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Alternating and Direct Current Stimulation for Neuropathic Eye Pain

Primary Purpose

Eye Pain, Neuropathy, Optic, Cerebral Injury

Status
Recruiting
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
DC-Stimulator Plus (NeuroConn GmbH, Germany)
Sooma direct current stimulator (Sooma, Finland)
Sponsored by
Neil Lagali
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eye Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: persistent eye pain for at least 6 months average eye pain intensity of 4 or more on a 0-10 numerical rating scale naive to transcranial stimulation eye pain having neuropathic-like characteristics Exclusion Criteria: contraindication to transcranial stimulation (i.e., pacemaker, cardioverter defibrillator, neuro-stimulation (brain or spinal cord), bone growth stimulations, indwelling blood pressure monitors, epilepsy, pregnancy) presence of ocular diseases that are the likely cause of pain (i.e., corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, etc.) current participation in another study with an investigational drug or device within one month prior to screening

Sites / Locations

  • Eye Clinic, University Hospital in LinköpingRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Transcranial alternating current stimulation

Transcranial direct current stimulation

Arm Description

Transcranial alternating current stimulation (tACS) device using 50x70 mm electrodes that are placed bilaterally between EEG coordinates C3/C5 for left hemisphere and C4/C6 for right hemisphere (corresponding to S1 and M1 of the eye). The alternating current electrodes are in-phase and have the same peak to peak stimulation 3mA, for 30 minutes duration at 10Hz. An impedance value under 15 ohms is required at all times to ensure patient comfort and safety.

Transcranial direct current stimulation (tDCS) device using 50x70 mm electrodes that has the anodal electrode placed contralateral to most prominent ocular pain or, in the case of bilateral pain symptoms, contralateral to the dominant hand between EEG coordinates C3/C5 for left hemisphere and C4/C6 for right hemisphere (corresponding to S1 and M1 of the eye), and the cathode placed on the patient's upper arm. A current peaking at 3mA will ramp up for 20 secs and be delivered for a total of 20 minutes, thereafter, ramping down for 20s. An impedance value under 15 ohms is required at all times to ensure patient comfort and safety.

Outcomes

Primary Outcome Measures

Change from baseline subjective pain via neuropathic pain symptom inventory for the eye (NPSI-eye) at 1 week
Assesses pain related symptoms on a scale from 0 indicating no pain (better outcome) to10 indicating worst pain imaginable (worse outcome)
Change from baseline subjective pain via neuropathic pain symptom inventory for the eye (NPSI-eye) at 2 weeks
Assesses pain related symptoms on a scale from 0 indicating no pain (better outcome) to10 indicating worst pain imaginable (worse outcome)
Change from baseline subjective pain via neuropathic pain symptom inventory for the eye (NPSI-eye) at 1 month
Assesses pain related symptoms on a scale from 0 indicating no pain (better outcome) to10 indicating worst pain imaginable (worse outcome)
Change from baseline subjective pain effect experiences via Defense and Veteran Pain Rating Scale (DVPRS) at 1 week
Assesses pain related symptoms effecting sleep, stress, disposition, life quality, on a scale from 0 indicating no effect (better outcome) to10 indicating maximum effect (worse outcome)
Change from baseline subjective pain effect experiences via Defense and Veteran Pain Rating Scale (DVPRS) at 2 weeks
Assesses pain related symptoms effecting sleep, stress, disposition, life quality, on a scale from 0 indicating no effect (better outcome) to10 indicating maximum effect (worse outcome)
Change from baseline subjective pain effect experiences via Defense and Veteran Pain Rating Scale (DVPRS) at 1 month
Assesses pain related symptoms effecting sleep, stress, disposition, life quality, on a scale from 0 indicating no effect (better outcome) to10 indicating maximum effect (worse outcome)
Change from baseline subjective mental symptoms via Mental Fatigue Scale (MFS) at 1 week
Assesses mental symptoms on a scale from 0 indicating no effect (better outcome) to 3 indicating extreme effect (worse outcome)
Change from baseline subjective mental symptoms via Mental Fatigue Scale (MFS) at 2 weeks
Assesses mental symptoms on a scale from 0 indicating no effect (better outcome) to 3 indicating extreme effect (worse outcome)
Change from baseline subjective mental symptoms via Mental Fatigue Scale (MFS) at 1 month
Assesses mental symptoms on a scale from 0 indicating no effect (better outcome) to 3 indicating extreme effect (worse outcome)
Change from baseline subjective ocular symptoms and symptom frequency via custom ocular pain questionnaire at 1 week
Ocular pain questionnaire using a visual analog scale with 0 indicating no pain (better outcome) and 10 indicating extreme pain (worse outcome) and frequency measure from 0% indicating never occurring (better outcome) to 100% indicating always occurring (worse outcome)
Change from baseline subjective ocular symptoms and symptom frequency via custom ocular pain questionnaire at 2 weeks
Ocular pain questionnaire using a visual analog scale with 0 indicating no pain (better outcome) and 10 indicating extreme pain (worse outcome) and frequency measure from 0% indicating never occurring (better outcome) to 100% indicating always occurring (worse outcome)
Change from baseline subjective ocular symptoms and symptom frequency via custom ocular pain questionnaire at 1 month
Ocular pain questionnaire using a visual analog scale with 0 indicating no pain (better outcome) and 10 indicating extreme pain (worse outcome) and frequency measure from 0% indicating never occurring (better outcome) to 100% indicating always occurring (worse outcome)
Number of patients with treatment-related adverse events as assessed by ocular pain questionnaire
Ocular pain questionnaire using a visual analog scale with 0 indicating no pain (better outcome) and 10 indicating extreme pain (worse outcome) and frequency measure from 0% indicating never occurring (better outcome) to 100% indicating always occurring (worse outcome)
Change from baseline pupil diameter in millimeters at 1 week
Minimum and maximum pupil diameter in millimeters
Change from baseline pupil velocity in millimeters per second at 1 week
Pupil change velocity in millimeters per second
Change from baseline pupil latency in milliseconds at 1 week
Pupil latency latency in milliseconds

