FallNCT06008431
Non-invasive Brain Stimulation to Improve Unsteady Gait in Older Adults (StimGait)
A study testing Transcranial direct current stimulation (tDCS) (active) in people with Fall and Gait, Unsteady, run by Hebrew SeniorLife at 1 site in United States.
Trial summary
Walking is a complex and continuous task that entails repetitive motions of the body. Relatively high gait variability sensitively predicts falls and cognitive decline in older adults. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fall, Gait, Unsteady, Mobility Limitation
- What is being tested?
- Transcranial direct current stimulation (tDCS) (active)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2024to 20 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged 65 and above.
- Ability to speak and read English.
- Ability to walk independently and continuously for at least 1 minute.
- Elevated gait variability as defined by a coefficient of variation (CoV) about average stride time larger and equal to 0.025 during straight-line walking at preferred speed.
Who cannot join
- More than mild cognitive impairment defined by a Montreal Cognitive Assessment (MoCA) score less than 18.
- Parkinson's disease, multiple sclerosis, stroke, active brain tumor, or other neurological disorders.
- Self-reported pain or lower extremity deformity that significantly disrupts walking.
- Contraindications to MRI or tDCS.
- An episode of acute illness or exacerbation of a diagnosis that requires hospitalization or active treatment within the past 3 months.
- Current treatment for congestive heart failure, angina, uncontrolled arrythmia, deep vein thrombosis, or other uncontrolled cardiovascular events.
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- Myocardial infarction, coronary artery bypass grafting, angioplasty, or other cardiac conditions within the past 3 months,
- Active cancer for which chemo/radiation therapy is being received.
- Psychiatric co-morbidity including major depressive disorder, schizophrenia, psychosis, or other psychiatric illness.
- Recent use of any sedating medications (sedatives, anti-psychotics, hypnotics, anti-depressants) or change in medication within the previous month.
- Chronic vertigo or other diagnosed vestibular disorders.
- Legal blindness, visual impairments that cannot be corrected with glasses, contact lenses, medicine, or surgery.
- Those without WiFi access
- Those who do not plan to live in their current homes for the duration of the study
Trial locations and contacts
1 site in 1 country.
United States1 site
Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife
Boston, Massachusetts, 02131
About this study
Official title: Modulating Brain Networks to Reduce Gait Variability in Older Adults at Risk of Falling
Walking is a complex and continuous task that entails repetitive motions of the body. Relatively high gait variability sensitively predicts falls and cognitive decline in older adults. Previous work has identified an unique brain network relationship linked to gait variability and its relevant cognitive function (i.e., sustained attention). This project aims to develop a non-invasive brain stimulation montage designed to modulate the shared brain networks dynamics and to demonstrate its effects on resting state functional connectivity, gait and cognitive performance in older adults at risk for falls.
Read the detailed description
This is a randomized controlled trial to examine the efficacy of a non-invasive brain stimulation intervention of tDCS to improve unsteady gait in older adults. The investigators will enroll 30 older adults with elevated gait variability. Participants will be randomized into one of two arms: a) 10 sessions of tDCS and b) 5 sessions of sham stimulation followed by 5 sessions of tDCS. Participants will engage in a set of pre-intervention assessments, the brain stimulation intervention - consisting of 10, once-daily, 20-min stimulation sessions over a 2-week period, and a set of post-intervention assessments. This project is expected to demonstrate that tDCS can be used to reduce gait variability in older adults.
- Conditions
- Fall, Gait, Unsteady, Mobility Limitation
- Being tested
- Transcranial direct current stimulation (tDCS) (active), Transcranial direct current stimulation (tDCS) (Sham)
- Keywords
- transcranial direct current stimulation (tDCS), transcranial electrical stimulation (tES), Non-invasive brain stimulation (NIBS), Falls, Gait Variability, Sustained Attention, Dorsal Attention Network, Default Network
- Medical subject headings
- Gait Disorders, Neurologic, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial direct current stimulation (tDCS) (active)Device
The tDCS montage is developed to modulate the functional connectivity between the dorsal attention network and the default network.
Transcranial direct current stimulation (tDCS) (Sham)Device
The tDCS "Acti-" Sham montage is developed to recreate the cutaneous sensations associated with tDCS, yet essentially a null electrical field over the networks of interest.
| Study group | Role | What they receive |
|---|---|---|
| tDCS intervention | Experimental | Ten, once-daily, 20-min sessions of tDCS will be provided over two consecutive weeks. Receives: Device: Transcranial direct current stimulation (tDCS) (active) |
| Sham and then tDCS | Sham comparator | Five, once-daily, 20-min sessions of sham in week one followed by five, once-daily, 20-min sessions of tDCS in week two. Receives: Device: Transcranial direct current stimulation (tDCS) (active); Device: Transcranial direct current stimulation (tDCS) (Sham) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gait variability
This measure is captured by both Mobility Lab (APDM Inc) and the smart phone App. Gait variability is defined as the coefficient of variation to validated stride times.
Measured: Baseline, Immediate post-intervention, 1 month follow up
Secondary outcomes (3)
Gait speed
This measure is captured by Mobility Lab (APDM InC). Gait speed id defined by the time one takes to walk a specified distance.
Measured: Baseline, Immediate post-intervention, 1 month follow up
Dual-task gait performance
Participants will be asked to walk under two conditions: 1) walk at a comfortable, self-selected speed and 2) walk while counting backward by 1' or 3's from a random 3-digit number. Dual-task gait characteristics will be captured while the participants concurrently walk and count. We will further calculate the cost one takes to complete the dual-task walking from walking at a comfortable, self-selected speed.
Measured: Baseline, Immediate post-intervention, 1 month follow up
Accuracy (d prime) on the gradual onset continuous performance task (gradCPT)
The gradCPT is a computer-based cognitive task designed to measure sustained attention. Accuracy (d prime) on the gradCPT can be derived from the gradCPT analysis tool box.
Measured: Baseline, Immediate post-intervention, 1 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start3 Jun 2024
- Primary completion20 Nov 2025
- Study completion20 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- On-Yee Lo, Ph.D., Principal investigator, Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06008431
- Sponsor's protocol ID
- Pro00057363
- Other IDs
- K01AG075252
- Status last verified
- Jun 2025
- First submitted
- 18 Aug 2023
- Last updated
- 21 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The prospective plan is to have data available in a data repository.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulating Brain Networks to Reduce Gait Variability in Older Adults at Risk of Falling
- ClinicalTrials.gov ID
- NCT06008431
- Acronym / sponsor ID
- Pro00057363
- Conditions
- Fall, Gait, Unsteady, Mobility Limitation
- Keywords
- transcranial direct current stimulation (tDCS), transcranial electrical stimulation (tES), Non-invasive brain stimulation (NIBS), Falls, Gait Variability, Sustained Attention, Dorsal Attention Network, Default Network
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 20 Nov 2025 (actual)
- First posted
- 23 Aug 2023 (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.
Walking is a complex and continuous task that entails repetitive motions of the body. Relatively high gait variability sensitively predicts falls and cognitive decline in older adults. Previous work has identified an unique brain network relationship linked to gait variability and its relevant cognitive function (i.e., sustained attention). This project aims to develop a non-invasive brain stimulation montage designed to modulate the shared brain networks dynamics and to demonstrate its effects on resting state functional connectivity, gait and cognitive performance in older adults at risk for falls.
Detailed description
This is a randomized controlled trial to examine the efficacy of a non-invasive brain stimulation intervention of tDCS to improve unsteady gait in older adults. The investigators will enroll 30 older adults with elevated gait variability. Participants will be randomized into one of two arms: a) 10 sessions of tDCS and b) 5 sessions of sham stimulation followed by 5 sessions of tDCS. Participants will engage in a set of pre-intervention assessments, the brain stimulation intervention - consisting of 10, once-daily, 20-min stimulation sessions over a 2-week period, and a set of post-intervention assessments. This project is expected to demonstrate that tDCS can be used to reduce gait variability in older adults.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| tDCS intervention | Experimental | Device: Transcranial direct current stimulation (tDCS) (active)Ten, once-daily, 20-min sessions of tDCS will be provided over two consecutive weeks. |
| Sham and then tDCS | Sham comparator | Device: Transcranial direct current stimulation (tDCS) (active), Device: Transcranial direct current stimulation (tDCS) (Sham)Five, once-daily, 20-min sessions of sham in week one followed by five, once-daily, 20-min sessions of tDCS in week two. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Aged 65 and above.
- Ability to speak and read English.
- Ability to walk independently and continuously for at least 1 minute.
- Elevated gait variability as defined by a coefficient of variation (CoV) about average stride time larger and equal to 0.025 during straight-line walking at preferred speed.
Key exclusion criteria (14 listed)
- More than mild cognitive impairment defined by a Montreal Cognitive Assessment (MoCA) score less than 18.
- Parkinson's disease, multiple sclerosis, stroke, active brain tumor, or other neurological disorders.
- Self-reported pain or lower extremity deformity that significantly disrupts walking.
- Contraindications to MRI or tDCS.
- An episode of acute illness or exacerbation of a diagnosis that requires hospitalization or active treatment within the past 3 months.
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 stimulation (tDCS) (active)The tDCS montage is developed to modulate the functional connectivity between the dorsal attention network and the default network. | Device | Sham and then tDCS, tDCS intervention |
| Transcranial direct current stimulation (tDCS) (Sham)The tDCS "Acti-" Sham montage is developed to recreate the cutaneous sensations associated with tDCS, yet essentially a null electrical field over the networks of interest. | Device | Sham and then tDCS |
Primary outcome
Gait variability
Time frame: Baseline, Immediate post-intervention, 1 month follow up
This measure is captured by both Mobility Lab (APDM Inc) and the smart phone App. Gait variability is defined as the coefficient of variation to validated stride times.
3 secondary outcomes
Gait speed
Time frame: Baseline, Immediate post-intervention, 1 month follow up
Dual-task gait performance
Time frame: Baseline, Immediate post-intervention, 1 month follow up
Accuracy (d prime) on the gradual onset continuous performance task (gradCPT)
Time frame: Baseline, Immediate post-intervention, 1 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2026.
- Individual participant dataSharing planned: Yes. The prospective plan is to have data available in a data repository.
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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. This study is not recruiting at the moment.
On-Yee Lo, Ph.D. principal investigator
Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife
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 (tDCS) (active) in people with Fall and Gait, Unsteady, 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 4 inclusion and 14 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: finished, as of the sponsor's last update on 21 Jan 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gait variability (time frame: Baseline, Immediate post-intervention, 1 month follow up). 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 21 Jan 2026.