Examining the Effects of Theta Burst TMS on Brain Connectivity and Balance Ability in Older Adults With Balance Problems

NCT06779188 · tracked via the Priya Life Science USA tracker

Sponsor

Weinberg Medical Physics LLC

Phase

Early Phase 1

Started

2025-05-06

Last updated

2026-08-28

Condition(s) studied

AgingBalance Deficits

Investigational drug(s) / intervention(s)

Transcranial Magnetic StimulationTranscranial Magnetic Stimulation Sham

Transcranial Magnetic Stimulation: TMS (in the form of theta burst stimulations) will be delivered over Supplementary Motor Area while the subject is seated in the Treatment group. TMS is capable to induce neuroplastic facilitatory changes in the brain that last beyond the duration of stimulation. TMS will be delivered once daily, 5 days per week, for 4 weeks.

Transcranial Magnetic Stimulation Sham: Sham TMS will be delivered in the sham group using a sham coil once daily, 5 days per week, for 4 weeks.

Study summary

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

Sex

ALL

Min age

65 Years

Max age

—

Healthy volunteers

Inclusion Criteria: a) Able to provide informed consent b) All ethnic groups c) \>65 years of age d) ≥2 non-injury falls or ≥1 injury fall in the past year \[17\]-\[21\] e) Absence of dementia/uncontrolled psychiatric disorder h) Able to walk and stand for 5 min continuously independently without assistance (i.e., cane, walker, ankle foot orthotics, electric scooter). i) Willingness to undergo MRI, participate in the 4-weeks intervention AND in the laboratory studies before, immediately-after, and 3-month after the intervention. Exclusion Criteria: 1. Inability to provide informed consent. 2. Non-English speaking. 3. Have contraindications to TMS based on TMS Adult Safety Screen (e.g., pregnancy, metal in the brain/skull, neurostimulator, pacemaker, infusion device, medication to treat mental illness) 4. Unintentional weight loss of ≥10 pounds over the past year. 5. Severe uncontrolled hypertension, or uncontrolled diabetes. 6. Poor cognitive status (Montreal Cognitive Assessment (MoCA) score ≥ 26) 7. Untreated depression or Geriatric Depression Scale score on 15 item scale \>7 8. History of limb amputation (upper or lower extremity) 9. Planned surgery in the next 3 months. 10. History of chemotherapy or planned chemotherapy in the next 6 months or active malignancy. 11. Severe osteoporosis, defined by diagnosis of osteoporosis with fracture. 12. Pregnant or have a chance of being pregnant. 13. Chronic inflammatory condition, autoimmune disease or infectious processes such as active tuberculosis, Human Immunodeficiency Virus, Rheumatoid arthritis, systemic lupus erythematosus, acute or chronic hepatitis B or C. 14. Illicit drug use 15. Use of medications that may increase the risk of falling: * Sedatives * Hypnotics * Anti-cholinergic * Benzodiazepines * Anti-depressants 16. Intracranial bleeds visible on their most recent CT or MRI scans.

Primary outcome measure(s)

Electroencephalography functional connectivity — Before and immediately-after the intervention and at 3- month follow-up
Electroencephalography (EEG) will be used to measure the brain activity. The brain circuitry responsible for balance will be evaluated with EEG projected onto individual anatomical MRI. Directed functional connectivity between two regions of activation will be computed. The higher the functional connectivity coefficient, the stronger the connectivity.
miniBESTest — Before and immediately-after the intervention and at 3- month follow-up
It provides a comprehensive assessment of anticipatory and reactive postural control, sensory orientation, and dynamic gait.

Trial sites (1)

Facility	City	Region	Status
The Center for Neuromotor and Biomechanics Research at the University of Houston	Houston	Texas	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06779188 on ClinicalTrials.gov ↗ ← All trials in the USA