Ignite Creation Date:
2024-05-06 @ 8:28 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06393439
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-03-28
Brief Title:
Virtual Reality in Functional Movement Disorder
Sponsor:
Medical University of Graz
Organization:
Medical University of Graz
Study Overview
Official Title:
The Effect of Virtual Hand Movements on Functional Tremor - a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VR-FMD
Brief Summary:
This study investigates the effect of virtual reality VR motor tasks on functional movement disorders
Detailed Description:
The investigators want to investigate how different display modes of virtual hands and the experimental manipulation of the visual representation of virtual hand movements affect 1 the performance of the hand movements 2 the tremor and 3 the subjective perception of the tremor
There are three groups Patients with functional tremor FT patients with essential tremor ET and healthy controls HC The study is carried out on one or two consecutive days The first appointment is only made for patients with ET and FT and is used for the neurological examination and to assess the severity of the tremor It takes place at the Outpatient Clinic for Movement Disorders at the University Clinic for Neurology in Graz and lasts a maximum of 30 minutes The second appointment is at the Institute of Psychology at the University of Graz and requires the active participation of the respondent for 25 hours Subjects are asked not to take any tremor-influencing medication on the day of the examination HC will only attend the appointment at the Institute of Psychology
First appointment
Clinical Global Impression - Severity Scale CGI-S 5-point Likert scale clinicians assess the severity of the condition
Patient Global Impression of Severity PGI-S 5-point Likert scale patients assess the severity of the condition
Fahn Tolosa Marin Tremor Rating Scale FTM assesses the tremor severity
Simplified Version of the Functional Movement Disorders Rating Scale S-FMDRS assesses the severity of the functional tremor
Second appointment
1 Questionnaires
Simulator Sickness Questionnaire SSQ 4-point Likert scale assesses nausea oculomotor and visual disturbances disorientation 2 timepoints before and after VR tasks
Edinburgh Handedness Inventory EDI
Questionnaire about sociodemographic data
Technology Usage Inventory TUI 7-point Likert scale acceptance and use of technologies
Igroup Presence Questionnaire IPQ sense of presence in the VR
2 electroencephalogram EEG and surface-Electromyography surface-EMG of forearm muscles run synchronously with the examinations
3 VR-tasks all tasks are carried out in randomized order
1 3x3 matrix individual fields light up in random order participants are instructed to touch the fields in the given sequence as quickly as possible 30 repetitions with a realistic VR-hand model and 30 repetitions with an abstract VR-hand model
2 3x3 matrix same task as a but after each repetition participants must touch a field labeled next to continue the task 30 repetitions
3 apple in a box a virtual apple is to be placed in a virtual box using the hand with the weaker tremor while the other hand is left resting on the table 30 repetitions
4 apple in a box same task as c but the resting hand is not visible 30 repetitions
There are three groups Patients with functional tremor FT patients with essential tremor ET and healthy controls HC The study is carried out on one or two consecutive days The first appointment is only made for patients with ET and FT and is used for the neurological examination and to assess the severity of the tremor It takes place at the Outpatient Clinic for Movement Disorders at the University Clinic for Neurology in Graz and lasts a maximum of 30 minutes The second appointment is at the Institute of Psychology at the University of Graz and requires the active participation of the respondent for 25 hours Subjects are asked not to take any tremor-influencing medication on the day of the examination HC will only attend the appointment at the Institute of Psychology
First appointment
Clinical Global Impression - Severity Scale CGI-S 5-point Likert scale clinicians assess the severity of the condition
Patient Global Impression of Severity PGI-S 5-point Likert scale patients assess the severity of the condition
Fahn Tolosa Marin Tremor Rating Scale FTM assesses the tremor severity
Simplified Version of the Functional Movement Disorders Rating Scale S-FMDRS assesses the severity of the functional tremor
Second appointment
1 Questionnaires
Simulator Sickness Questionnaire SSQ 4-point Likert scale assesses nausea oculomotor and visual disturbances disorientation 2 timepoints before and after VR tasks
Edinburgh Handedness Inventory EDI
Questionnaire about sociodemographic data
Technology Usage Inventory TUI 7-point Likert scale acceptance and use of technologies
Igroup Presence Questionnaire IPQ sense of presence in the VR
2 electroencephalogram EEG and surface-Electromyography surface-EMG of forearm muscles run synchronously with the examinations
3 VR-tasks all tasks are carried out in randomized order
1 3x3 matrix individual fields light up in random order participants are instructed to touch the fields in the given sequence as quickly as possible 30 repetitions with a realistic VR-hand model and 30 repetitions with an abstract VR-hand model
2 3x3 matrix same task as a but after each repetition participants must touch a field labeled next to continue the task 30 repetitions
3 apple in a box a virtual apple is to be placed in a virtual box using the hand with the weaker tremor while the other hand is left resting on the table 30 repetitions
4 apple in a box same task as c but the resting hand is not visible 30 repetitions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None