Clinical trial NCT06480279: Assessing Fall Risk Using Transcranial Magnetic Stimulation and Quantitative Sensory Testing
Official title: Development of Artificial Intelligence Innovation for Assessing Fall Risk Using Clinical Neurological Studies With Transcranial Magnetic Stimulation and Quantitative Sensory Testing in the Thai Elderly
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Fall
Keywords: Transcranial Magnetic Stimulation
Quantitative Sensory Testing
Falls
Elderly
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2024-06-28
Enrollment: 150
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Thai elderly who have received check-ups or treatment at King Chulalongkorn Memorial Hospital, Bangkok, Thailand.

Brief 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.

Detailed description: The data collection will be arranged in the same order. Practice trials will be provided before the start of the data collection. The entire data collection session will take approximately 90 minutes. Data collection will be conducted for both the baseline and the 3-month follow-up.

The data collection will include:

1. Demographic information such as age, sex, body height, body weight, body mass index, medical history, medical diagnosis, body composition, and the MoCA (Montreal Cognitive Assessment).
2. Neurophysiological assessments such as electromyography and Quantitative Sensory Testing (QST).
3. Functional tests such as the Timed up and go test and Chait stand test.

Eligibility criteria: Inclusion Criteria:

1) Male and female individuals aged 65-80 years.

Exclusion Criteria:

1. History of previous lower limb surgery, such as total knee replacement or ankle surgery.
2. History of a neurological disorder, such as stroke or Parkinson's disease.
3. History of vestibular disease, such as Meniere's disease.
4. History of seizures or epilepsy.
5. The presence of metal implanted devices in or around the head area
6. MoCA score \< 26

Primary outcomes:
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: MoCA will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
measure: Body weight
timeFrame: Body weight will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
measure: Muscle mass
timeFrame: Muscle mass will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
measure: Body mass index (BMI)
timeFrame: BMI will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
measure: Percent body fat
timeFrame: Percent body fat will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
measure: The duration during Timed Up and Go Test
timeFrame: TUG will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
measure: The repetition of Chair Stand Test
timeFrame: Chair Stand Test will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
measure: Muscle evoke potential (MEP)
timeFrame: Muscle evoke potential will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
measure: Cortical silent period (CSP)
timeFrame: Muscle evoke potential will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
measure: Cold temperature threshold
timeFrame: Cold temperature threshold will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
measure: Vibration threshold
timeFrame: Vibration temperature threshold will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Medicine, Faculty of Medicine, Chulalongkorn University.
Study officials:
affiliation: Chulalongkorn University
name: Jakkrit Amornvit, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mahidol University
name: Phunsuk Kantha, PT.,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Chulalongkorn University
name: Kulvara Lapanan, PT
role: PRINCIPAL_INVESTIGATOR
References: