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

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age65+
SponsorWeinberg Medical Physics LLC

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Treatment groupExperimental treatment 1 intervention
Group B: Sham groupSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Before and immediately-after the intervention and at 3- month follow-up
2

miniBESTest

It provides a comprehensive assessment of anticipatory and reactive postural control, sensory orientation, and dynamic gait.

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

Secondary outcomes

1

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.

Time frame
Before and immediately-after the intervention and at 3- month follow-up
2

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

It is calculated from the ground reaction forces.

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Weinberg Medical Physics LLC

Lead sponsor

University of Houston

Collaborator

National Institute on Aging (NIA)

Collaborator