Brain Stimulation for Balance Disorder

(BSFS Trial)

Overseen By Junhong Zhou, PhD

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hebrew SeniorLife

Must not be taking: Neuro-active drugs, Antipsychotics

Disqualifiers: Uncontrolled diabetes, Dementia, Parkinson's, others

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

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new technique called transcranial direct current stimulation (tDCS), a type of noninvasive brain stimulation. The researchers aim to determine if tDCS can improve balance and mobility in older adults with reduced foot sensation. The trial includes two groups: one will receive the actual tDCS treatment, while the other will receive a sham (fake) treatment for comparison. Participants aged 65 and older who feel unsteady or have difficulty standing and walking due to mild-to-moderate foot sensation issues are being sought. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you use neuro-active drugs (like sedatives or anti-psychotics) or have uncontrolled hypertension requiring three or more medications, you may not be eligible to participate.

What prior data suggests that transcranial direct current stimulation is safe for improving balance in older adults?

Research has shown that transcranial direct current stimulation (tDCS) is generally safe. One study found that typical tDCS methods do not cause serious side effects. Some individuals might experience mild sensations, such as tingling under the electrodes, but these are not harmful. Another study on using tDCS at home for 10 weeks found it safe and well-tolerated. Overall, tDCS appears to be a safe method to help improve balance and mobility in older adults. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for balance disorders, which often involve physical therapy or medication, transcranial direct current stimulation (tDCS) is unique because it uses a non-invasive electrical current to stimulate specific areas of the brain. This method can potentially enhance brain plasticity, offering a novel way to improve balance. Researchers are excited about tDCS because it targets the root neurological causes of balance issues, which could lead to more effective and faster-acting improvements than traditional approaches. Additionally, tDCS is painless and has minimal side effects, making it an attractive option for patients who cannot tolerate medication.

What evidence suggests that transcranial direct current stimulation is effective for balance disorder?

Research has shown that transcranial direct current stimulation (tDCS) can improve balance. Studies have found that tDCS aids in controlling posture, which is crucial for maintaining stability and preventing falls. Reviews of previous research suggest that tDCS is a promising treatment for enhancing balance, even after just a few sessions. It has proven effective in older adults, who often struggle with balance. In this trial, participants in the tDCS group will receive the real tDCS intervention, while those in the sham group will receive sham stimulation as a control. This suggests that tDCS could enhance balance and movement in individuals with sensory issues in their feet. ^{5 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for older adults aged 65 or above who feel unsteady or have difficulty standing and walking, and have mild-to-moderate foot-sole sensation loss. They should be able to feel a 75g touch but not a lighter 10g touch on their feet.

Inclusion Criteria

I often feel unsteady or have trouble walking.

I can feel a 75g touch but not a 10g touch on the sole of my foot.

I am 65 years old or older.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial direct current stimulation (tDCS) to test its effects on foot sole sensation, balance, and mobility

1 week

Daily visits for intervention

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcranial Direct Current Stimulation

Trial Overview

The study tests if brain stimulation can improve foot sensation, balance, and mobility in older adults with sensory deficits. It involves noninvasive transcranial direct current stimulation (tDCS) compared to an inactive sham treatment.

How Is the Trial Designed?

Group I: tDCS group Experimental Treatment 1 Intervention

Participants in this arm will receive the real tDCS intervention.

Group II: sham group Placebo Group 1 Intervention

Participants in this arm will receive the sham stimulation as control.

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

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10594930/

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.

2.

frontiersin.org

frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2020.00275/full

The Effects of Transcranial Direct Current Stimulation ...

We completed a comprehensive systematic review and meta-analysis to assess the efficacy of tDCS on balance control in this population.

3.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S1568163722001787

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 ...

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04341220

Effects of Transcranial Direct Current Stimulation on ...

Transcranial direct current stimulation (TDCS) improves postural control in children and adults with and without neurological disorders, however, additive ...

5.

mdpi.com

mdpi.com/2076-3425/14/10/1021

Transcranial Direct Current Stimulation for Improving ...

This review aims to summarize and compare the available evidence of the tDCS on improving balance in the older adults without neurological disorders and the ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5007190/

Safety of transcranial Direct Current Stimulation: Evidence ...

To date, the use of conventional tDCS protocols in human trials (≤40 min, ≤4 mA, ≤7.2 Coulombs) has not produced any reports of a Serious Adverse Effect or ...

7.

sciencedirect.com

sciencedirect.com/science/article/pii/S2590109523000447

Feasibility and Safety of Sequential Transcranial Direct ...

Together, 2 out of 6 (33.3%) participants reported some type of side effects across their stimulation sessions. Sensations under electrodes were reported in ...

8.

nature.com

nature.com/articles/s41591-024-03305-y

Home-based transcranial direct current stimulation ...

A 10-week home-based tDCS treatment with remote supervision in MDD showed high efficacy, acceptability and safety.

9.

thelancet.com

thelancet.com/journals/laneur/article/PIIS1474-4422(25)00044-4/abstract

Safety and efficacy of transcranial direct current stimulation ...

tDCS at doses of 2 mA or 4 mA, in addition to mCIMT, did not lead to further reduction in motor impairment in patients 1–6 months after stroke, ...