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Trial record 7 of 20 for:    Recruiting, Not yet recruiting, Available Studies | Pain | Neurostimulation

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

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ClinicalTrials.gov Identifier: NCT03674892
Recruitment Status : Recruiting
First Posted : September 18, 2018
Last Update Posted : December 31, 2018
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

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.

Condition or disease Intervention/treatment Phase
Cornea Device: TrueTear™ intranasal neurostimulator (ITN) Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Intervention Model Description: non-randomized, open-label, single arm pilot trial
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessing the Efficacy of Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : April 2021

Intervention Details:
  • 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.


Primary Outcome Measures :
  1. 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])


Secondary Outcome Measures :
  1. 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.

  2. 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])

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Tolerability of ITN [ Time Frame: 90 days ]
    Directed questioning about itching, burning sensation, and foreign body sensation will be done to assess tolerability

  8. 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.

  9. 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])



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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

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): NCT03674892


Contacts
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Contact: Pedram Hamrah, MD 617-636-5720 phamrah@tuftsmedicalcenter.org
Contact: Nancy Gee, MPH 617-636-5489 ngee@tuftsmedicalcenter.org

Locations
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United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Nancy Gee, MPH    617-636-5489    ngee@tuftsmedicalcenter.org   
Contact: Michael Dixon    617-636-1051    mdixon3@tuftsmedicalcenter.org   
Principal Investigator: Pedram Hamrah, MD         
Sponsors and Collaborators
Tufts Medical Center
Investigators
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Principal Investigator: Pedram Hamrah, MD Tufts Medical Center

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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT03674892     History of Changes
Other Study ID Numbers: 12978
First Posted: September 18, 2018    Key Record Dates
Last Update Posted: December 31, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Tufts Medical Center:
Intranasal Neurostimulation