Dual-task Augmented Reality Treatment (DART) for Parkinson's Disease and Deep Brain Stimulation
Phase: NA
Conditions: Parkinson's Disease, Deep Brain Stimulation
Sponsor: Jay Alberts

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TITLE: Dual-task Augmented Reality Treatment (DART) for individuals with Parkinson’s disease 
and deep brain stimulation  
 
Study #: NCT06418152 
 
Document Date: November 4, 2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PI: Jay Alberts, PhD 
DATE MODIFIED:  11/4/2024, Version 2 
 
Project Goal: 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).   
 
Rationale: Postural instability is a cardinal motor symptom of Parkinson’s disease (PD), and is 
often accompanied with non-motor symptoms such as cognitive impairment.1 Activities of daily 
living (ADL) frequently involve the simultaneous performance of two or more tasks, such as 
crossing the street while holding a conversation. The cognitive demands of dual-tasking to 
perform routine daily activities may lead to increased fall rates relative to healthy peers.2 
 
Multi-Modal Training in PD patients:  In order to treat dual-task impairment (difficulty 
performing two tasks at once), multi-modal treatment (MMT)3 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. We previously developed 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. We 
plan to expand the impact of that project through the investigation of DART in individuals with PD 
who have previously undergone DBS surgery. 
 
 
 

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APPROACH: We will conduct a preliminary study with up to 5 participants to determine the safety 
and preliminary efficacy of the DART platform on individuals with PD and DBS. It is hypothesized 
that the DART platform will result in few adverse events and will be well-tolerated by individuals 
with PD and DBS.  
 
Inclusion criteria: 
1) Adult with a diagnosis of idiopathic PD 
2) History of deep brain stimulator placement for treatment of 
PD 
 
Exclusion criteria:  
1) Medical diagnosis of dementia or any neurocognitive 
impairment that compromises the ability to provide 
informed consent.  
2) >2 errors on the Short Portable Mental Status 
Questionnaire4  
3) Musculoskeletal or cardiopulmonary issue that limits one’s 
ability to engage in exercise 
4) Neurological disease other than Parkinson’s disease that 
impacts motor or cognitive function 
   
DART Platform and Intervention: Up to five 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.  
 
Data Collection: Assessments of motor and non-motor function will be completed for all 
participants at the following time points: enrollment, midpoint, and end of treatment. Motor and 
non-motor outcomes are provided in Table 1. Assessments will be conducted in the “on-
medication” state (PD medication ~1 hour prior to testing) and with the DBS set to their clinical 
settings. Research personnel will inquire with the patient during a scheduling telephone call, the 
timing of their PD medications. All appointments will be scheduled approximately 1 hour after 
dosage so as to not disrupt the participants standard medication schedule. The outcomes 
assessor (Dr. Anson Rosenfeldt, DPT) will not have access to training performance data; the 
physical therapist (Dr. Ryan Kaya, DPT) performing the training will not be privy to the outcome 
assessments. Medication reconciliation will be completed at each assessment and levodopa 
equivalent daily doses (LEDDs) will be determined. Demographic and outcomes variables will be 
recorded in RedCap. Training and some motor outcome variables will be collected on the 
HoloLens2. Only a subject ID will be associated with the HoloLens 2 and no PHI is stored on the 
device. Optional photo/videos will be recorded on willing participants with Dr. Kaya utilizing his 
CCF phone. Immediately after the appointment, any photo/videos will be uploaded and stored on 
a Cleveland Clinic computer behind CCF firewalls. 
 
 
Figure 1:  Study flow diagram. 

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Power and Statistical Analysis:  The sample size (N=5) is reflective of the preliminary nature of 
the study. A repeated measured ANOVA will be used to compare the group at the three different 
time points (baseline, midpoint, and end of treatment).   
 
 
References: 
1. 
Jankovic J. Parkinson's disease: clinical features and diagnosis. J Neurol Neurosurg 
Psychiatry. Apr 2008;79(4):368-76. doi:10.1136/jnnp.2007.131045 
2. 
Heinzel S, Maechtel M, Hasmann SE, et al. Motor dual-tasking deficits predict falls in 
Parkinson's disease: A prospective study. Parkinsonism Relat Disord. May 2016;26:73-7. 
doi:10.1016/j.parkreldis.2016.03.007 
3. 
Rosenfeldt AB, Penko AL, Streicher MC, Zimmerman NM, Koop MM, Alberts JL. 
Improvements in temporal and postural aspects of gait vary following single- and multi-modal 
training in individuals with Parkinson's disease. Parkinsonism Relat Disord. May 14 
2019;doi:10.1016/j.parkreldis.2019.05.021 
4. 
Pfeiffer E. Short Portable Mental Status Questionnaire for Assessment of Organic Brain 
Deficit in Elderly Patients. Journal of the American Geriatrics Society. 1975;23(10):433-441. 
doi:DOI 10.1111/j.1532-5415.1975.tb00927.x 
 
Table 1: Outcome Metrics 
Assessment 
Description 
Primary Outcome 
Adverse events 
Such as falls, dizziness, and 
others as a result of the 
intervention 
Number of serious and non-
serious adverse events 
related to the intervention 
Two Minute Walk Test 
Distance traveled during a 2-
minute period under single- and 
dual-task conditions 
Distance (meters) 
MDS-UPDRS III 
Clinical assessment of PD motor 
symptoms 
Total score 
Timed Up and Go Test (TUG) 
Stand from chair, walk 3 meters, 
turn, return to chair under single- 
and dual-task conditions 
Duration (seconds) 
Postural sway  
Amount of sway in multiple 
directions 
Sway distance (cm) 
Cognitive performance  
During single- and dual-task 
conditions 
Number of correct 
responses 
System Usability Scale and other 
usability/satisfaction surveys 
Usability of HoloLens and DART 
protocol technology  
Total score 
Activities-specific balance 
confidence scale (ABC) 
Balance confidence during daily 
tasks 
Total score 
Fall Diary 
To track fall events 
Number of falls