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

January 16, 2026 updated by: Hebrew SeniorLife

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

27

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: tDCS intervention
Ten, once-daily, 20-min sessions of tDCS will be provided over two consecutive weeks.
Device: 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.
Sham Comparator: 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.
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.
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, Immediate post-intervention, 1 month follow up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gait speed
Time Frame: Baseline, Immediate post-intervention, 1 month follow up
This measure is captured by Mobility Lab (APDM InC). Gait speed id defined by the time one takes to walk a specified distance.
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
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.
Baseline, Immediate post-intervention, 1 month follow up
Dual-task gait performance
Time Frame: Baseline, Immediate post-intervention, 1 month follow up
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.
Baseline, Immediate post-intervention, 1 month follow up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hebrew SeniorLife

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: On-Yee Lo, Ph.D., Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2024

Primary Completion (Actual)

November 20, 2025

Study Completion (Actual)

November 20, 2025

Study Registration Dates

First Submitted

August 18, 2023

First Submitted That Met QC Criteria

August 18, 2023

First Posted (Actual)

August 23, 2023

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00057363
  • K01AG075252 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The prospective plan is to have data available in a data repository.

IPD Sharing Time Frame

The data will be available when the data are unblinded.

IPD Sharing Access Criteria

Depending on the repositories in which the data is held. Use of the data will be restricted by permission and appropriate human subjects review of the prospective project.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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