The Center for Neuromotor and Biomechanics Research at the University of Houston
Houston, Texas, 77204, United States
Location status: Recruiting
Location contact
Pranav J Parikh, MBBS, PhD
CONTACT
Pranav J Parikh, MBBS, PhD
PRINCIPAL_INVESTIGATOR
NCT Number: NCT06779188
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.
Interested in participating?
Request Info65 year and older
All sexes
Interventional
Early Phase 1
Houston, Texas, 77204, United States
Location status: Recruiting
Pranav J Parikh, MBBS, PhD
CONTACT
Pranav J Parikh, MBBS, PhD
PRINCIPAL_INVESTIGATOR
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
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 TMS will be delivered in the sham group using a sham coil once daily, 5 days per week, for 4 weeks.
Time frame: Before and immediately-after the intervention and at 3- month follow-up
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
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
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
It is calculated from the ground reaction forces.
Contact information is provided by the study sponsor or research team.
Weinberg Medical Physics LLC
Industry
Treating Balance Impairment of the Elderly With TMS-induced Brain Connectivity
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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