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

Trial Summary

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 data supports the effectiveness of the treatment Theta Burst TMS for balance disorder?

Research shows that intermittent theta-burst stimulation (iTBS) can improve balance and motor recovery in stroke patients by targeting brain areas like the cerebellum and primary motor cortex. Additionally, studies suggest that similar stimulation techniques can alter brain activity and improve balance function in various conditions, indicating potential benefits for balance disorders. ^{1 2 3 4 5}

Is theta burst transcranial magnetic stimulation (TBS) safe for humans?

Theta burst stimulation (TBS) is generally considered safe, with most adverse events being mild and occurring in about 5% of subjects. However, there is a theoretical risk of seizures, so it should be used with caution, especially since it is a relatively new technique. ^{3 5 6 7 8}

How does Theta Burst TMS treatment differ from other treatments for balance disorders?

Theta Burst TMS (transcranial magnetic stimulation) is unique because it uses magnetic fields to stimulate specific brain areas, like the cerebellum, to improve balance by reshaping brain networks. Unlike traditional therapies, it targets brain connectivity and can be combined with other rehabilitation methods for enhanced effects. ^{3 4 9 10 11}

What is the purpose of this trial?

The goal of this study is to learn if manipulating the brain using magnets works to treat balance impairment, a major cause of falls, in older adults with balance problems. The technique to manipulate the brain using magnets is known as transcranial magnetic stimulation or TMS. The main questions this study aims to answer are: * How does TMS change communication between brain areas? * Does TMS improve balance ability in older adults with balance problems? Researchers will compare the TMS group to a placebo group to see if manipulating the brain using magnets works to treat balance impairment. Participants will: * Receive TMS or placebo stimulation for 4 weeks. * Visit the laboratory for checkups and tests 3 times.

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Intermittent Theta-Burst Stimulation for Stroke: Primary Motor Cortex Versus Cerebellar Stimulation: A Randomized Sham-Controlled Trial. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Fronto-Parietal Brain Areas Contribute to the Online Control of Posture during a Continuous Balance Task. [2020]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Cerebellum-Cerebrum paired target magnetic stimulation on balance function and brain network of patients with stroke: A functional near-infrared spectroscopy pilot study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Brain network effects by continuous theta burst stimulation in mal de débarquement syndrome: simultaneous EEG and fMRI study. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Intermittent theta-burst stimulation induces correlated changes in cortical and corticospinal excitability in healthy older subjects. [2019]

6. Switzerland 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. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Safety of theta burst transcranial magnetic stimulation: a systematic review of the literature. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Safety Considerations for Cerebellar Theta Burst Stimulation. [2021]

9. Italy pubmed.ncbi.nlm.nih.gov

Cerebellar theta burst stimulation in stroke patients with ataxia. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Repetitive transcranial magnetic stimulation of the cerebellum improves ataxia and cerebello-fronto plasticity in multiple system atrophy: a randomized, double-blind, sham-controlled and TMS-EEG study. [2021]

11. United States pubmed.ncbi.nlm.nih.gov

Cerebellar Intermittent Theta-Burst Stimulation Combined with Vestibular Rehabilitation Improves Gait and Balance in Patients with Multiple Sclerosis: a Preliminary Double-Blind Randomized Controlled Trial. [2021]