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

NCT06779188 | Recruiting Early Phase 1

• 2 other identifiers: STUDY00004556R41AG085838
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Aging; Balance Deficits

Keywords

TMS; Balance; Brain stimulation; Elderly; Treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Activities-Specific Balance Confidence scale (Aim 2)

  Before and immediately-after the intervention and at 3- month follow-up

• Root mean square of foot center of pressure on the balance task

  Before and immediately-after the intervention and at 3- month follow-up

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Sham group

SHAM COMPARATOR

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

Device: Transcranial Magnetic Stimulation Sham

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.

Treatment group

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.

Sham group

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to provide informed consent.
• Non-English speaking.
• 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)
• Unintentional weight loss of ≥10 pounds over the past year.
• Severe uncontrolled hypertension, or uncontrolled diabetes.
• Poor cognitive status (Montreal Cognitive Assessment (MoCA) score ≥ 26)
• Untreated depression or Geriatric Depression Scale score on 15 item scale \>7
• History of limb amputation (upper or lower extremity)
• Planned surgery in the next 3 months.
• History of chemotherapy or planned chemotherapy in the next 6 months or active malignancy.
• Severe osteoporosis, defined by diagnosis of osteoporosis with fracture.
• Pregnant or have a chance of being pregnant.
• 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.
• Illicit drug use
• Use of medications that may increase the risk of falling:

Sponsors & Collaborators

• Weinberg Medical Physics LLC: lead
• University of Houston: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

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

Houston, Texas, 77204, United States

RECRUITING

MeSH Terms

Interventions

Transcranial Magnetic Stimulation

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Central Study Contacts

Pranav J Parikh, MBBS, PhD

CONTACT

713-743-0503; pjparikh2@uh.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants and their caregivers will not know whether they are receiving TMS or sham. The outcome assessors will be blinded to the group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 16, 2025
• Study Start: May 6, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

US (1)