Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418152
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-09
Brief Title:
Dual-task Augmented Reality for PD DBS
Sponsor:
Jay Alberts
Organization:
The Cleveland Clinic
Study Overview
Official Title:
Dual-task Augmented Reality Treatment DART for Parkinsons Disease and Deep Brain Stimulation
Status:
RECRUITING
Status Verified Date:
2024-05
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:
DART for DBS
Brief Summary:
The goal of this project is to evaluate the safety and preliminary effectiveness of utilizing a digital therapeutic Dual-task Augmented Reality Treatment DART protocol for the treatment of postural instability and gait dysfunction PIGD in individuals with PD with a previously implanted deep brain stimulator DBS
Detailed Description:
Multi-Modal Training in PD patients In order to treat dual-task impairment difficulty performing two tasks at once multi-modal treatment MMT was designed to target PD-specific declines in the areas of cognitive function and gait and posture impairments Briefly MMT training consists of simultaneously training a motor and cognitive task The motor aspect of MMT stresses high velocity high amplitude training principles while the cognitive aspect stresses commonly impaired cognitive domains in PD such as attention and executive function An example of an MMT task is marching while spelling words backwards
Delivery of a Digital Therapeutic via Augmented Reality for the Treatment of PIGD The MMT intervention is well-suited for integration into an augmented reality AR platform as it consists of the patient performing a series of cognitive and motor tasks simultaneously while the patient receives knowledge of performance and results from a therapist The Microsoft HoloLens is an untethered AR headset used in applications as broad as teaching anatomy displaying fine art and gaming With AR the user maintains contact with the physical world and the people in it The HoloLens uses AR technology to place holograms objects made entirely of projected light into the users physical environment hence creating a first-person mixed reality environment These holograms can be viewed from different angles and distances can be two-dimensional or three-dimensional can appear life-like can move be shaped and change according to interaction with users or the physical environment in which they are projected depending on the programming The MMT was previously developed for the Dual-task Augmented Reality Treatment DART which delivers MMT training on a head-mounted AR display The DART platform was successfully piloted in 50 individuals with PD who did not have DBS IRB 20-207 The results of the project indicate that DART is an effective method of training for individuals with PD The goal is to expand the impact of that project through the investigation of DART in individuals with PD who have previously undergone DBS surgery
Delivery of a Digital Therapeutic via Augmented Reality for the Treatment of PIGD The MMT intervention is well-suited for integration into an augmented reality AR platform as it consists of the patient performing a series of cognitive and motor tasks simultaneously while the patient receives knowledge of performance and results from a therapist The Microsoft HoloLens is an untethered AR headset used in applications as broad as teaching anatomy displaying fine art and gaming With AR the user maintains contact with the physical world and the people in it The HoloLens uses AR technology to place holograms objects made entirely of projected light into the users physical environment hence creating a first-person mixed reality environment These holograms can be viewed from different angles and distances can be two-dimensional or three-dimensional can appear life-like can move be shaped and change according to interaction with users or the physical environment in which they are projected depending on the programming The MMT was previously developed for the Dual-task Augmented Reality Treatment DART which delivers MMT training on a head-mounted AR display The DART platform was successfully piloted in 50 individuals with PD who did not have DBS IRB 20-207 The results of the project indicate that DART is an effective method of training for individuals with PD The goal is to expand the impact of that project through the investigation of DART in individuals with PD who have previously undergone DBS surgery
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