Somatosensory FunctionBSFSNCT06771531
Brain Stimulation for Foot-sole Sensation in Older Adults With Foot-sole Somatosensory Deficits
A study testing transcranial direct current stimulation in people with Somatosensory Function and Balance Control, run by Hebrew SeniorLife at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Somatosensory Function, Balance Control, Mobility
- What is being tested?
- transcranial direct current stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hebrew SeniorLife
Roslindale, Massachusetts, 02131
Kathy Tasker, 617-971-5351, KathyTasker@hsl.harvard.edu
About this study
Official title: Cortical Mechanisms and Modulation of Somatosensation in Older Adults With Foot Sole Somatosensory Impairments
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
- Being tested
- transcranial direct current stimulation, active sham stimulation
- Keywords
- brain stimulation, balance and mobility, foot-sole somatosensory function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transcranial direct current stimulationDevice
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 stimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| tDCS group | Experimental | Participants in this arm will receive the real tDCS intervention. Receives: Device: transcranial direct current stimulation |
| sham group | Sham comparator | Participants in this arm will receive the sham stimulation as control. Receives: Device: active sham stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
postural sway area when standing with eyes closed on the foam
This metric assesses the degree to which the soft support and cut-off of the vision diminishes the control of standing posture.
Measured: Before and immediately after intervention
Timed Up-and-Go (TUG) time
This metric assesses mobility.
Measured: Before and immediately after intervention
On-target Blood oxygen level dependent (BOLD) signal intensity in response to foot sole stimulation
This metric assesses the degree to which brain cortical regions activated by the walking-related foot-sole stimulation.
Measured: Before and immediately after intervention
Standing vibratory thresholds of each foot sole
This metric assesses the degree to which the foot soles can sense the vibro-tactile stimuli when standing.
Measured: Before and immediately after intervention
Secondary outcomes (2)
Postural sway speed when standing with eyes closed on the foam
This metric assesses the degree to which the soft support and cut-off of the vision diminishes the control of standing posture.
Measured: Before and immediately after intervention
Gait speed of 10m walking test
This metric assesses mobility.
Measured: Before and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2025
- Study start26 Feb 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Somatosensory FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06771531
- Sponsor's protocol ID
- Pro00044674
- Other IDs
- K01AG075180
- Acronym
- BSFS
- Status last verified
- Sep 2026
- First submitted
- 8 Jan 2025
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cortical Mechanisms and Modulation of Somatosensation in Older Adults With Foot Sole Somatosensory Impairments
- ClinicalTrials.gov ID
- NCT06771531
- Acronym / sponsor ID
- BSFS / Pro00044674
- Conditions
- Somatosensory Function, Balance Control, Mobility
- Keywords
- brain stimulation, balance and mobility, foot-sole somatosensory function
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 13 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS group | Experimental | Device: transcranial direct current stimulationParticipants in this arm will receive the real tDCS intervention. |
| sham group | Sham comparator | Device: active sham stimulationParticipants in this arm will receive the sham stimulation as control. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transcranial direct current stimulationtDCS 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. | Device | tDCS group |
| active sham stimulationsham 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. | Device | sham group |
Primary outcome
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.
Timed Up-and-Go (TUG) time
Time frame: Before and immediately after intervention
This metric assesses mobility.
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.
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.
2 secondary outcomes
Postural sway speed when standing with eyes closed on the foam
Time frame: Before and immediately after intervention
Gait speed of 10m walking test
Time frame: Before and immediately after intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing transcranial direct current stimulation in people with Somatosensory Function and Balance Control, run by Hebrew SeniorLife at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Junhong Zhou, PhD (617-971-5346, junhongzhou@hsl.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postural sway area when standing with eyes closed on the foam (time frame: Before and immediately after intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.