Near-infrared Fluorescence Lymphatic Imaging Assessment of Lymphatic Response to Pneumatic Back/Neck Lymphatic Drainage Delivered by a Pneumatic Manual Lymphatic Drainage Device

The purpose of this study is to objectively assess lymphatic function before, during, and immediately after Neuroglide treatment in lower trunk and leg lymphatic vessels, torso, axillary regions, inguinal regions, upper extremities, and cervical/neck and to determine any VAS (Visual Analog Scale, a commonly used measure of pain perception) score change after Neuroglide treatment.

Study Overview

• Status: Completed
• Conditions: Back Pain; Neck Pain
• Intervention / Treatment: Drug: Indocyanine green (ICG) dye; Device: NIRF-LI imaging; Device: Neuroglide pad

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Melissa B Aldrich, PhD, MBA; Phone Number: 713-500-3565; Email: Melissa.B.Aldrich@uth.tmc.edu
• Study Contact Backup: Name: John Rasmussen; Phone Number: 713-500-3393; Email: John.Rasmussen@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • The University of Texas Health Science Center at Houston

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• ambulatory and possess all four limbs
• Female participants of childbearing potential must have a negative urine pregnancy test within 36 hours prior to study drug administration
• Female participants of childbearing potential must agree to use a medically accepted method of contraception for a period of one month following each imaging session in the study
• Weight less than 400 lbs

Exclusion Criteria:

• Women who are pregnant or breast-feeding
• Persons who are allergic to iodine or indocyanine green
• Heart failure, poorly controlled kidney disease (glomerular filtration rate <30 mls per minute), hypoproteinemia, pulmonary hypertension, or hypothyroidism
• Any circumstance where increased lymphatic or venous return is undesirable

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Pneumatic Compression Therapy (PCT)

Drug: Indocyanine green (ICG) dye; ICG (25 mg vial) will be reconstituted with 10 ml sterile water provided by the manufacturer; further dilutions will be made in sterile saline just prior to administration. The final concentration of 0.32 millimolar (mM) will provide 25 μg ICG/injection, with each injection of 0.1 cc to be made . Up to 30 intradermal injections using conventional 30- or 31-gauge needles will be administered to each subject, for a maximum dose of 750 ug ICG, over 200 times less than the maximum allowed dose. Injection sites will be cleaned with alcohol wipes before intradermal injection.; Device: NIRF-LI imaging; Near-infrared fluorescence lymphatic imaging (NIRF-LI) imaging will be done to assess the drainage of ICG laden lymph from ICG injection sites toward regional nodal basins for 60 minutes before, during and after the Neuroglide pad treatment; Device: Neuroglide pad; After injection of Indocyanine green (ICG) dye and NIRF-LI imaging the subject will lie on the Neuroglide pad for the one-hour PCT treatment session.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in frequency of lymphatic pulsing as assessed by the number of lymphatic pulses per minute in each region imaged	Baseline, during Neuroglide treatment ( 1 hour after NIRF-LI imaging ), 1 hour after PCT treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in pain as assessed by the Visual Analog Scale (VAS)	This is scored from 1(no pain)-10( worst pain possible) a higher number indicating more pain	Baseline, 1 hour after PCT treatment, 4-8 weeks after imaging for data analysis completion

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: Eva MedTech, Inc.
• Investigators: Principal Investigator: Melissa B Aldrich, PhD, MBA, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2023
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 1, 2023

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: July 7, 2023
• First Posted (Actual): July 14, 2023

Study Record Updates

• Last Update Posted (Estimated): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 12, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: HSC-MS-23-0093

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: Yes