Transcranial Magnetic Stimulation for Balance Disorder

Overseen By Pranav J Parikh, MBBS, PhD

Age: 65+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Weinberg Medical Physics LLC

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

Disqualifiers: Uncontrolled hypertension, Diabetes, Dementia, others

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

Compensation: Varies

Number of Visits: 23

Duration: 4 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether using magnets on the brain can help older adults with balance issues. It aims to determine if transcranial magnetic stimulation (TMS) can improve balance and reduce falls. Participants will receive either real TMS or a placebo for four weeks. Suitable candidates are those over 65 who have experienced multiple falls without injury or one fall with injury in the past year and can walk and stand independently for five minutes. As an Early Phase 1 trial, this research focuses on understanding how TMS works in people, offering participants a chance to explore this innovative treatment.

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 use certain medications that may increase the risk of falling, such as sedatives, hypnotics, anti-cholinergic drugs, benzodiazepines, and anti-depressants.

What prior data suggests that transcranial magnetic stimulation is safe for treating balance disorders?

Research has shown that transcranial magnetic stimulation (TMS) is generally safe when administered by professionals. TMS has been studied for various conditions, including depression, and is usually well-tolerated with a favorable balance of risks and benefits. However, a small risk of seizures exists, so professionals always adhere to safety guidelines.

Theta burst TMS, a specific type of TMS, has also been tested in clinical settings. It has demonstrated positive results, particularly for treating depression, with few side effects. Experts manage the theoretical risk of seizures.

Overall, research on TMS suggests it is safe. Participants in studies have generally tolerated it well, with only mild side effects reported. Trial coordinators should be consulted if there are concerns or specific health conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about transcranial magnetic stimulation (TMS) for balance disorders because it offers a non-invasive approach that targets the brain directly. Unlike traditional treatments that might rely on medication or physical therapy, TMS uses magnetic fields to stimulate nerve cells, potentially improving balance by enhancing brain function. Additionally, the accelerated repetitive TMS used here might provide faster results, offering daily sessions that could lead to quicker improvements compared to other methods. This innovative technique could revolutionize how balance disorders are treated, making it a promising option for those seeking alternatives to existing therapies.

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

Research shows that theta burst transcranial magnetic stimulation (TMS) can improve movement and balance. In this trial, participants in the treatment group will receive TMS. Studies have found that TMS helps stroke patients regain motor skills and walk faster. It has also benefited those with depression, indicating a positive effect on brain function. While more research is needed, these findings suggest that TMS might help older adults with balance issues by enhancing brain communication. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for older adults who have trouble with balance. Participants will receive either real or sham (placebo) brain stimulation using magnets, known as TMS, over a period of 4 weeks and must visit the lab three times.

Inclusion Criteria

Able to provide informed consent

All ethnic groups

Absence of dementia/uncontrolled psychiatric disorder

Exclusion Criteria

Inability to provide informed consent

Pregnant or have a chance of being pregnant

Non-English speaking

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo MRI scan and baseline assessments of brain connectivity using EEG and balance assessment

1 week

1 visit (in-person)

Treatment

Participants receive TMS or placebo stimulation once daily, 5 days a week for 4 weeks

4 weeks

20 visits (in-person)

Post-Treatment Assessment

EEG and balance assessments are repeated immediately following the intervention period

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment with assessments at 3-month follow-up

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Theta Burst TMS

Trial Overview

The study tests whether transcranial magnetic stimulation (TMS), which uses magnets to manipulate brain activity, can improve communication between brain areas and enhance balance in older adults with balance issues.

How Is the Trial Designed?

Group I: Treatment group Experimental Treatment 1 Intervention

Participants in this group will receive transcranial magnetic stimulation (TMS) once daily, 5 days a week. TMS will be in the form of accelerated repetitive TMS. TMS is a safe technique when handled by experts.

Group II: Sham group Placebo Group 1 Intervention

Participants in this group will receive sham (placebo) TMS once daily, 5 days a week.

Who Is Running the Clinical Trial?

Weinberg Medical Physics LLC

Lead Sponsor

Trials

3

Recruited

60+

University of Houston

Collaborator

Trials

155

Recruited

48,600+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

In a study involving 17 healthy older participants, there was a significant correlation between changes in motor evoked potentials (MEPs) and early TMS-evoked EEG potentials (TEPs) after intermittent Theta Burst Stimulation (iTBS) to the left primary motor cortex, indicating a relationship between corticospinal and cortical excitability.

While MEP amplitudes increased significantly after iTBS, TEP responses did not show significant changes, suggesting that the effects of iTBS on cortical activity (as measured by TEPs) are more complex and may not directly reflect changes in motor output.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent theta-burst stimulation induces correlated changes in cortical and corticospinal excitability in healthy older subjects. Gedankien, T., Fried, PJ., Pascual-Leone, A., et al.[2019]

In a study of 165 pediatric participants aged 6 to 18, theta-burst TMS (TBS) demonstrated a similar safety profile to single- and paired-pulse TMS (sp/ppTMS), with no severe adverse effects reported.

The overall rate of adverse effects was 10.5% for TBS and 12.4% for sp/ppTMS, with most effects rated as minimal or mild, indicating that TBS is a safe option for further investigation in children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of theta burst stimulation vs. single and paired pulse transcranial magnetic stimulation: a comparative study of 165 pediatric subjects. Hong, YH., Wu, SW., Pedapati, EV., et al.[2020]

Theta burst stimulation (TBS) is a promising technique for altering brain excitability, with a review of studies showing that adverse events were mostly mild and occurred in only 5% of subjects, indicating a generally safe profile.

Despite its safety, TBS carries a theoretical higher risk of seizures compared to other stimulation methods, necessitating cautious application and further research into its dosing parameters to better understand seizure risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. Oberman, L., Edwards, D., Eldaief, M., et al.[2022]

Citations

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sciencedirect.com

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Connectivity-guided intermittent theta burst versus ... - Nature

MRI-neuronavigated cgiTBS and rTMS were equally effective in patients with treatment-resistant depression over 26 weeks.

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This study aimed to compare the efficacy and safety of intermittent theta-burst stimulation (iTBS) to the cerebellum or M1 on balance and motor recovery in ...

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3260517/

Safety of Theta Burst Transcranial Magnetic Stimulation

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nature.com

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Our results suggest that iTBS (L-DLPFC) had a favorable risk-benefit balance for the treatment of depression because iTBS (L-DLPFC) had a high ...

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sciencedirect.com

sciencedirect.com/science/article/pii/S2667174325001727

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TMS is efficacious and safe in BDep, with response and remission rates on par with unipolar depression. High and low frequency protocols on left ...

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frontiersin.org/journals/neurology/articles/10.3389/fneur.2025.1610016/full

Advances in theta-burst transcranial magnetic stimulation ...

Current clinical studies have confirmed that rTMS has significantly improved various neurological and psychiatric diseases, especially in ...

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Efficacy and safety of repetitive transcranial magnetic...

We included randomized, double-blind, sham-controlled trials investigating the efficacy of active repetitive transcranial magnetic stimulation ...