Clinical trial NCT06779188: Examining the Effects of Theta Burst TMS on Brain Connectivity and Balance Ability in Older Adults With Balance Problems
Official title: Treating Balance Impairment of the Elderly With TMS-induced Brain Connectivity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Aging
Balance Deficits
Keywords: TMS
Balance
Brain stimulation
Elderly
Treatment
Lead sponsor: Weinberg Medical Physics LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Houston
name: National Institute on Aging (NIA)
First posted: 2025-01-16
Enrollment: 30
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Electroencephalography functional connectivity
timeFrame: Before and immediately-after the intervention and at 3- month follow-up
measure: miniBESTest
timeFrame: Before and immediately-after the intervention and at 3- month follow-up
Secondary outcomes:
measure: Activities-Specific Balance Confidence scale (Aim 2)
timeFrame: Before and immediately-after the intervention and at 3- month follow-up
measure: Root mean square of foot center of pressure on the balance task
timeFrame: Before and immediately-after the intervention and at 3- month follow-up
Other outcomes:
Locations:
city: Houston
country: United States
facility: The Center for Neuromotor and Biomechanics Research at the University of Houston
state: Texas
Study officials:
References: