Investigation of the Use of Remote Presence Robots in Delivery of Neuromodulation

NCT ID: NCT01283633

Last Updated: 2012-03-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-08-31

Brief Summary

In recent years, robotic devices are becoming more and more common in medical practice. Such devices provide an effective way to communicate within a clinical setting, but recent studies have shown far more diverse uses for these robots, ranging from training future surgeons to diagnoses of patients. In the investigators study, the investigators would like to investigate whether it is effective to employ robotic devices in the administration of neurostimulation treatment. It is the investigators hypothesis that the introduction of robotic devices will only yield minimal if any inaccuracies in a standard neuromodulation treatment protocol. In addition, the investigators also predict a high satisfaction rating from all participants involved in conditions involving the robot.

Detailed Description

Patients with neuromodulation systems implanted for either movement disorders or chronic pain and who require programming of their systems will be approached to enter the study. Those who consent will be consecutively assigned to either the normal standard of care (i.e. programming of their systems with an experienced clinician) or programming of their systems with an inexperienced programmer (nurse) who will be directed by the experienced programmer via the remote presence robot. Both the nurses and the patients will complete questionnaires rating their satisfaction of the programming experience.

They will each only receive one questionnaire at the end of the programming session. There is no other test point.

Conditions

Complications; Neurostimulator; Satisfaction

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

programming with non-experienced nurse

Programming done by an experienced neuromodulation clinician will be compared to the patient satisfaction of a programming session with an inexperienced nurse via remote presence robotics, which will be directed by the experienced clinician

Group Type: EXPERIMENTAL

Neuromodulation

Intervention Type: DEVICE

Neuromodulation as directed via remote presence robotic and experienced clinician for those with neuromodulation systems implanted to treat movement disorders and chronic pain

Interventions

Neuromodulation

Neuromodulation as directed via remote presence robotic and experienced clinician for those with neuromodulation systems implanted to treat movement disorders and chronic pain

Intervention Type: DEVICE

Other Intervention Names

Neurostimulation; deep brain stimulation; spinal cord stimulation

Eligibility Criteria

Inclusion Criteria

• patients with neuromodulation systems, requiring programming
• nurses who have never programmed a neuromodulation system before

Exclusion Criteria

• those who are unwilling to give consent

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nova Scotia Health Authority

OTHER

Sponsor Role: lead

Responsible Party

Ivar Mendez

Neurosurgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivar M Mendez, MD

Role: PRINCIPAL_INVESTIGATOR

Capital Health and Dalhousie University

Locations

Centre for Clinical Research, Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, Canada

Countries

Canada

Other Identifiers

Robotics-Neuromod-Mendez

Identifier Type: -

Identifier Source: org_study_id