Secondary Outcome Measures

Treatment compliance rate
Evaluation of completed treatment from a total of 15

Full Information

First Posted
June 16, 2023
Last Updated
July 4, 2023
Sponsor
Neil Lagali
Collaborators
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT05931250
Brief Title
Alternating and Direct Current Stimulation for Neuropathic Eye Pain
Official Title
Alternating and Direct Current Stimulation for the Treatment of Chronic Neuropathic Eye Pain and Cerebral Symptoms: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 16, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Neil Lagali
Collaborators
Linkoeping University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical intervention is to test if two forms of transcranial current stimulation, transcranial direct current stimulation (tDCS) or transcranial alternating current stimulation (tACS) can alleviate neuropathic eye pain in a sample of 20 patients. The main aims are: Test if tDCS/tACS can alleviate neuropathic eye pain and/or other cerebral symptoms: brain fatigue, migraine, light sensitivity, etc. Test if one stimulation method is superior to the other Patients will be treated for a total of fifteen 30-minute stimulation sessions, three times a day over a five-day period, each stimulation separated by approximately 4 hours, with either active tACS or tDCS over the scalp corresponding to primary sensory and motor areas. The patients will have questionnaires to monitor subjective experiences and pupillometry before and after treatment to monitor experimental outcomes.
Detailed Description
Brief Summary sufficient

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Pain, Neuropathy, Optic, Cerebral Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transcranial alternating current stimulation
Arm Type
Experimental
Arm Description
Transcranial alternating current stimulation (tACS) device using 50x70 mm electrodes that are placed bilaterally between EEG coordinates C3/C5 for left hemisphere and C4/C6 for right hemisphere (corresponding to S1 and M1 of the eye). The alternating current electrodes are in-phase and have the same peak to peak stimulation 3mA, for 30 minutes duration at 10Hz. An impedance value under 15 ohms is required at all times to ensure patient comfort and safety.
Arm Title
Transcranial direct current stimulation
Arm Type
Experimental
Arm Description
Transcranial direct current stimulation (tDCS) device using 50x70 mm electrodes that has the anodal electrode placed contralateral to most prominent ocular pain or, in the case of bilateral pain symptoms, contralateral to the dominant hand between EEG coordinates C3/C5 for left hemisphere and C4/C6 for right hemisphere (corresponding to S1 and M1 of the eye), and the cathode placed on the patient's upper arm. A current peaking at 3mA will ramp up for 20 secs and be delivered for a total of 20 minutes, thereafter, ramping down for 20s. An impedance value under 15 ohms is required at all times to ensure patient comfort and safety.
Intervention Type
Device
Intervention Name(s)
DC-Stimulator Plus (NeuroConn GmbH, Germany)
Intervention Description
Transcranial alternating current stimulation
Intervention Type
Device
Intervention Name(s)
Sooma direct current stimulator (Sooma, Finland)
Intervention Description
Transcranial direct current stimulation
Primary Outcome Measure Information:
Title
Change from baseline subjective pain via neuropathic pain symptom inventory for the eye (NPSI-eye) at 1 week
Description
Assesses pain related symptoms on a scale from 0 indicating no pain (better outcome) to10 indicating worst pain imaginable (worse outcome)
Time Frame
through treatment completion, 1 week
Title
Change from baseline subjective pain via neuropathic pain symptom inventory for the eye (NPSI-eye) at 2 weeks
Description
Assesses pain related symptoms on a scale from 0 indicating no pain (better outcome) to10 indicating worst pain imaginable (worse outcome)
Time Frame
through treatment completion, 2 weeks
Title
Change from baseline subjective pain via neuropathic pain symptom inventory for the eye (NPSI-eye) at 1 month
Description
Assesses pain related symptoms on a scale from 0 indicating no pain (better outcome) to10 indicating worst pain imaginable (worse outcome)
Time Frame
through treatment completion, 1 month
Title
Change from baseline subjective pain effect experiences via Defense and Veteran Pain Rating Scale (DVPRS) at 1 week
Description
Assesses pain related symptoms effecting sleep, stress, disposition, life quality, on a scale from 0 indicating no effect (better outcome) to10 indicating maximum effect (worse outcome)
Time Frame
through treatment completion, 1 week
Title
Change from baseline subjective pain effect experiences via Defense and Veteran Pain Rating Scale (DVPRS) at 2 weeks
Description
Assesses pain related symptoms effecting sleep, stress, disposition, life quality, on a scale from 0 indicating no effect (better outcome) to10 indicating maximum effect (worse outcome)
Time Frame
through treatment completion, 2 weeks
Title
Change from baseline subjective pain effect experiences via Defense and Veteran Pain Rating Scale (DVPRS) at 1 month
Description
Assesses pain related symptoms effecting sleep, stress, disposition, life quality, on a scale from 0 indicating no effect (better outcome) to10 indicating maximum effect (worse outcome)
Time Frame
through treatment completion, 1 month
Title
Change from baseline subjective mental symptoms via Mental Fatigue Scale (MFS) at 1 week
Description
Assesses mental symptoms on a scale from 0 indicating no effect (better outcome) to 3 indicating extreme effect (worse outcome)
Time Frame
through treatment completion, 1 week
Title
Change from baseline subjective mental symptoms via Mental Fatigue Scale (MFS) at 2 weeks
Description
Assesses mental symptoms on a scale from 0 indicating no effect (better outcome) to 3 indicating extreme effect (worse outcome)
Time Frame
through treatment completion, 2 weeks
Title
Change from baseline subjective mental symptoms via Mental Fatigue Scale (MFS) at 1 month
Description
Assesses mental symptoms on a scale from 0 indicating no effect (better outcome) to 3 indicating extreme effect (worse outcome)
Time Frame
through treatment completion, 1 month
Title
Change from baseline subjective ocular symptoms and symptom frequency via custom ocular pain questionnaire at 1 week
Description
Ocular pain questionnaire using a visual analog scale with 0 indicating no pain (better outcome) and 10 indicating extreme pain (worse outcome) and frequency measure from 0% indicating never occurring (better outcome) to 100% indicating always occurring (worse outcome)
