Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain (INSTANT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03674892
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : March 3, 2021
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

Tracking Information
First Submitted Date  ICMJE September 12, 2018
First Posted Date  ICMJE September 18, 2018
Last Update Posted Date March 3, 2021
Actual Study Start Date  ICMJE September 28, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2018)
Change in pain score measured by the Visual Analogue Scale (VAS) after intranasal neurostimulator (ITN) stimulation [ Time Frame: 90 days ]
Visual Analogue Scale (VAS) questionnaire is single-item scale for pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])
Original Primary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
Change to overall pain by the Visual Analogue Scale (VAS) after intranasal neurostimulator (ITN) stimulation [ Time Frame: 90 days ]
Visual Analogue Scale (VAS) questionnaire - Symptoms of ocular comfort and dryness will be graded for each eye on a scale of 0-100, where 0=extremely uncomfortable, extremely dry and 100=excellent comfort, no dryness. An average rating will be provided for the morning, afternoon and evening.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 27, 2018)
  • Corneal nerve density measured by laser in vivo confocal microscopy (IVCM) in mm/mm2 [ Time Frame: 90 days ]
    IVCM is a non-invasive, high-resolution, real-time imaging technique that allows the study of corneal nerve morphology.
  • Response to proparacaine drops based on Visual Analogue Scale (VAS) scores [ Time Frame: 90 days ]
    The level of pain will be measured on a visual analogue faces scale before and after application of a proparacaine drop. Visual Analogue Scale (VAS) questionnaire is single-item scale for pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])
  • Quality of Life (QoL) based on the multidimensional ocular pain questionnaire [ Time Frame: 90 days ]
    Ocular Pain Assessment Survey (OPAS) is a multidimensional 32-questions, 8-domain questionnaire using numerical rating scales to assess eye pain intensity (worse eye) in the past 24 hours and 2 weeks (worst, least and average pain intensity), frequency of eye and non-eye pain (past 24 hours and 2 weeks), non-eye pain intensity (past 24 hours and 2 weeks), impact on QoL, pre-occupation with eye and non-eye pain, aggravating factors and associated factors.
  • Change in quality of life as measured daily with Impact of Dry Eye on Everyday Life (IDEEL) [ Time Frame: 90 days ]
    IDEEL Quality of Life Questionnaire is a 27-item questionnaire, designed specifically for DED and is divided into three parts. It assesses the quality of life in three aspects of life for the previous 2 weeks: daily activities, work and feelings. The quality of life is assessed on a scale of 0-5, with zero being inability to do the activity. The score is calculated between 0 - 100 with higher scores indicating a better quality of life.
  • Micro-neuroma density measured by laser in vivo confocal microscopy (IVCM) in unit/ mm2 [ Time Frame: 90 days ]
    IVCM is a non-invasive, high-resolution, real-time imaging technique that allows the study of corneal nerve morphology.
  • Change in the intraocular pressure (IOP) measured in mmHg [ Time Frame: 90 days ]
    Intraocular pressure will be measured by an applanation tonometer used on slit lamp (Goldmann) in mmHg.
  • Tolerability of ITN [ Time Frame: 90 days ]
    Directed questioning about itching, burning sensation, and foreign body sensation will be done to assess tolerability
  • Changes in the current systemic medications [ Time Frame: 90 days ]
    Questionnaires regarding changes or reduction in the current systemic medications will be applied and used as a clinical effective parameter.
  • Response to hyperosmolar drops based on Visual Analogue Scale (VAS) scores [ Time Frame: 90 days ]
    The hypersensitivity to hyperosmolarity will be examined by applying a 5% sodium chloride drop on the conjunctival fornix of both eyes. The level of pain will be measured on a visual analogue faces scale before and after application of a 5% sodium chloride drop.Visual Analogue Scale (VAS) questionnaire is single-item scale for pain intensity, the scale is most commonly anchored by "no pain" (score of 0) and "pain as bad as it could be" or "worst imaginable pain" (score of 100 [100-mm scale])
Original Secondary Outcome Measures  ICMJE
 (submitted: September 14, 2018)
  • Change to overall pain by the Visual Analogue Scale (VAS) after daily ITN stimulation [ Time Frame: 45 days ]
    Visual Analogue Scale (VAS) questionnaire - Symptoms of ocular comfort and dryness will be graded for each eye on a scale of 0-100, where 0=extremely uncomfortable, extremely dry and 100=excellent comfort, no dryness. An average rating will be provided for the morning, afternoon and evening.
  • Change to overall pain by the Visual Analogue Scale (VAS) after daily ITN stimulation [ Time Frame: 90 days ]
    Visual Analogue Scale (VAS) questionnaire - Symptoms of ocular comfort and dryness will be graded for each eye on a scale of 0-100, where 0=extremely uncomfortable, extremely dry and 100=excellent comfort, no dryness. An average rating will be provided for the morning, afternoon and evening.
  • Change in quality of life as measured daily with Ocular Pain Assessment Survey (OPAS) [ Time Frame: 90 days ]
    OPAS Questionnaire: 27-item quantitative questionnaire designed to provide an assessment of the symptoms and quality of life effect of ocular pain. The 27 items of the OPAS questionnaire are graded on a scale of 0 to 10, or 10 to 100, where 0 indicates none and 10 or 100 indicate maximum.
  • Change in quality of life as measured daily with Impact of Dry Eye on Everyday Life (IDEEL) [ Time Frame: 90 days ]
    IDEEL Quality of Life Questionnaire is a 27-item questionnaire, designed specifically for DED and is divided into three parts. It assesses the quality of life in three aspects of life for the previous 2 weeks: daily activities, work and feelings. The quality of life is assessed on a scale of 0-5, with zero being inability to do the activity. The score is calculated between 0 - 100 with higher scores indicating a better quality of life.
  • The primary safety variable monitored will be the occurrence of adverse events. [ Time Frame: 90 days ]
  • Tolerability of ITN [ Time Frame: 90 days ]
    Directed questioning about itching, burning sensation, and foreign body sensation will be done to assess tolerability
  • Change in response to hypertonic solution [ Time Frame: 90 days ]
  • Change in response to proparacaine challenge test [ Time Frame: 90 days ]
  • Change in the intraocular pressure (IOP) measured in each visit [ Time Frame: 90 days ]
  • Changes in the current systemic medications [ Time Frame: 90 days ]
    Questionnaires regarding changes or reduction in the current systemic medications will be applied and used as a clinical effective parameter.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain
Official Title  ICMJE Assessing the Efficacy of Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain
Brief Summary This study is a prospective, interventional, open-label, single arm, non-randomized trial treating 30 patients with peripheral or mixed neuropathic corneal pain at their baseline exam and following 45 days and 90 days of daily use with the TrueTear™ ITN device.
Detailed Description

