Dual-task Augmented Reality for PD DBS

Parkinson's Disease Clinical Trial

— DART for DBS  

Official title:

Dual-task Augmented Reality Treatment (DART) for Parkinson's Disease and Deep Brain Stimulation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06418152
• Other study ID #: 24-282
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 1, 2024
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2024
• Source: The Cleveland Clinic
• Contact: Elizabeth Jansen, MPH
• Phone: 216-780-9160
• Email: jansena[@]ccf.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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 user's 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult with a diagnosis of idiopathic PD

• History of deep brain stimulator placement for treatment of PD

• Ability to ambulate > 10 minutes continuously without an assistive device

Exclusion Criteria:

• Medical diagnosis of dementia or any neurocognitive impairment that compromises the ability to provide informed consent

->2 errors on the Short Portable Mental Status Questionnaire

• Musculoskeletal or cardiopulmonary issue that limits one's ability to engage in exercise

• Neurological disease other than Parkinson's disease that impacts motor or cognitive function

Related Conditions & MeSH terms

• Deep Brain Stimulation
• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Multi-modal treatment
Multi-modal treatment was designed to target PD-specific declines in the areas of cognitive function and gait and posture impairments. MMT consists of simultaneously training a motor and cognitive task.

Locations

Country	Name	City	State
United States	Cleveland Clinic Foundation	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Jay Alberts

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MDS-UPDRS III	Clinical assessment of PD motor symptoms	Baseline and through study completion, average 8 weeks
Secondary	Two Minute Walk Test	Distance traveled during a 2 minute period under single-and dual-task conditions	Baseline and through study completion, average 8 weeks