Assessing Fall Risk Using Transcranial Magnetic Stimulation and Quantitative Sensory Testing

NCT06480279 | Completed DMC

• 1 other identifier: COA No. 0607/2024
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Fall

Keywords

Transcranial Magnetic Stimulation; Quantitative Sensory Testing; Falls; Elderly

Outcome Measures

Primary Outcomes (11)

• 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.

Study Arms (4)

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.

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Thai elderly who have received check-ups or treatment at King Chulalongkorn Memorial Hospital, Bangkok, Thailand.

You may qualify if:

• \) Male and female individuals aged 65-80 years.

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead
• King Chulalongkorn Memorial Hospital: collaborator
• National Research Council of Thailand: collaborator

Study Sites (1)

Department of Medicine, Faculty of Medicine, Chulalongkorn University.

Bangkok, 10330, Thailand

Location

Study Officials

• Jakkrit Amornvit, MD

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

• Phunsuk Kantha, PT.,PhD

  Mahidol University

  PRINCIPAL INVESTIGATOR

• Kulvara Lapanan, PT

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2024
• First Posted: June 28, 2024
• Study Start: May 16, 2024
• Primary Completion: May 16, 2025
• Study Completion: August 16, 2025
• Last Updated: September 25, 2025

Record last verified: 2024-06

Locations

TH (1)