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

NCT ID: NCT06779188

Last Updated: 2025-05-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-06
• Study Completion Date: 2026-05-31

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.

Conditions

Aging; Balance Deficits

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment group

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 Type: EXPERIMENTAL

Transcranial Magnetic Stimulation

Intervention Type: 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.

Sham group

Participants in this group will receive sham (placebo) TMS once daily, 5 days a week.

Group Type: SHAM_COMPARATOR

Transcranial Magnetic Stimulation Sham

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Houston

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Weinberg Medical Physics LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Center for Neuromotor and Biomechanics Research at the University of Houston

Houston, Texas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Pranav J Parikh, MBBS, PhD

Role: CONTACT

pjparikh2@uh.edu

713-743-0503

Facility Contacts

Pranav J Parikh, MBBS, PhD

Role: primary

pjparikh2@uh.edu

713-743-0503

Other Identifiers

R41AG085838

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00004556

Identifier Type: -

Identifier Source: org_study_id