FallNCT06480279
Assessing Fall Risk Using Transcranial Magnetic Stimulation and Quantitative Sensory Testing
An observational study of Fall, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 to 80 years
- Conditions the study is for
- Fall
- How many people
- 150 participants
- Where
- 1 siteThailand
- Study dates
- 16 May 2024to 16 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 to 80 years
- All sexes
- Older adult
Study population: Thai elderly who have received check-ups or treatment at King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
Who may be able to join
- 1) Male and female individuals aged 65-80 years.
Who cannot join
- History of previous lower limb surgery, such as total knee replacement or ankle surgery.
- History of a neurological disorder, such as stroke or Parkinson's disease.
- History of vestibular disease, such as Meniere's disease.
- History of seizures or epilepsy.
- The presence of metal implanted devices in or around the head area
- MoCA score < 26
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Medicine, Faculty of Medicine, Chulalongkorn University.
Bangkok, 10330
About this study
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
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.
Read the 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:
- 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).
- Neurophysiological assessments such as electromyography and Quantitative Sensory Testing (QST).
- Functional tests such as the Timed up and go test and Chait stand test.
- Conditions
- Fall
- Keywords
- Transcranial Magnetic Stimulation, Quantitative Sensory Testing, Falls, Elderly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Non-fallers | Elderly without history of fall | |
| Fallers-low risk | Elderly with a history of falling 1 time within the last year. | |
| Fallers-moderate risk | Elderly with a history of falling twice within the last year. | |
| Fallers-high risk | Elderly with a history of falling >2 times within the last year. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Vibration temperature threshold will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2024
- Study start16 May 2024
- Primary completion16 May 2025
- Study completion16 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- King Chulalongkorn Memorial Hospital, National Research Council of Thailand
- Responsible party
- Sponsor
- Investigators
- Jakkrit Amornvit, MD, Principal investigator, Chulalongkorn UniversityPhunsuk Kantha, PT.,PhD, Principal investigator, Mahidol UniversityKulvara Lapanan, PT, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06480279
- Sponsor's protocol ID
- COA No. 0607/2024
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2024
- Last updated
- 25 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06480279
- Acronym / sponsor ID
- COA No. 0607/2024
- Conditions
- Fall
- Keywords
- Transcranial Magnetic Stimulation, Quantitative Sensory Testing, Falls, Elderly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- King Chulalongkorn Memorial Hospital, National Research Council of Thailand
- Study start
- 16 May 2024 (actual)
- Primary completion
- 16 May 2025 (actual)
- Study completion
- 16 Aug 2025 (actual)
- First posted
- 28 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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).
- Neurophysiological assessments such as electromyography and Quantitative Sensory Testing (QST).
- Functional tests such as the Timed up and go test and Chait stand test.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Non-fallers | – | –Elderly without history of fall |
| Fallers-low risk | – | –Elderly with a history of falling 1 time within the last year. |
| Fallers-moderate risk | – | –Elderly with a history of falling twice within the last year. |
| Fallers-high risk | – | –Elderly with a history of falling >2 times within the last year. |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Age groups
- Older adult
- Study population
- Thai elderly who have received check-ups or treatment at King Chulalongkorn Memorial Hospital, Bangkok, Thailand.
Key inclusion criteria (1 listed)
- 1) Male and female individuals aged 65-80 years.
Key exclusion criteria (6 listed)
- History of previous lower limb surgery, such as total knee replacement or ankle surgery.
- History of a neurological disorder, such as stroke or Parkinson's disease.
- History of vestibular disease, such as Meniere's disease.
- History of seizures or epilepsy.
- The presence of metal implanted devices in or around the head area
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: MoCA will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
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.
Body weight
Time frame: Body weight will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
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.
Muscle mass
Time frame: Muscle mass will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
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.
Body mass index (BMI)
Time frame: BMI will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
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.
Percent body fat
Time frame: Percent body fat will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
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.
The duration during Timed Up and Go Test
Time frame: TUG will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
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.
The repetition of Chair Stand Test
Time frame: Chair Stand Test will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
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.
Muscle evoke potential (MEP)
Time frame: Muscle evoke potential will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
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.
Cortical silent period (CSP)
Time frame: Muscle evoke potential will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
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.
Cold temperature threshold
Time frame: Cold temperature threshold will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
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.
Vibration threshold
Time frame: Vibration temperature threshold will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jakkrit Amornvit, MD principal investigator
Chulalongkorn University
Phunsuk Kantha, PT.,PhD principal investigator
Mahidol University
Kulvara Lapanan, PT principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fall, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) (time frame: MoCA will be measured at two time points (baseline and 3 months), through study completion, an average of 1 year.). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2025.