Engineering Clinical Studies at University of Trieste

Universit degli Studi di Trieste Corso di Laurea Magistrale in INGEGNERIA CLINICA UNIFIED MODELING LANGAUGE BASICS Corso di Informatica Medica Docente Sara Renata Francesca MARCEGLIA Universit degli Studi di Trieste Dipartimento di Ingegneria e Architettura

Universit degli Studi di Trieste SCENARIO

Universit degli Studi di Trieste SCENARIO Si vuole studiare la aDBS mediante un prototipo esterno in pazienti che stanno cambiando lo stimolatore a causa dell esaurimento della batteria

Universit degli Studi di Trieste 4 SCENARIO PROTOCOLLO SPERIMENTALE

Universit degli Studi di Trieste SCENARIO SHORT-TERM FOLLOW UP

Universit degli Studi di Trieste SCENARIO Day 9 and Day 10: B. Monitoring of motor symptoms fluctuations The patient will wear a bracelet equipped with a three-axial accelerometer and will fill in his/her Patient s Diary every 90 minutes (night excluded) and the DBS-IS (daily). Day 10: Discharge At Day 10, at the end of the experimental session (late in the morning), if symptoms will be well controlled by the combined effect of DBS and dopaminergic therapy, if the patient can tolerate an interruption of DBS stimulation for 24 hours and if the neurologist will deem the patient suitable to continue the trial the patient will be discharged. Days 4 to 9 and Days 11 to 16: Remote monitoring The patient will wear a bracelet equipped with a three-axial accelerometer, possibly all day long, and will fill in his/her Patient s Diary, every 90 minutes (night excluded) and the DBS-IS (daily) .

Universit degli Studi di Trieste SCENARIO Day 17: Clinical assessment and second surgery At Day 17, after 2 weeks of follow-up, the patient will be re-hospitalized in the morning and will undergo a clinical assessment will be hospitalized in the morning and will undergo a clinical assessment including UPDRS III, UDysRS, DBS-IS and examining for possible side effects, in stim-ON/med- OFF condition, and including automatic collection of the parameters needed to calculate the TEED from the AlphaDBS device. On the same day or on Day 18, patient will undergo the second surgery, according to medical advice. During the second surgery, in local anesthesia, the surgeon will place the new IPG, as foreseen in normal practice (Incision A, Fig. 2B). The same surgery will be performed on any patient discontinuing the study at any time.

Universit degli Studi di Trieste SCENARIO Activity Time Place Patient Neurologist/Bioingineer Start End DBS OFF Bracelet on Consultation room Rests on a chair 7:30! 7:40 Rests on a chair, Free activities Setup Gait and Speech sensors Consultation room 7:40! 8:00 Physician s clinical assessments T0 (AE, UPDRS III, UDysRS) and video recording Rests on a chair, Free activities Fills Patient Diary Consultation room 8:00! 8:20 Consultation room or corridor 8:20! Walks 20 mt for up to 5 times Gait Analysis* 8:40 Performs tasks requested in speech analysis Consultation Room 8:40! Speech Analysis* 9:00 Bioengineer enters the randomization code for setting DBS mode- DBS ON Consultation room 9:10 9:00! Rests on a chair Rests on a chair, Free activities Fills Patient Diary Consultation room 9:10! _ 10:00 Physician s clinical assessments T1 (AE, UPDRS III, UDysRS) and video recording Rests on a chair, Free activities Fills Patient Diary Consultation room 10:00! 10:20 Consultation room or corridor 10:20! Walks 20 mt for 5 times Gait Analysis* 10:40 Perform tasks requested in speech analysis Consultation Room 10:40! Speech Analysis* 11:00 Consultation room 11:00! Receives Levodopa Levodopa challenge 11:00 Snack, rests on a chair /Free activities Fills Patient Diary Consultation room 11:00! UDysRS every 15 minutes 12:00 20 Physician s clinical assessments T2 (AE, UPDRS III, DBS-IS, UDysRS every Rests on a chair, Free activities Fills Patient Diary Consultation room 12:00! 20 12:20 20

