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Completed

NCT Number: NCT06008431

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

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife

Boston, Massachusetts, 02131, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Hebrew SeniorLife

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Modulating Brain Networks to Reduce Gait Variability in Older Adults at Risk of Falling

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 23, 2023
Registry last updated
Jan 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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