RECRUITING Early Phase 1 ClinicalTrials.gov

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

Sponsor: Weinberg Medical Physics LLC • ClinicalTrials.gov ID: NCT06779188

Registry updated: 2026-08-28

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Description

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.

Interventions

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

Eligibility criteria

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.

Conditions

Aging Balance Deficits

Locations

The Center for Neuromotor and Biomechanics Research at the University of Houston — Houston, Texas, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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