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

Last updated: June 13, 2025
Sponsor: Hebrew SeniorLife
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Transcranial direct current stimulation (tDCS) (active)

Transcranial direct current stimulation (tDCS) (Sham)

Clinical Study ID

NCT06008431
Pro00057363
K01AG075252
  • Ages > 65
  • All Genders
  • Accepts Healthy Volunteers

Study 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. 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.

Eligibility Criteria

Inclusion

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) aboutaverage stride time larger and equal to 0.025 during straight-line walking atpreferred speed.

Exclusion

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 otherneurological 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 requireshospitalization or active treatment within the past 3 months.

  • Current treatment for congestive heart failure, angina, uncontrolled arrythmia, deepvein thrombosis, or other uncontrolled cardiovascular events.

  • Myocardial infarction, coronary artery bypass grafting, angioplasty, or othercardiac 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, contactlenses, 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 Design

Total Participants: 30
Treatment Group(s): 2
Primary Treatment: Transcranial direct current stimulation (tDCS) (active)
Phase:
Study Start date:
June 03, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife

    Boston, Massachusetts 02131
    United States

    Active - Recruiting

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