Non-invasive Brain Stimulation to Improve Unsteady Gait in Older Adults (StimGait)

NCT ID: NCT06008431

Last Updated: 2026-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-03

Study Completion Date

2025-11-20

Brief Summary

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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

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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

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Fall Gait, Unsteady Mobility Limitation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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tDCS intervention

Ten, once-daily, 20-min sessions of tDCS will be provided over two consecutive weeks.

Group Type EXPERIMENTAL

Transcranial direct current stimulation (tDCS) (active)

Intervention Type DEVICE

The tDCS montage is developed to modulate the functional connectivity between the dorsal attention network and the default network.

Sham and then tDCS

Five, once-daily, 20-min sessions of sham in week one followed by five, once-daily, 20-min sessions of tDCS in week two.

Group Type SHAM_COMPARATOR

Transcranial direct current stimulation (tDCS) (active)

Intervention Type 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)

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
* 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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Hebrew SeniorLife

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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On-Yee Lo, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife

Locations

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Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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K01AG075252

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00057363

Identifier Type: -

Identifier Source: org_study_id

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