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Behavioral Intervention

Augmented Reality for Parkinson's Disease (DART for DBS Trial)

Phase < 1
Recruiting
Research Sponsored by Jay Alberts
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ability to ambulate > 10 minutes continuously without an assistive device
Adult with a diagnosis of idiopathic PD
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and through study completion, average 8 weeks
Awards & highlights

Summary

This trial aims to test if a new digital therapy called Dual-task Augmented Reality Treatment (DART) can help improve balance and walking difficulties in people with Parkinson's disease who already have a deep brain

Who is the study for?
This trial is for individuals with Parkinson's Disease who already have a deep brain stimulator implanted. It aims to help those struggling with balance and walking issues. Specific eligibility details are not provided, but typically participants must meet certain health standards and not have conditions that could interfere with the study.
What is being tested?
The trial is testing a digital therapy called Dual-task Augmented Reality Treatment (DART). This new approach combines cognitive tasks and physical movements to improve stability and gait in Parkinson's patients using their existing DBS devices.
What are the potential side effects?
Since DART is non-invasive, side effects may be minimal compared to drug treatments. However, they might include discomfort from wearing AR equipment or fatigue from performing tasks. The exact side effects will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk for more than 10 minutes without help.
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I have been diagnosed with Parkinson's disease.
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I have a deep brain stimulator for Parkinson's disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a heart or muscle condition that limits my ability to exercise.
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I have a neurological condition affecting my movement or thinking, but it's not Parkinson's.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and through study completion, average 8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline and through study completion, average 8 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
MDS-UPDRS III
Secondary outcome measures
Two Minute Walk Test

Trial Design

1Treatment groups
Experimental Treatment
Group I: Interventional ArmExperimental Treatment1 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

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Who is running the clinical trial?

Jay AlbertsLead Sponsor
2 Previous Clinical Trials
215 Total Patients Enrolled
~2 spots leftby Dec 2024
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