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

Sponsor

Hebrew SeniorLife (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06008431

Collaborator

National Institute on Aging (NIA) (NIH)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Fall Gait, Unsteady Mobility Limitation	Device: Transcranial direct current stimulation (tDCS) (active) Device: Transcranial direct current stimulation (tDCS) (Sham)	N/A

Detailed Description

This is a randomized controlled trial to examine the effecacy of a non-invasive brain stimulation intervention of tDCS to improve unsteady gait in older adults. We 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 stimulaton 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 Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2024

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

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 deault 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) (active) The tDCS montage is developed to modulate the functional connectivity between the dorsal attention network and the deault network. 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.

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 deault 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) (active)

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

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.

Outcome Measures

Primary Outcome Measures

Gait variability [Baseline, Immediate post-intervention, 1 month follow up]
This measure is captured by both Mobility Lab (APDM Inc) and the smartphone App. Gait variability is defined as the coefficient of variation to validated stride times.

Secondary Outcome Measures

Gait speed [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.
Dual-task gait performance [Baseline, Immediate post-intervention, 1 month follow up]
Participants will be asked to walk under two conditions: 1) walk at a comforable, 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.
Accuracy (d prime) on the gradual onset continuous performance task (gradCPT) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 disordders.
Self-reported pain or lower extremity defomity 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, DVT, 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 sefating 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