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Behavioural Intervention

Non-invasive Brain Stimulation for Gait Instability

N/A
Waitlist Available
Led By On-Yee Lo, Ph.D.
Research Sponsored by Hebrew SeniorLife
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Aged 65 and above
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
Must not have
Legal blindness, visual impairments that cannot be corrected with glasses, contact lenses, medicine, or surgery
Current treatment for congestive heart failure, angina, uncontrolled arrythmia, deep vein thrombosis, or other uncontrolled cardiovascular events
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, immediate post-intervention, 1 month follow up
Awards & highlights

Summary

This trial seeks to improve walking and cognitive performance in older adults with a non-invasive brain stimulation technique.

Who is the study for?
This trial is for adults aged 65 or older who can walk on their own and have a high variability in their walking pattern, which may increase the risk of falls. They must speak English and be able to walk continuously for at least one minute. People with severe pain affecting walking, recent serious illnesses, significant cognitive impairment, certain neurological disorders, uncontrolled heart conditions, active cancer treatment, psychiatric issues or those taking sedating medications are not eligible.Check my eligibility
What is being tested?
The StimGait trial is testing non-invasive brain stimulation called tDCS to see if it can improve walking steadiness in older adults. Participants will receive either the real tDCS treatment or a sham (fake) version without knowing which one they're getting. The study aims to see how this affects brain activity related to movement and attention.See study design
What are the potential side effects?
tDCS is generally considered safe but might cause mild side effects like itching or tingling under the electrode during stimulation, headache after treatment sessions, fatigue or nausea. Serious side effects are rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 65 years old or older.
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My walking pattern is irregular, with stride times varying significantly.
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I can walk on my own for at least 1 minute without stopping.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am legally blind or have vision problems that can't be fixed.
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I am not currently being treated for serious heart conditions or blood clots.
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I have been diagnosed with a long-term balance disorder.
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I have a psychiatric condition like major depression or schizophrenia.
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I am currently receiving chemotherapy or radiation for my cancer.
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I have a neurological condition like Parkinson's, MS, stroke, or a brain tumor.
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I have pain or a leg deformity that makes it hard for me to walk.
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I haven't been hospitalized or needed active treatment for a sudden illness in the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, immediate post-intervention, 1 month follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, immediate post-intervention, 1 month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Gait variability
Secondary outcome measures
Accuracy (d prime) on the gradual onset continuous performance task (gradCPT)
Dual-task gait performance
Gait speed

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: tDCS interventionExperimental Treatment1 Intervention
Ten, once-daily, 20-min sessions of tDCS will be provided over two consecutive weeks.
Group II: Sham and then tDCSPlacebo Group2 Interventions
Five, once-daily, 20-min sessions of sham in week one followed by five, once-daily, 20-min sessions of tDCS in week two.

Find a Location

Who is running the clinical trial?

Hebrew SeniorLifeLead Sponsor
46 Previous Clinical Trials
270,719 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,704 Previous Clinical Trials
28,033,227 Total Patients Enrolled
On-Yee Lo, Ph.D.Principal InvestigatorHinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife
~12 spots leftby Dec 2024
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