30 Participants Needed

Non-invasive Brain Stimulation for Gait Instability

OL
Overseen ByOn-Yee Lo, PhD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to improve walking stability in older adults at risk of falling. It uses transcranial direct current stimulation (tDCS), a non-invasive technique that gently stimulates the brain, to determine if it can enhance brain function related to walking and attention. Participants will receive either tDCS or a sham treatment (a fake version used as a control) to compare effects. The trial seeks individuals aged 65 and above who can walk for at least one minute but have unstable walking patterns. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance mobility and quality of life for older adults.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have recently used sedating medications or changed your medication in the past month.

What prior data suggests that this non-invasive brain stimulation is safe for older adults?

Research has shown that transcranial direct current stimulation (tDCS) is usually easy for people to handle. One study found tDCS to be safe when combined with treadmill walking exercises, with no major side effects reported. Another study combined tDCS with physical therapy for older adults and found it safe and practical, even for those who were very frail. These findings suggest that tDCS might be a safe option for addressing walking problems. While these results are promising, individual experiences may vary.12345

Why are researchers excited about this trial?

Researchers are excited about transcranial direct current stimulation (tDCS) for gait instability because it offers a non-invasive way to potentially improve mobility. Unlike other treatments that may rely on medication or physical therapy, tDCS involves delivering a mild electrical current to the brain to enhance neural activity and improve walking stability. This technique is promising because it can be administered without surgery or drugs, reducing the risk of side effects and making it a more accessible option for patients. Additionally, tDCS sessions are relatively quick and can show results in a shorter period compared to traditional therapies.

What evidence suggests that transcranial direct current stimulation (tDCS) is effective for gait instability?

This trial will evaluate the effects of transcranial direct current stimulation (tDCS) on gait instability. Research has shown that tDCS can improve walking and balance. Studies suggest that tDCS is particularly beneficial for people with Parkinson's disease, enhancing their ability to walk and maintain balance. One study found that tDCS, when combined with treadmill exercises, increased walking speed. Although the quality of the evidence is considered low, these findings indicate that tDCS could be a promising therapy for improving walking and balance skills. Participants in this trial will receive either tDCS intervention or a combination of sham and then tDCS to assess its effectiveness.56789

Who Is on the Research Team?

OL

On-Yee Lo, Ph.D.

Principal Investigator

Hinda and Arthur Marcus Institute for Aging Research, Hebrew SeniorLife

Are You a Good Fit for This Trial?

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.
See 1 more

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.
See 11 more

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: tDCS interventionExperimental Treatment1 Intervention
Group II: Sham and then tDCSPlacebo Group2 Interventions

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:
🇪🇺
Approved in European Union as Transcranial direct current stimulation for:
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Approved in Canada as Transcranial direct current stimulation for:

Find a Clinic Near You

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+

Citations

Effectiveness of transcranial direct current stimulation on ...These results reveal that tDCS is an effective treatment for improving gait ability with a low quality of evidence.
Review Transcranial direct current stimulation for balance ...Balance improvements were evidenced regardless of the number of sessions and targeted area. In summary, tDCS is a promising therapy for balance rehabilitation ...
Effects of transcranial direct current stimulation alone and in ...Our results indicated that tDCS is significantly associated with gait and balance improvements among individuals with PD.
Multichannel Transcranial Direct Current Stimulation ...Our results of the primary outcome (gait velocity) indicate that tDCS with treadmill intervention is effective. The current study extends ...
Transcranial direct current stimulation for Parkinson's diseaseOne study (33%) found significant improvements after stimulating the sensorimotor cortex, whereas the other two studies (66%) detected no ...
Transcranial Direct Current Stimulation in the Treatment of ...The aim of this review is to analyse the evidence for the application of tDCS in the recovery of gait disturbance in stroke patients.
Effects of transcranial direct current stimulation combined ...The purpose of this review was to evaluate the available scientific evidence on the effects of tDCS combined with concurrent DT walking on mobility, gait and ...
Effects of combined transcranial direct current stimulation and ...tDCS combined with gait training compared with gait training alone did not make a statistically significant improvement in efficacy in patients ...
Feasibility and Safety of Sequential Transcranial Direct ...This study provides preliminary evidence about the feasibility, safety, and challenges to combine PT and tDCS in very frail older adults.
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