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

NCT01283633 | Completed Phase 4

• 1 other identifier: Robotics-Neuromod-Mendez
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Complications; Neurostimulator; Satisfaction

Keywords

neuromodulation; remote presence robotics

Outcome Measures

Primary Outcomes (1)

• Patient Satisfaction

  The questionnaire will take approximately 10 minutes to complete. There are no other follow-ups required. This is the only study time commitment for the patients above the usual standard of care.

  Patients will complete the questionnaire once following the neuromodulation therapy. Day 1

Secondary Outcomes (1)

• Nursing satisfaction questionnaire

  Immediately following the neuromodulation session, the nurse will complete one questionnnaire. Day 1.

Study Arms (1)

programming with non-experienced nurse

EXPERIMENTAL

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

Device: Neuromodulation

Interventions

Neuromodulation DEVICE

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

Also known as: Neurostimulation, deep brain stimulation, spinal cord stimulation

programming with non-experienced nurse

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• those who are unwilling to give consent

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Study Sites (1)

Centre for Clinical Research, Queen Elizabeth II Health Sciences Centre

Halifax, Nova Scotia, B3H 1V7, Canada

Location

MeSH Terms

Conditions

Personal Satisfaction

Interventions

Transcutaneous Electric Nerve Stimulation; Deep Brain Stimulation; Spinal Cord Stimulation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Surgical Procedures, Operative

Study Officials

• Ivar M Mendez, MD

  Capital Health and Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Neurosurgeon

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: January 26, 2011
• Study Start: February 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 12, 2012

Record last verified: 2012-03

Locations

CA (1)