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Mixed Reality Based System to Manage Phantom Pain Phantom Pain for Patients With Lower Limb Amputation (MrMAPP)

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ClinicalTrials.gov Identifier: NCT04529083
Recruitment Status : Recruiting
First Posted : August 27, 2020
Last Update Posted : August 27, 2020
Sponsor:
Collaborator:
The University of Texas at Dallas
Information provided by (Responsible Party):
Thiru Annaswamy, Dallas VA Medical Center

Brief Summary:

The primary goals of this pilot research project are a) to design and develop the a mixed reality based system for managing phantom pain and b) to evaluate the feasibility and preliminary functional outcomes of this system in a sample of patients with lower limb amputation. Findings from this pilot study will serve as preliminary data to inform regarding a fully powered clinical trial to determine the effectiveness and practical implementation of these findings in real-world settings.

Aim1: Design and develop a feasible mixed reality based system to manage phantom pain in patients with lower limb amputation qualifying for on-going mirror therapy.

Hypothesis 1: The investigators hypothesize that the mixed reality based system to manage phantom pain will be feasible and well-received by a sample of patients with lower limb amputation needing mirror therapy.

Aim2: Evaluate functional outcomes in a sample of lower limb amputees (n=10), using this mixed reality based system to manage phantom pain.

Hypothesis 2: Using this system, the investigators hypothesize that patients who participate in the mixed reality based system will show improvements in functional mobility based on performance evaluations and patient reported outcome measures (PROs). The investigators also hypothesize that this mixed reality based system will help to alleviate the phantom pain based on McGill Pain questionnaire and visual analog scale (VAS).


Condition or disease Intervention/treatment Phase
Phantom Limb Pain Device: Mr. MAPP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Pilot study to evaluate feasibility
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Feasibility and Functional Outcomes of a Novel Mixed Reality Based System to Manage Phantom Pain for Patients With Lower Limb Amputation.
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : June 30, 2021

Arm Intervention/treatment
Experimental: Intervention
Mixed Reality System for virtual mirror therapy
Device: Mr. MAPP
Mixed reality device to provide virtual mirror therapy to patients with phantom pain




Primary Outcome Measures :
  1. Change in Numerical Rating Scale [ Time Frame: baseline, 1-month ]
    Pain intensity; 0-10; higher is worse

  2. Change in McGill Pain Questionnaire [ Time Frame: baseline, 1-month ]
    Pain intensity and interference; multiple scales; higher is worse


Secondary Outcome Measures :
  1. Change in Patient Specific Functional Questionnaire [ Time Frame: baseline, 1-month ]
    Patient specific functional questionnaire; multiple scales; higher is better



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men and women, over the age of 18 with lower limb amputations (greater than 3 months post surgery) with phantom limb pain

Exclusion Criteria:

  • Patients with lower limb amputations with open wounds or active infection in residual or contralateral limbs.
  • Patients with history of seizures.
  • Patients with visual (self-reported) or cognitive impairment (assessed by the mini-mental state examination) that interferes with ability to interact with, participate in, and adhere to a computerized rehabilitation system.
  • Any patient with a cardiac event in the last 6 months.
  • Any patient with an active medical issue to minimize risk of exacerbating their condition.
  • Lives more than 60 miles away from the Dallas VA Medical Center
  • Any patient with the motion sickness induced by head mounted displays (HMDs) or immersive environment.
  • Any patient experiencing the motion sickness induced by HMDs during the therapy session can also opt out of the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04529083


Contacts
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Contact: Thiru M Annaswamy, MD 2148570273 thiru.annaswamy@va.gov
Contact: Gargi Raval, MD gargi.raval@va.gov

Locations
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United States, Texas
VA North Texas Health Care System Recruiting
Dallas, Texas, United States, 75216
Principal Investigator: Thiru Annaswamy, MD         
Principal Investigator: Gargi Raval, MD         
Sponsors and Collaborators
Dallas VA Medical Center
The University of Texas at Dallas
Investigators
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Principal Investigator: Gargi Raval, MD North Texas Veterans Healthcare System
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Responsible Party: Thiru Annaswamy, Staff Physician and Professor, Dallas VA Medical Center
ClinicalTrials.gov Identifier: NCT04529083    
Other Study ID Numbers: 18-016
First Posted: August 27, 2020    Key Record Dates
Last Update Posted: August 27, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Data may be shared upon approval from concerned authorities if needed

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Thiru Annaswamy, Dallas VA Medical Center:
mixed reality
phantom limb pain
Additional relevant MeSH terms:
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Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain