The primary objective of this clinical study is to provide the initial validation for monitoring biomarkers of symptoms and functioning for individuals with FTLD syndromes.
Researchers at BioSensics and Johns Hopkins School of Medicine will use wearable sensors, computerized speech, psychomotor, and cognitive assessments to create outcome measures and digital biomarkers for FTLD syndromes. Researchers will deploy this digital health solution to monitor 20 patients with FTLD syndromes for 12 months with study visits every 3 months.
Male and female participants aged 40 years or older with a clinical diagnosis of possible or probable FTLD syndrome phenotype.
Participants must be fluent in reading and speaking English and must be capable of providing informed consent based on the principal investigator's judgment.
Individuals eligible for inclusion must be able to comply with the protocol per the investigator's judgment and must have a caregiver or study partner who is willing and able to assist with all study-related procedures.
Any neurological, medical, or psychiatric condition that would preclude or confound participation in study activities based on the investigator's judgment.
Individuals who have a history of frequent falls defined as more than 5 falls per month.
The study intends to enroll a diverse population of individuals representative of the general FTLD syndrome population. There are no restrictions based on race or ethnic origin. This study will enroll both male and female participants aged 40 years or older with a clinical diagnosis of possible or probable FTLD syndrome phenotype.
Cohort
Prospective
Not listed
Physical Activity Monitoring
Following each clinical visit, participants will be asked to wear a PAMSys pendant sensor and two PAMSys ULM wrist sensors for 14 days at home. The average daily number of steps will be measured using the PAMSys pendant.
Hand Function Monitoring
Following each clinical visit, participants will be asked to wear two PAMSys ULM wrist sensors for 14 days at home. Average daily number of hand goal-directed movements will be measured using the PAMSys ULM wrist sensors.
Zarit Burden Interview (ZBI)
The ZBI is completed by a reliable caregiver. The ZBI scores range from 0-88, where 88 represents a worse outcome.
Montreal Cognitive Assessment (MoCA)
This is a brief global cognitive screening assessment. Scores range from 0 to 30 where 0 represents a worse outcome.
Cortical Basal Ganglia Functional Scale (CBFS)
The CBFS is a rating scale that evaluates experiences in daily living (EDL's) and consists of 14 questions on Motor EDL's and 17 questions on Non-Motor EDL's, each of which are rated on a Likert 5 point scale rating function from 0 to 4, where 0 = Normal or No problems and 4 = Severe problems. The questions are for the patient, but should be answered by both the patient and their caregiver together.
Progressive Supranuclear Palsy Rating Scale (PSPRS)
The PSP Rating Scale (PSPRS) is a 28-item clinical assessment used to measure the severity and progression of Progressive Supranuclear Palsy (PSP). Out of the 28-items, 6 are scored on a 3 point scale (0-3) and 22 are scored on a 4 point scale (0-4). The PSPRS ranges from a score of 0-100 with a higher number representing a greater impairment from the disease.
Digital Speech Assessment
Using a study tablet, participants will perform a series of digital speech assessments. The collected speech data will be analyzed using BioDigit Speech, an automatic speech analysis software developed by BioSensics.
Digital Cognitive Assessment
Using a study tablet, participants will perform a series of digital cognitive assessments.
Digital Fine Motor Control Assessment
Using a study tablet, participants will perform a series of tapping tests.
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BioSensics
Lead sponsor
Johns Hopkins University
Collaborator
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