Activity Time Place Patient Neurologist/Bioingineer Start End DBS OFF Bracelet on Consultation room Rests on a chair 7:30! 7:40 Rests on a chair, Free activities Setup Gait and Speech sensors Consultation room 7:40! 8:00 Physician s clinical assessments T0 (AE, UPDRS III, UDysRS) and video recording Rests on a chair, Free activities Fills Patient Diary Consultation room 8:00! 8:20 Universit degli Studi di Trieste Consultation room or corridor SCENARIO 8:20! Walks 20 mt for up to 5 times Gait Analysis* 8:40 Performs tasks requested in speech analysis Consultation Room 8:40! Speech Analysis* 9:00 Activity Time Bioengineer enters the randomization code for Consultation 9:10 Place room 9:00! Rests on a chair Patient Neurologist/Bioingineer setting DBS mode- DBS ON Start End DBS OFF Bracelet on Consultation room room Rests on a chair Rests on a chair, Free activities Fills Patient Diary Consultation 7:30! 9:10! 7:40 10:00 _ Rests on a chair, Free activities Rests on a chair, Free activities Fills Patient Diary Setup Gait and Speech sensors assessments T1 (AE, UPDRS III, UDysRS) and video recording Consultation room Consultation room Physician s clinical 7:40! 10:00! 8:00 10:20 Physician s clinical assessments T0 (AE, UPDRS III, UDysRS) and video recording Gait Analysis* Rests on a chair, Free activities Fills Patient Diary Walks 20 mt for 5 times Consultation room Consultation room or corridor 8:00! 10:20! 8:20 10:40 Consultation room or corridor Room 8:20! 10:40! Walks 20 mt for up to 5 times Perform tasks requested in speech analysis Consultation Gait Analysis* Speech Analysis* 8:40 11:00 Performs tasks requested in speech analysis Receives Levodopa Consultation Room room 8:40! 11:00! Speech Analysis* Levodopa challenge 9:00 11:00 Consultation Bioengineer enters the randomization code for setting DBS mode- DBS ON Consultation room room 9:10 9:00! 11:00! Rests on a chair Snack, rests on a chair /Free activities Fills Patient Diary Consultation UDysRS every 15 minutes 12:00 20 Rests on a chair, Free activities Fills Patient Diary Rests on a chair, Free activities Fills Patient Diary Consultation room Consultation room 9:10! 12:00! 20 12:20 20 _ 10:00 Physician s clinical assessments T2 (AE, UPDRS III, DBS-IS, UDysRS every Physician s clinical assessments T1 (AE, UPDRS III, UDysRS) and video recording Rests on a chair, Free activities Fills Patient Diary Consultation room 10:00! 10:20 Consultation room or corridor 10:20! Walks 20 mt for 5 times Gait Analysis* 10:40 Perform tasks requested in speech analysis Consultation Room 10:40! Speech Analysis* 11:00 Consultation room 11:00! Receives Levodopa Levodopa challenge 11:00 Snack, rests on a chair /Free activities Fills Patient Diary Consultation room 11:00! UDysRS every 15 minutes 12:00 20 Physician s clinical assessments T2 (AE, UPDRS III, DBS-IS, UDysRS every Rests on a chair, Free activities Fills Patient Diary Consultation room 12:00! 20 12:20 20

