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

NCT06008431 | Completed DMC FDA Device

• 2 other identifiers: Pro00057363K01AG075252
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief 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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline, Immediate post-intervention, 1 month follow up

Secondary Outcomes (3)

• Gait speed

  Baseline, Immediate post-intervention, 1 month follow up

• Dual-task gait performance

  Baseline, Immediate post-intervention, 1 month follow up

• Accuracy (d prime) on the gradual onset continuous performance task (gradCPT)

  Baseline, Immediate post-intervention, 1 month follow up

Study Arms (2)

tDCS intervention

EXPERIMENTAL

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

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.

Device: Transcranial direct current stimulation (tDCS) (active); Device: Transcranial direct current stimulation (tDCS) (Sham)

Interventions

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.

Sham and then tDCS; tDCS intervention

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.

Sham and then tDCS

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• National Institute on Aging (NIA): collaborator
• Hebrew SeniorLife: lead

Study Sites (1)

Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife

Boston, Massachusetts, 02131, United States

Location

MeSH Terms

Conditions

Gait Disorders, Neurologic; Mobility Limitation

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• On-Yee Lo, Ph.D.

  Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2023
• First Posted: August 23, 2023
• Study Start: June 3, 2024
• Primary Completion: November 20, 2025
• Study Completion: November 20, 2025
• Last Updated: January 21, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will be available when the data are unblinded.
• 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.

Locations

US (1)