Non-invasive Brain Stimulation for Gait Instability

Overseen By On-Yee Lo, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Hebrew SeniorLife

Must not be taking: Sedatives, Antipsychotics, Hypnotics, Antidepressants

Disqualifiers: Cognitive impairment, Neurological disorders, Cardiovascular events, Cancer, Psychiatric illness, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 2 weeks

30 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

On-Yee Lo, Ph.D.

Principal Investigator

Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife

Eligibility Criteria

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.

Inclusion Criteria

I am 65 years old or older.

Ability to speak and read English

My walking pattern is irregular, with stride times varying significantly.

Exclusion Criteria

You do not have access to WiFi.

I have not had a heart attack or any heart surgery in the last 3 months.

I am legally blind or have vision problems that can't be fixed.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-intervention Assessments

Participants undergo assessments to establish baseline measures for gait variability, gait speed, dual-task gait performance, and cognitive performance

1 week

Treatment

Participants receive 10 sessions of tDCS or 5 sessions of sham followed by 5 sessions of tDCS over a 2-week period

2 weeks

10 visits (in-person)

Post-intervention Assessments

Participants undergo assessments to measure immediate effects of the intervention on gait variability, gait speed, dual-task gait performance, and cognitive performance

1 week

Follow-up

Participants are monitored for safety and effectiveness of the intervention at 1 month post-intervention

4 weeks

1 visit (in-person)

Treatment Details

Interventions

• Transcranial direct current stimulation (tDCS)

Trial Overview 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.

Participant Groups

Group I: tDCS intervention Experimental Treatment 1 Intervention

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

Group II: Sham and then tDCS Placebo Group 2 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.

Transcranial direct current stimulation (tDCS) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Transcranial direct current stimulation for:

• Stroke rehabilitation
• Depression
• Chronic pain

Approved in European Union as Transcranial direct current stimulation for:

• Stroke rehabilitation
• Major depressive disorder
• Chronic pain

Approved in Canada as Transcranial direct current stimulation for:

• Stroke rehabilitation
• Depression
• Chronic pain

Who Is Running the Clinical Trial?

Hebrew SeniorLife

Lead Sponsor

Trials

52

Recruited

273,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+