The investigators hypothesize that the stimulation through the ethmoidal nerve in the nasal cavity may have an inhibitory effect on the primary TG interneurons and block the ocular pain signaling to the brain.

The investigators propose a non-randomized, open-label, single arm pilot trial for treatment of neuropathic corneal pain (NCP) with ITN with the following specific aims:

Specific Aims:

  1. To elucidate the efficacy of ITN in ameliorating pain among neuropathic corneal pain patients.
  2. To elucidate the safety, efficacy, longevity of ITN in ameliorating pain among neuropathic corneal pain patients during a 90-day period with daily use.
  3. To assess quality of life changes by treating neuropathic corneal pain with ITN during a 90-day period with daily use.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
non-randomized, open-label, single arm pilot trial
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Cornea
Intervention  ICMJE Device: TrueTear™ intranasal neurostimulator (ITN)
Subject will place the tips of the ITN into both nostrils simultaneously. Subject will be asked to apply it for 3 minutes [could be modified if need be], daily.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 14, 2018)
45
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age >22
  2. Ability to consent to study.
  3. Symptoms of neuropathic corneal pain for at least 3 months, such as burning, stinging, light sensitivity, discomfort or pain.
  4. Positive in vivo confocal microscopy (IVCM) findings for NCP such as presence of microneuromas and decreased nerve density.
  5. Fifty percent or more relief of pain or discomfort after instillation of Proparacaine eye drops as measured by the Visual Analogue Scale (VAS).

Exclusion Criteria:

  1. Clinically significant acute ocular surface diseases, such as active infectious keratitis or recent ocular surgery in the past 3 months.
  2. Chronic or recurrent epistaxis, coagulation disorders.
  3. Nasal or sinus surgery or significant trauma to the nose.
  4. Severe nasal airway obstruction or vascularized nasal polyps.
  5. Cardiac demand pacemaker, implanted defibrillator, or other implanted electronic device in the head or neck.
  6. Chronic or recurrent nosebleeds
  7. Bleeding disorder
  8. Known hypersensitivity (allergy) to the hydrogel material
  9. Disabling arthritis, neuropathy, or limited motor coordination affecting self-handling of the device.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pedram Hamrah, MD 617-636-5720 phamrah@tuftsmedicalcenter.org
Contact: Nancy Gee, MPH 617-636-5489 ngee@tuftsmedicalcenter.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03674892
Other Study ID Numbers  ICMJE 12978
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tufts Medical Center
Study Sponsor  ICMJE Tufts Medical Center
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pedram Hamrah, MD Tufts Medical Center
PRS Account Tufts Medical Center
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP