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

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Information provided by:

Dallas VA Medical Center

Last updated:

08/27/2020

Trial identifier:

NCT04529083

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Simplified Study Description Detailed Study Description

Study Description

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).

Study Recruitment Status:

Glossary term:

Recruitment status

Not yet recruiting: The study has not started recruiting participants. Recruiting: The study is currently recruiting participants. Enrolling by invitation: The study is selecting its participants from a population, or group of people, decided on by the researchers in advance. These studies are not open to everyone who meets the eligibility criteria but only to people in that particular population, who are specifically invited to participate. Active, not recruiting: The study is ongoing, and participants are receiving an intervention or being examined, but potential participants are not currently being recruited or enrolled. Suspended: The study has stopped early but may start again. Terminated: The study has stopped early and will not start again. Participants are no longer being examined or treated. Completed: The study has ended normally, and participants are no longer being examined or treated (that is, the last participant's last visit has occurred). Withdrawn: The study stopped early, before enrolling its first participant. Unknown: A study on ClinicalTrials.gov whose last known status was recruiting; not yet recruiting; or active, not recruiting but that has passed its completion date, and the status has not been last verified within the past 2 years.

Recruiting

Age Eligible:

Glossary term:

Age

A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups: The age groups are: Child (birth–17) Adult (18–64) Older adult (65+)

Sexes Eligible:

Glossary term:

Sex

A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.

All

Study Accepts Healthy Volunteers:

Glossary term:

Accepts Healthy Volunteers

A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.

Intervention Being Studied:

Device: Mr. MAPP

Type of Study:

Glossary term:

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access. Interventional studies (clinical trials): A type of clinical study in which participants are assigned to groups that receive one or more intervention/treatment (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. The assignments are determined by the study's protocol. Participants may receive diagnostic, therapeutic, or other types of interventions. Observational studies: A type of clinical study in which participants are identified as belonging to study groups and are assessed for biomedical or health outcomes. Participants may receive diagnostic, therapeutic, or other types of interventions, but the investigator does not assign participants to a specific intervention/treatment. A patient registry is a type of observational study. Expanded access: A way for patients with serious diseases or conditions who cannot participate in a clinical trial to gain access to a medical product that has not been approved by the U.S. Food and Drug Administration (FDA). Also called compassionate use. There are different expanded access types.

Interventional

Enrollment (Anticipated):

Glossary term:

Enrollment

The number of participants in a clinical study. The "estimated" enrollment is the target number of participants that the researchers need for the study.

10 participants

Sponsor:

Glossary term:

Sponsor

The organization or person who initiates the study and who has authority and control over the study.

Dallas VA Medical Center

Study Locations (1):

VA North Texas Health Care System

Dallas, Texas, United States, 75216

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Study Start Date (Actual):

Glossary term:

Study start date

The actual date on which the first participant was enrolled in a clinical study. The "estimated" study start date is the date that the researchers think will be the study start date.

May 21, 2018

Study Completion (Anticipated):

Glossary term:

Study completion date

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "estimated" study completion date is the date that the researchers think will be the study completion date.

June 30, 2021

Study Contacts:

Thiru M Annaswamy, MD

2148570273

thiru.annaswamy@va.gov

Gargi Raval, MD

gargi.raval@va.gov

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Age Eligible: Glossary term: Age A type of eligibility criteria that indicates the age a person must be to participate in a clinical study. This may be indicated by a specific age or the following age groups: The age groups are: Child (birth–17) Adult (18–64) Older adult (65+)

Sexes Eligible: Glossary term: Sex A type of eligibility criteria that indicates the sex of people who may participate in a clinical study (all, female, male). Sex is a person's classification as female or male based on biological distinctions. Sex is distinct from gender-based eligibility.

Study Accepts Healthy Volunteers: Glossary term: Accepts Healthy Volunteers A type of eligibility criteria that indicates whether people who do not have the condition/disease being studied can participate in that clinical study.