Dual-task Augmented Reality for PD DBS

NCT06418152 | Completed Results

• 1 other identifier: 24-282
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Parkinson's Disease; Deep Brain Stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Two Minute Walk Test

  Baseline and through study completion, average 8 weeks

Study Arms (1)

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

Behavioral: Multi-modal treatment

Interventions

Multi-modal treatment BEHAVIORAL

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.

Interventional Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jay Alberts: lead

Study Sites (1)

Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Jay Alberts, PhD
• Organization: Cleveland Clinic

albertj@ccf.org

216-445-3222

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Center Director

Model Details: 5 to 10 individuals with previously implanted deep brain stimulation and Parkinson's disease

Study Record Dates

• First Submitted: May 9, 2024
• First Posted: May 17, 2024
• Study Start: May 21, 2024
• Primary Completion: January 30, 2025
• Study Completion: January 30, 2025
• Last Updated: September 30, 2025
• Results First Posted: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)