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INSTANT: Intranasal Neurostimulation in Ameliorating Symptoms of Neuropathic Corneal Pain

Sponsor
Tufts Medical Center (Other)
Overall Status
Suspended
CT.gov ID
NCT03674892
Collaborator
(none)
45
Enrollment
1
Location
56.1
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: TrueTear™ intranasal neurostimulator (ITN)
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
non-randomized, open-label, single arm pilot trialnon-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 :
Sep 28, 2018
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Jun 1, 2023

Outcome Measures

Primary Outcome Measures

  1. Change in pain score measured by the Visual Analogue Scale (VAS) after intranasal neurostimulator (ITN) stimulation [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 [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 [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 [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) [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 [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 [90 days]

    Intraocular pressure will be measured by an applanation tonometer used on slit lamp (Goldmann) in mmHg.

  7. Tolerability of ITN [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 [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 [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])

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Tufts Medical Center Boston Massachusetts United States 02111

Sponsors and Collaborators

  • Tufts Medical Center

Investigators

  • Principal Investigator: Pedram Hamrah, MD, Tufts Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT03674892
Other Study ID Numbers:
  • 12978
First Posted:
Sep 18, 2018
Last Update Posted:
Jan 24, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Keywords provided by Tufts Medical Center
Intranasal Neurostimulation

Study Results

No Results Posted as of Jan 24, 2022