Balance Training + Spinal Stimulation for Aging

Overseen By Jungyun Hwang, PhD

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must not be taking: Benzodiazepines, Anticholinergics, GABAergics

Disqualifiers: Neurological disorders, Severe arthritis, Cardiovascular disease, others

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

Compensation: Varies

Number of Visits: 7

Duration: 2 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining balance training with electrical stimulation of the lower spine can improve balance and walking in older adults. Researchers seek to discover if this approach reduces the risk of falls and enhances quality of life. Participants will receive either real electrical stimulation (Spinal Active tsDCS) or a sham version (Spinal Sham tsDCS) while performing balance exercises. Individuals who walk slowly or have noticeable balance issues might be suitable for this study. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance mobility and safety for older adults.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not take medications affecting the central nervous system, such as benzodiazepines, anti-cholinergic medication, and GABAergic medication. If you are on these medications, you may need to stop taking them to participate.

What prior data suggests that this method is safe for improving balance and walking in older adults?

Research has shown that spinal stimulation, specifically transcutaneous spinal direct current stimulation (tsDCS), is generally safe for older adults. In past studies, older adults handled tsDCS well, with no major side effects reported. For example, one study found that tsDCS improved balance and walking in older adults without causing significant side effects. Another study demonstrated that combining tsDCS with balance training was safe and enhanced movement in individuals with spinal cord issues.

These findings suggest that tsDCS is a well-tolerated treatment option for older adults. However, as with any medical treatment, individual experiences may differ, so discussing potential risks with a healthcare provider is advisable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about spinal stimulation combined with balance training for aging because it offers a novel approach to improving balance and stability, potentially reducing fall risk in older adults. Unlike traditional physical therapy or pharmacological interventions, this technique uses transcutaneous spinal direct current stimulation (tsDCS), which involves non-invasive electrical stimulation over the lumbar region to enhance neuromuscular function during balance exercises. This method is distinctive because it integrates a targeted electrical stimulus with active balance training, potentially leading to quicker and more effective improvements in balance compared to standard treatments.

What evidence suggests that this trial's treatments could be effective for improving balance and walking in older adults?

This trial will compare the effects of spinal transcranial direct current stimulation (tsDCS) combined with balance exercises in older adults. Research has shown that combining gentle electrical brain stimulation techniques like tsDCS with balance exercises can improve physical abilities. Participants in one arm of this trial will receive active tsDCS, which may enhance dynamic balance, the ability to stay steady while moving. In older adults, using tsDCS along with exercise has improved balance and walking endurance, potentially reducing the risk of falls and improving quality of life. The treatment sends mild electrical signals to the spinal cord, which may enhance its response and improve communication within the body. While more research is needed, early results are promising for using this combination to support better balance and mobility. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for older adults aged 65 to 95 with walking speeds slower than 1.0 m/s and balance scores below a certain threshold, who have controlled blood pressure, adequate vision, and no significant cognitive impairment.

Inclusion Criteria

My blood pressure is below 180/100 mmHg.

My vision is better than or equal to 20/70.

My cognitive function is normal, with a MoCA score of 26 or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo five sessions of balance training combined with either active or sham tsDCS over a 2-week period

2 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1-day and 10-day post-intervention

2 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Balance Training
• Spinal Active tsDCS
• Spinal Sham tsDCS

Trial Overview The study investigates if electrical stimulation of the spinal lumbar regions can improve balance and walking in aging individuals compared to sham (fake) stimulation, alongside dynamic balance training.

How Is the Trial Designed?

Group I: Active tsDCS treatment Active Control 2 Interventions

Participants will receive 30 minutes of continuous 2.5-mA tsDCS over the lumbar regions while engaging in a 30-minute complex balance task during each intervention session over a period of 2 weeks (every other day), totaling 5 intervention visits.

Group II: Sham tsDCS control Placebo Group 2 Interventions

Participants will receive 3 minutes of 2.5-mA tsDCS over the lumbar regions while engaging in a 30-minute complex balance task during each intervention session over a period of 2 weeks (every other day), totaling 5 intervention visits.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a study of 32 women aged 62 to 75, all three exercise programs (stair climbing, electrostimulation, and a combination of both) improved dynamic balance after 6 weeks, indicating that physical activity is beneficial for balance in older adults.

However, the stair climbing group showed a greater reliance on visual information for balance control, suggesting that voluntary exercise may be more effective than electrostimulation in enhancing balance strategies among the elderly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effects of electrical stimulation superimposed on muscular voluntary contraction in postural control in elderly women. Paillard, T., Lafont, C., Soulat, JM., et al.[2016]

Balance and functional strength training, including Tai Chi, significantly reduced the rate of falls and improved physical functioning in adults aged 65 and older, based on an overview of 5 systematic reviews involving 15,890 participants.

The training showed potential benefits for health-related quality of life, but the evidence was uncertain regarding falls requiring hospitalization, and only one serious adverse event was reported, indicating a generally safe intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Balance and functional training and health in adults: an overview of systematic reviews. McLaughlin, EC., El-Kotob, R., Chaput, JP., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9130633/

Walking and Balance Outcomes Are Improved Following Brief ... Walking and Balance Outcomes Are Improved Following Brief Intensive Locomotor Skill Training but Are Not Augmented by Transcranial Direct ...

2. frontiersin.org frontiersin.org/journals/aging-neuroscience/articles/10.3389/fnagi.2022.837467/full

A Pilot Randomized Controlled Trial in Older Adults This study investigated locomotor learning of a complex terrain walking task in older adults, when combined with two adjuvant interventions.

3. mdpi.com mdpi.com/2227-9032/13/11/1263

Enhancing Balance and Walking Endurance in Older Adults This study explores the potential of transcranial direct current stimulation (tDCS) as an adjunct to balance training to enhance physical performance in the ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0987705320300149

The effect of transcranial direct current stimulation on ... The results showed that anodal tDCS (a-tDCS) of primary motor cortex may improve dynamic balance in young healthy individuals. In older adults, a-tDCS of ...

5. medicaljournalssweden.se medicaljournalssweden.se/jrm/article/view/42353/50078

Tele-rehabilitation using transcranial direct current ... This study explored the effects of home-based transcranial direct current stimulation combined with exercise on motor and sensory function, spasticity, ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/35309891/

A Pilot Randomized Controlled Trial in Older Adults This study investigated locomotor learning of a complex terrain walking task in older adults, when combined with two adjuvant interventions.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12380813/

The effect of transcranial direct current stimulation on static ... Compared to control conditions, tDCS significantly improved following outcomes in older adults, static postural stability index (APSIstatic: p < ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1094715925000078

Safety and Effectiveness of Multisite Transcutaneous ... This study showed that tSCS combined with ABT is safe, feasible, and effective in adults with chronic SCI ranging from the cervical to thoracic level when ...

9. ctv.veeva.com ctv.veeva.com/study/spinal-networks-of-balance-learning-and-retention-in-older-adults

Spinal Networks of Balance Learning and Retention in Older ... These initial findings support the enhanced efficacy of locomotor learning during a single session when combined with tsDCS in older adults.