Universit degli Studi di Trieste SCENARIO Activity Time Place Patient Neurologist/Bioingineer Start End DBS OFF Consultation Rests on a chair Consultation room or corridor room 7:30! 12:40 7:40 12:20! Walks 20 mt for 5 times Gait Analysis* Bracelet on Rests on a chair, Free activities Setup Gait and Speech Consultation room Perform tasks requested in speech analysis Consultation Room 7:40! 13:00 8:00 12:40! Speech Analysis* sensors Physician s clinical assessments T0 (AE, UPDRS III, UDysRS) and video recording Lunch, Rests on a chair, Free activities Fills Patient Diary activities Fills Patient Diary Patient s Room Consultation room 13:00! 20 13:30 20 8:00! _ Rests on a chair, Free 8:20 Physician s clinical assessments T3 (AE, UPDRS III, UDysRS) and video recording Rests, Free activities Fills Patient Diary Walks 20 mt for up to 5 times 13:30! 20 13.50 20 8:20! Patient s Room Consultation room or corridor Gait Analysis* 8:40 Performs tasks requested in speech analysis Consultation 8:40! Speech Analysis* 9:00 Rests on a chair, Free activities Fills Patient Diary Patient s Room Room 13:50! 20 15:00 20 _ Bioengineer enters the randomization code for setting DBS mode- DBS ON Consultation room 9:10 Physician s clinical assessments T4 (AE, UPDRS III, UDysRS) and video recording _ 9:00! Rests on a chair Rests on a chair, Free activities Fills Patient Diary 15:00! 20 15:20 20 Patient s Room Rests on a chair, Free activities Fills Patient Diary Consultation room 9:10! 10:00 Snack, Rests, Free activities, Fills Patient Diary Rests on a chair, Free activities Fills Patient Diary 15:20! 20 16:30 20 _ Patient s Room Physician s clinical assessments T1 (AE, UPDRS III, UDysRS) and video recording ? Consultation room 10:00! 10:20 Consultation room or corridor 10:20! Walks 20 mt for 5 times Gait Analysis* 10:40 Perform tasks requested in speech analysis Consultation Room 10:40! Speech Analysis* 11:00 Consultation room 11:00! Receives Levodopa Levodopa challenge 11:00 Snack, rests on a chair /Free activities Fills Patient Diary Consultation room 11:00! UDysRS every 15 minutes 12:00 20 Physician s clinical assessments T2 (AE, UPDRS III, DBS-IS, UDysRS every Rests on a chair, Free activities Fills Patient Diary Consultation room 12:00! 20 12:20 20

Universit degli Studi di Trieste SCENARIO Activity Time Place Patient Neurologist/Bioingineer Start End DBS OFF Bracelet on Consultation room Physician s clinical assessments T5 (AE, UPDRS III, UDysRS) and video recording Setup Gait and Speech sensors Rests on a chair 7:30! 7:40 Rests, Free activities, Fills Patient Diary Rests on a chair, Free activities 16:30! 20 16:50 20 Patient s Room Consultation room 7:40! 8:00 Rests, Free activities, Fills Patient Diary Rests on a chair, Free activities Fills Patient Diary 16:50! 20 18:00 20 _ Patient s Room Physician s clinical assessments T0 (AE, UPDRS III, UDysRS) and video recording Consultation room 8:00! 8:20 Physician s clinical assessments T6 (AE, UPDRS III, UDysRS) and video recording Gait Analysis* Rests, Free activities Fills Patient Diary 18:00! 20 18:20 20 Patient s Room Consultation room or corridor 8:20! Walks 20 mt for up to 5 times 8:40 Dinner _ 19.30 8:40! Patient s Room Consultation Room Performs tasks requested in speech analysis Speech Analysis* 9:00 ? Bioengineer enters the randomization code for setting DBS mode- DBS ON Consultation room 9:10 9:00! Rests on a chair Rests on a chair, Free activities Fills Patient Diary Consultation room 9:10! _ 10:00 Physician s clinical assessments T1 (AE, UPDRS III, UDysRS) and video recording Rests on a chair, Free activities Fills Patient Diary Consultation room 10:00! 10:20 Consultation room or corridor 10:20! Walks 20 mt for 5 times Gait Analysis* 10:40 Perform tasks requested in speech analysis Consultation Room 10:40! Speech Analysis* 11:00 Consultation room 11:00! Receives Levodopa Levodopa challenge 11:00 Snack, rests on a chair /Free activities Fills Patient Diary Consultation room 11:00! UDysRS every 15 minutes 12:00 20 Physician s clinical assessments T2 (AE, UPDRS III, DBS-IS, UDysRS every Rests on a chair, Free activities Fills Patient Diary Consultation room 12:00! 20 12:20 20

Universit degli Studi di Trieste ATTORI ATTORI SOGGETTO ATTORI OGGETTO Dispositivo Neurologo (fa la valutazione blind) Bioingegnere Infermiere Paziente (compila il diario blind) Braccialetto Dizionari (farmaci, concetti clinici) Chirurgo Principal Investigator (PI) CRF Scale cliniche da compilare (domande) Scala clinica compilata (risposta) Patient diary Adverse Event report Farmaco assunto

Universit degli Studi di Trieste SHORT-TERM EVALUATION

Universit degli Studi di Trieste SHORT-TERM EVALUATION

Universit degli Studi di Trieste SHORT-TERM EVALUATION

Universit degli Studi di Trieste VALUTAZIONE CLINICA