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

Primary Purpose

Fall, Gait, Unsteady, Mobility Limitation

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial direct current stimulation (tDCS) (active)
Transcranial direct current stimulation (tDCS) (Sham)
Sponsored by
Hebrew SeniorLife
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fall focused on measuring transcranial direct current stimulation (tDCS), transcranial electrical stimulation (tES), Non-invasive brain stimulation (NIBS), Falls, Gait Variability, Sustained Attention, Dorsal Attention Network, Default Network

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

tDCS intervention

Sham and then tDCS

Arm Description

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

Five, once-daily, 20-min sessions of sham in week one followed by five, once-daily, 20-min sessions of tDCS in week two.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Gait speed
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
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.
Accuracy (d prime) on the gradual onset continuous performance task (gradCPT)
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.

Full Information

First Posted
August 18, 2023
Last Updated
September 5, 2023
Sponsor
Hebrew SeniorLife
Collaborators
National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT06008431
Brief Title
Non-invasive Brain Stimulation to Improve Unsteady Gait in Older Adults (StimGait)
Official Title
Modulating Brain Networks to Reduce Gait Variability in Older Adults at Risk of Falling
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebrew SeniorLife
Collaborators
National Institute on Aging (NIA)

4. Oversight

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
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
tDCS intervention
Arm Type
Experimental
Arm Description
Ten, once-daily, 20-min sessions of tDCS will be provided over two consecutive weeks.
Arm Title
Sham and then tDCS
Arm Type
Sham Comparator
Arm Description
Five, once-daily, 20-min sessions of sham in week one followed by five, once-daily, 20-min sessions of tDCS in week two.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (tDCS) (active)
Intervention Description
The tDCS montage is developed to modulate the functional connectivity between the dorsal attention network and the default network.
Intervention Type
Device
Intervention Name(s)
Transcranial direct current stimulation (tDCS) (Sham)
Intervention Description
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 Outcome Measure Information:
Title
Gait variability
Description
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.
Time Frame
Baseline, Immediate post-intervention, 1 month follow up
Secondary Outcome Measure Information:
Title
Gait speed
Description
This measure is captured by Mobility Lab (APDM InC). Gait speed id defined by the time one takes to walk a specified distance.
Time Frame
Baseline, Immediate post-intervention, 1 month follow up
Title
Dual-task gait performance
Description
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.
Time Frame
Baseline, Immediate post-intervention, 1 month follow up
Title
Accuracy (d prime) on the gradual onset continuous performance task (gradCPT)
Description
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.
Time Frame
Baseline, Immediate post-intervention, 1 month follow up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
On-Yee Lo, Ph.D.
Phone
617-931-5331
Email
AmyLo@hsl.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
On-Yee Lo, Ph.D.
Organizational Affiliation
Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
On-Yee Lo, Ph.D.
Phone
617-931-5331
Email
AmyLo@hsl.harvard.edu
First Name & Middle Initial & Last Name & Degree
On-Yee Lo, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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