Assessing Fall Risk Using Transcranial Magnetic Stimulation and Quantitative Sensory Testing
NCT Number: NCT06480279
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Fall
Sponsor: Chulalongkorn University
Sex: ALL
Age: OLDER_ADULT
Enrollment: 150
Study Design: Observational Model: |Time Perspective: p
Start Date: 2024-05-16
Completion Date: 2025-05-16
Locations: Department of Medicine, Faculty of Medicine, Chulalongkorn University., Bangkok, 10330, Thailand

Summary:
The elderly are at high risk of falls due to neurophysiological changes, such as motor and sensory impairment, that occur with aging. The incidence of falls in older adults is high, with approximately 30% of adults over the age of 65 falling at least once per year. Falls can lead to serious consequences such as fractures, hospitalization, and loss of independence. The changes in neurophysiology have also been found to decrease balance control in aging people, leading to postural instability. It is well-known that postural balance is influenced by sensory inputs, including touch, proprioception, vision, and vestibular, as well as motor output such as motor controls. Impairments in these systems contribute to postural instability and an increased risk of falling in the elderly.

Primary Outcome Measures: Montreal Cognitive Assessment (MoCA), MoCa is a screening test used to detect mild cognitive decline and early signs of dementia. The total score of the test is 30 points.

The MoCA will be recored in scores., MoCA will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.|Body weight, We will used the bioelectrical impedance analysis (BIA), which is a method used for measuring body composition.Participants will be asked to step on to the BIA device, placing their feet on the foot electrodes.

The body weight will be recored in kilograms., Body weight will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.|Muscle mass, We will used the bioelectrical impedance analysis (BIA), which is a method used for measuring body composition.Participants will be asked to step on to the BIA device, placing their feet on the foot electrodes.

The muscle mass will be recored in kilograms., Muscle mass will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.|Body mass index (BMI), We will used the bioelectrical impedance analysis (BIA), which is a method used for measuring body composition.Participants will be asked to step on to the BIA device, placing their feet on the foot electrodes.

The BMI will be recored in kg/m\^2., BMI will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.|Percent body fat, We will used the bioelectrical impedance analysis (BIA), which is a method used for measuring body composition.Participants will be asked to step on to the BIA device, placing their feet on the foot electrodes.

Percent body fat will be recored in percentage., Percent body fat will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.|The duration during Timed Up and Go Test, The Timed Up and Go Test (TUG) is a test for assessing fall risk. Participants will begin by sitting on a chair. They will be asked to stand up, walk 3 meters away at a comfortable speed, turn around a traffic cone, walk back, and sit down.

TUG will be recored in second., TUG will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.|The repetition of Chair Stand Test, Chair Stand Test is used to test leg strength and endurance. Participants will begin by sitting on a chair. Participants will be instructed to stand up with full leg extension as quickly as possible, sit back down as quickly as possible, andrepeat this process for 30 seconds.

Chair Stand Test will be recorded in repetition., Chair Stand Test will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.|Muscle evoke potential (MEP), Participants will be stimulated at the primary motor cortex by transcranial magnetic stimulation to measure cortical excitability, which sends the motor outputs to Tibialis Anterior (TA) and Abductor Pollicis Brevis (APB) muscles. The MEP will be used to assess muscle activity in these muscles during the stimulation.

The MEP will be measured in mV., Muscle evoke potential will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.|Cortical silent period (CSP), Participants will be stimulated at the primary motor cortex by transcranial magnetic stimulation to measure cortical excitability, which sends the motor outputs to Tibialis Anterior (TA) and Abductor Pollicis Brevis (APB) muscles. The CSP will be used to assess muscle activity in these muscles during the stimulation.

The CSP will be measured in ms., Muscle evoke potential will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.|Cold temperature threshold, Participants will be stimulated by Quantitative Sensory Testing (QST) with cold temperature on their legs. QST is the standard device validated by the manufacturer and approved for use in research assessments, as demonstrated in the supplementary files.

Cold temperature threshold will be measure in degree Celsius., Cold temperature threshold will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.|Vibration threshold, Participants will be stimulated by Quantitative Sensory Testing (QST) with vibration threshold on their legs. QST is the standard device validated by the manufacturer and approved for use in research assessments, as demonstrated in the supplementary files.

Vibration threshold will be measure in μm., Vibration temperature threshold will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.