Actively Recruiting

Early Phase 1
Age: 65Years +
All Genders
ID06779188

Treating Balance Impairment in Older Adults Using TMS-Induced Brain Connectivity Changes

Led by Weinberg Medical Physics LLC · Updated on 2025-05-15

30

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

Sponsors

W

Weinberg Medical Physics LLC

Lead Sponsor

U

University of Houston

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are investigating whether using a technique called transcranial magnetic stimulation (TMS), which uses magnets to affect brain activity, can help improve balance in older adults who have balance problems and a history of falls. The study aims to understand how TMS changes communication between different brain areas and whether it can improve balance ability compared to a placebo treatment. This early phase study focuses on adults aged 65 and older who have experienced falls, as balance impairment greatly increases fall risk and can reduce quality of life. Participants will be randomly assigned to one of two groups: one group will receive real TMS treatment, and the other will receive sham (placebo) TMS. Both interventions are delivered once daily, five days a week, over a four-week period. Each participant will also undergo an MRI scan and baseline assessments of brain connectivity using electroencephalography (EEG) and balance testing. EEG and balance assessments will be repeated immediately after the intervention and again three months later to track any changes. During the study, participants will visit the laboratory three times for assessments before, immediately after, and three months following the intervention. Researchers will measure brain connectivity through EEG and assess balance using the miniBESTest and other balance confidence and foot pressure tests. The study monitors participants closely for safety and effectiveness of the TMS intervention over the course of several months. Total study participation spans at least three months after completing the treatment sessions.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 65Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide informed consent
  • All ethnic groups
  • Age 65 years or older
  • History of 2 or more non-injury falls or at least 1 injury fall in the past year
  • No dementia or uncontrolled psychiatric disorders
  • Able to walk and stand independently for at least 5 minutes without assistance
  • Willingness to undergo MRI and participate in the 4-week intervention and all laboratory assessments before, immediately after, and 3 months after the intervention
Not Eligible

You will not qualify if you...

  • Unable to provide informed consent
  • Non-English speaking
  • Contraindications to TMS (e.g., pregnancy, metal in brain/skull, neurostimulator, pacemaker, infusion device, certain psychiatric medications)
  • Unintentional weight loss of 10 pounds or more in the past year
  • Severe uncontrolled hypertension or uncontrolled diabetes
  • Poor cognitive status (MoCA score less than 26)
  • Untreated depression or Geriatric Depression Scale score greater than 7
  • History of limb amputation
  • Planned surgery within 3 months
  • History of chemotherapy or planned chemotherapy within 6 months or active cancer
  • Severe osteoporosis with fracture
  • Pregnant or possible pregnancy
  • Chronic inflammatory, autoimmune, or infectious diseases such as tuberculosis, HIV, rheumatoid arthritis, lupus, hepatitis B or C
  • Illicit drug use
  • Use of medications that increase fall risk (sedatives, hypnotics, anti-cholinergic, benzodiazepines, antidepressants)
  • Intracranial bleeds visible on recent CT or MRI scans

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Baseline Assessments

Duration - 1 week

Participants undergo baseline assessments including MRI scan, brain connectivity using electroencephalography (EEG), and balance assessment.

1 visit (in-person)

Implementation

Duration - 4 weeks

Participants receive transcranial magnetic stimulation (TMS) or sham TMS once daily, 5 days a week, for 4 weeks to improve balance and brain connectivity.

20 visits (in-person, daily on weekdays)

Post-Intervention Assessments

Duration - 1 week

Immediately following the intervention, brain connectivity and balance assessments are repeated.

1 visit (in-person)

Follow-up

Duration - 1 day

Participants return for follow-up assessments of brain connectivity and balance 3 months after the intervention.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

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

Houston, Texas, United States, 77204

Actively Recruiting

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Research Team

P

Pranav J Parikh, MBBS, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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