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Research Protocol for Karuna Labs Inc.: Safety and Efficacy of Virtual Reality Graded Motor Imagery for Chronic Pain

NCT04060875 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 24

Last updated 2021-06-11

No results posted yet for this study

Summary

The purpose of this study is to investigate, in two phases: (1) the feasibility and safety of Virtual Embodiment Therapy in treating chronic pain of lower back and upper limbs and (2) the efficacy of Virtual Embodiment Therapy on chronic pain disorders of the lower back and upper limbs. In phase 1, we will investigate the feasibility, safety, and side effects related to this treatment by assessing simulator sickness. In phase 2, which in contingent on successful completion of phase 1, we will assess symptoms of pain specific to the region treated, fear and avoidance behavior, and depression symptoms before and after 8 sessions of treatment with Virtual Embodiment Therapy in order to assess efficacy. This study will be single-blinded, because the participation of the clinician is necessary to ensure proper administration of the therapy, as well as to monitor in the event of adverse reactions.

Conditions

  • Chronic Pain
  • Low Back Pain
  • Fibromyalgia
  • Upper Extremity Dysfunction
  • Complex Regional Pain Syndromes
  • Phantom Limb Pain
  • Rheumatoid Arthritis
  • Carpal Tunnel Syndrome
  • Repetitive Strain Injury

Interventions

DEVICE

Karuna Labs Virtual Reality Software

The subjects will engage in the three therapeutic modules: laterality, motor imagery, and 'mirroring.' The decision of which module to employ will be based on the subject's readiness and comfort on a case-by-case basis. A subject visit can be expected to last 40 minutes, with enough time to complete PHQ-9, and to accustom to the virtual reality setup by playing in a non-therapeutic virtual environment should they choose to do so. Time in the virtual reality is expected to last approximately 20 minutes per session.

Sponsors & Collaborators

  • Karuna Labs Inc.

    lead INDUSTRY

Principal Investigators

  • Michael Trujillo, PhD · Vice President of Clinical Affairs

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-21
Primary Completion
2021-06-01
Completion
2021-06-01

Countries

  • United States

Study Locations

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Entities

Diseases

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 NCT04060875 on ClinicalTrials.gov