Dual-task Augmented Reality for PD DBS (DART for DBS)

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

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).

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease; Deep Brain Stimulation
• Intervention / Treatment: Behavioral: Multi-modal treatment

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 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.

• Study Type: Interventional
• Enrollment (Actual): 7
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Interventional Arm; Five to ten individuals with PD and DBS will receive the DART intervention. The 16 DART sessions will be delivered over an 8-week period (but not more than 10-weeks). Each DART session will consist of approximately 30-minutes of dual-task activity and will be scheduled over a 1 hour period. A physical therapist or physical therapist assistant will oversee each session. Exercises will be progressed based on results from the DART platform, feedback from the participant, and the clinical expertise of the physical therapist or physical therapist assistant

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score	Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination score, measured off medication. Range of scores is 0 to 132, with lower score indicating better motor function. Change in MDS-UPDRS III score from baseline through completion.	Baseline and through study completion, average 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Two Minute Walk Test	Distance traveled during a 2 minute period under single-and dual-task conditions. Number reported is the change in distance from baseline to end of intervention.	Baseline and through study completion, average 8 weeks

Collaborators and Investigators

• Sponsor: Jay Alberts

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2024
• Primary Completion (Actual): January 30, 2025
• Study Completion (Actual): January 30, 2025

Study Registration Dates

• First Submitted: May 9, 2024
• First Submitted That Met QC Criteria: May 15, 2024
• First Posted (Actual): May 17, 2024

Study Record Updates

• Last Update Posted (Estimated): September 30, 2025
• Last Update Submitted That Met QC Criteria: September 10, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Synucleinopathies; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Parkinson Disease
• Other Study ID Numbers: 24-282

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No