Parkinson's DiseaseDART for DBSNCT06418152
Dual-task Augmented Reality for PD DBS
A study testing Multi-modal treatment in people with Parkinson's Disease and Deep Brain Stimulation, run by Jay Alberts at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease, Deep Brain Stimulation
- What is being tested?
- Multi-modal treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 21 May 2024to 30 Jan 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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.
- Conditions
- Parkinson's Disease, Deep Brain Stimulation
- Being tested
- Multi-modal treatment
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-modal treatmentBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interventional Arm | Experimental | 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 Receives: Behavioral: Multi-modal treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and through study completion, average 8 weeks
Secondary outcomes (1)
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.
Measured: Baseline and through study completion, average 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start21 May 2024
- Primary completion30 Jan 2025
- Study completion30 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 5 to 10 individuals with previously implanted deep brain stimulation and Parkinson's disease
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jay Alberts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jay Alberts, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06418152
- Sponsor's protocol ID
- 24-282
- Acronym
- DART for DBS
- Status last verified
- Sep 2025
- First submitted
- 9 May 2024
- Last updated
- 30 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-task Augmented Reality Treatment (DART) for Parkinson's Disease and Deep Brain Stimulation
- ClinicalTrials.gov ID
- NCT06418152
- Acronym / sponsor ID
- DART for DBS / 24-282
- Conditions
- Parkinson's Disease, Deep Brain Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Jay AlbertsUniversity, hospital or other
- Study start
- 21 May 2024 (actual)
- Primary completion
- 30 Jan 2025 (actual)
- Study completion
- 30 Jan 2025 (actual)
- First posted
- 17 May 2024 (actual)
- Results
- Posted 30 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 5 to 10 individuals with previously implanted deep brain stimulation and Parkinson's disease
| Arm | Type | Receives |
|---|---|---|
| Interventional Arm | Experimental | Behavioral: Multi-modal treatmentFive 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-modal treatmentMulti-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. | Behavioural | Interventional Arm |
Primary outcome
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score
Time frame: Baseline and through study completion, average 8 weeks
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.
1 secondary outcome
Two Minute Walk Test
Time frame: Baseline and through study completion, average 8 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Parkinson's Disease
Recruiting
Decoding the Neural Mechanisms Underlying Postural Instability and Gait Dysfunction in Parkinson's Disease
Parkinson Disease, Freezing of Gait
Enrolling by invitationPhase 1/2
Lithium for Parkinson's: an Extension Trial
Parkinson Disease
Recruiting
Genetics and Aerobic Exercise to Slow Parkinson's Disease Trial
Parkinson Disease
Recruiting
Deep Brain Stimulation Surgery for Movement Disorders
Parkinson's Disease, Essential Tremor
Active, not recruitingPhase 1/2
Repurposing Lithium for Parkinson's Disease: a RCT
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-modal treatment in people with Parkinson's Disease and Deep Brain Stimulation, run by Jay Alberts at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Movement Disorder Society Unified Parkinson's Disease Rating Scale Part III: Motor Examination Score (time frame: Baseline and through study completion, average 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025.