MedTrace Logo

Remote Optimization, Adjustment and Measurement for Deep Brain Stimulation

NCT05269862 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2023-07-21

No results posted yet for this study

Summary

The purpose of the ROAM-DBS study is to compare the time needed to achieve a 1 point improvement Patient's Global Impression of change (PGIC) relative to the subject's status at the end of the ADROIT initial programming visit in subjects who receive programming updates via in-clinic sessions and subjects who additionally have the option of receiving programming updates via Virtual Clinic sessions. The study intends to demonstrate shorter times to achieve benefit in the Virtual Clinic cohort.

Conditions

  • Parkinson Disease

Interventions

DEVICE

Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature

Implant and initial programming of the Infinity DBS system for this cohort are conducted according to the sites standard of care. After initial programming, all follow-up programming for the first 3 months is conducted in-clinic (not using the Virtual Clinic feature).

DEVICE

Abbott Infinity DBS systems with the NeuroSphere Virtual Clinic feature (virtual clinic and in-clinic sessions)

Implant and initial programming of the Infinity DBS system for this cohort are conducted according to the sites standard of care. After initial programming, all follow-up programming for the first 3 months is conducted using Virtual Clinic or in-clinic as appropriate.

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Bradley White · Abbott

  • Devyani Nanduri · Abbott Medical Devices Neuromodulation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-24
Primary Completion
2023-12-31
Completion
2024-12-31
FDA Device
Yes

Countries

  • United States
  • Germany
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05269862 on ClinicalTrials.gov