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

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.

Study Overview

• Status: Recruiting
• Conditions: Aging; Balance Deficits
• Intervention / Treatment: Device: Transcranial Magnetic Stimulation; Device: Transcranial Magnetic Stimulation Sham

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.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Pranav J Parikh, MBBS, PhD; Phone Number: 713-743-0503; Email: pjparikh2@uh.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77204
      • Recruiting
      • The Center for Neuromotor and Biomechanics Research at the University of Houston
      • Contact: Pranav J Parikh, MBBS, PhD; Phone Number: 713-743-0503; Email: pjparikh2@uh.edu
      • Principal Investigator: Pranav J Parikh, MBBS, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	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.
Sham Comparator: Sham group; Participants in this group will receive sham (placebo) TMS once daily, 5 days a week.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Electroencephalography functional connectivity	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.	Before and immediately-after the intervention and at 3- month follow-up
miniBESTest	It provides a comprehensive assessment of anticipatory and reactive postural control, sensory orientation, and dynamic gait.	Before and immediately-after the intervention and at 3- month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Activities-Specific Balance Confidence scale (Aim 2)	It consists of 16 items describing different situations that might lead to a loss of balance. For each time, scoring is done from 0-100 (0 is no confidence and 100 is full confidence). The total score is calculated by adding up all the individual item scores and dividing by 16. The Activities-Specific Balance Confidence total score is known to predict falls in elderly subjects.	Before and immediately-after the intervention and at 3- month follow-up
Root mean square of foot center of pressure on the balance task	It is calculated from the ground reaction forces.	Before and immediately-after the intervention and at 3- month follow-up

Collaborators and Investigators

• Sponsor: Weinberg Medical Physics LLC
• Collaborators: National Institute on Aging (NIA); University of Houston

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2025
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 14, 2025
• First Posted (Actual): January 16, 2025

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 14, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Treatment; Elderly; Balance; TMS; Brain stimulation
• Other Study ID Numbers: STUDY00004556; R41AG085838 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No