing balance, and mobility performance measured before and after interventions. The design focuses on short-term changes in sensory and mobility function to determine whether augmenting cortical excitability produces measurable functional gains.

Who should consider this trial

Good fit: Ideal candidates are adults aged 65 or older who feel unsteady when standing or walking and have mild-to-moderate foot-sole sensory loss as defined by monofilament testing, and who can stand or walk for at least one minute without personal assistance.

Not a fit: People with severe neuropathy or major neurologic diseases that affect balance (for example, advanced dementia, Parkinson's disease, recent stroke), uncontrolled medical problems, foot ulceration or amputation, or those unable to stand/walk safely are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this approach could improve foot sensation and balance, which might reduce fall risk and help older adults maintain mobility.

How similar studies have performed: Prior small studies of tDCS for sensory, balance, or gait improvements have shown some promising but variable and limited effects, so evidence to date is suggestive but not definitive.

Eligibility criteria

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.

Where this trial is running

Roslindale, Massachusetts

• Hebrew SeniorLife — Roslindale, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Junhong Zhou, PhD

Conditions Somatosensory Function; Balance Control; Mobility; brain stimulation; balance and mobility; foot-sole somatosensory function