NCT06779188

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

Treating Balance Impairment of the Elderly With TMS-induced Brain Connectivity

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Weinberg Medical Physics LLC · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Falls and fall-related injuries are a growing public health concern, particularly in regions of the world in which high proportions of the population are elderly. When these older adults are affected with neurological conditions such as stroke, neuropathies, Parkinson's disease, Alzheimer's disease, the risk for falls increases more than 3-fold. Falls and the resulting fear of falls can mark the beginning of a decline in function, participation in social activities, and independence, thus negatively affecting the quality of life. The aim of this project is to use electroencephalography-guided TMS to improve balance in elderly patients with a history of falls, through repair of (or compensation for) abnormal brain connectivity. The entire study will be done at the University of Houston in Dr. Parikh's laboratory (PI) in the Center for Neuromotor and Biomechanics laboratory (CNBR). The investigators will enroll 30 older adults with balance problems. Participants will be randomly and equally assigned to a treatment group (A) and a placebo (sham) group (B). Each participant will undergo a MRI scan at the MRI center. Participants will not be responsible for MRI-related costs. This will be followed by baseline assessments of brain connectivity using electroencephalography (EEG) and balance assessment. Participants in both groups will receive a 4-week long intervention (once daily, 5 days a week). Immediately following the intervention period, EEG and balance assessments will be repeated. A 3-month follow-up will be conducted.

Conditions

• Aging
• Balance Deficits

Interventions

Type	Name	Description
DEVICE	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.
DEVICE	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.

Timeline

• Start date: 2025-05-06
• Primary completion: 2026-05-01
• Completion: 2026-05-31
• First posted: 2025-01-16
• Last updated: 2025-05-15

Locations

1 site across 1 country: United States