Time Frame
through treatment completion, 1 week
Title
Change from baseline subjective ocular symptoms and symptom frequency via custom ocular pain questionnaire at 2 weeks
Description
Ocular pain questionnaire using a visual analog scale with 0 indicating no pain (better outcome) and 10 indicating extreme pain (worse outcome) and frequency measure from 0% indicating never occurring (better outcome) to 100% indicating always occurring (worse outcome)
Time Frame
through treatment completion, 1 month
Title
Change from baseline subjective ocular symptoms and symptom frequency via custom ocular pain questionnaire at 1 month
Description
Ocular pain questionnaire using a visual analog scale with 0 indicating no pain (better outcome) and 10 indicating extreme pain (worse outcome) and frequency measure from 0% indicating never occurring (better outcome) to 100% indicating always occurring (worse outcome)
Time Frame
through treatment completion, 1 month
Title
Number of patients with treatment-related adverse events as assessed by ocular pain questionnaire
Description
Ocular pain questionnaire using a visual analog scale with 0 indicating no pain (better outcome) and 10 indicating extreme pain (worse outcome) and frequency measure from 0% indicating never occurring (better outcome) to 100% indicating always occurring (worse outcome)
Time Frame
through treatment completion, 1 month
Title
Change from baseline pupil diameter in millimeters at 1 week
Description
Minimum and maximum pupil diameter in millimeters
Time Frame
through treament completion, 1 week
Title
Change from baseline pupil velocity in millimeters per second at 1 week
Description
Pupil change velocity in millimeters per second
Time Frame
through treament completion, 1 week
Title
Change from baseline pupil latency in milliseconds at 1 week
Description
Pupil latency latency in milliseconds
Time Frame
through treament completion, 1 week
Secondary Outcome Measure Information:
Title
Treatment compliance rate
Description
Evaluation of completed treatment from a total of 15
Time Frame
through study completion, 1 year
Other Pre-specified Outcome Measures:
Title
Beta coefficients for participant demographics (sex, age, race/ethnicity) in regression model predicting adherence to treatment protocol
Description
Exploratory regression analysis to identify associations between demographic variables and number of treatment sessions completed
Time Frame
through study completion, 1 year
Title
Beta coefficients for participant demographics (sex, age, race/ethnicity) in regression model predicting change in pain (Numerical Rating Scale)
Description
Exploratory regression analysis to identify associations between demographic variables and change in pain ratings (before vs. after stimulation treatment)
Time Frame
through study completion, 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: persistent eye pain for at least 6 months average eye pain intensity of 4 or more on a 0-10 numerical rating scale naive to transcranial stimulation eye pain having neuropathic-like characteristics Exclusion Criteria: contraindication to transcranial stimulation (i.e., pacemaker, cardioverter defibrillator, neuro-stimulation (brain or spinal cord), bone growth stimulations, indwelling blood pressure monitors, epilepsy, pregnancy) presence of ocular diseases that are the likely cause of pain (i.e., corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, etc.) current participation in another study with an investigational drug or device within one month prior to screening
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neil Lagali, PhD
Phone
+4613286680
Email
neil.lagali@liu.se
First Name & Middle Initial & Last Name or Official Title & Degree
Magnus Thordstein, MD
Email
magnus.thordstein@liu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Neil Lagali, PhD
Organizational Affiliation
RegionÖstergötland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye Clinic, University Hospital in Linköping
City
Linköping
State/Province
Other / Non-US
ZIP/Postal Code
58183
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Neil Lagali
Phone
+4613286680
Email
neil.lagali@liu.se

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27089999
Citation
Qazi Y, Hurwitz S, Khan S, Jurkunas UV, Dana R, Hamrah P. Validity and Reliability of a Novel Ocular Pain Assessment Survey (OPAS) in Quantifying and Monitoring Corneal and Ocular Surface Pain. Ophthalmology. 2016 Jul;123(7):1458-68. doi: 10.1016/j.ophtha.2016.03.006. Epub 2016 Apr 16.
Results Reference
background
PubMed Identifier
30883524
Citation
Farhangi M, Feuer W, Galor A, Bouhassira D, Levitt RC, Sarantopoulos CD, Felix ER. Modification of the Neuropathic Pain Symptom Inventory for use in eye pain (NPSI-Eye). Pain. 2019 Jul;160(7):1541-1550. doi: 10.1097/j.pain.0000000000001552.
Results Reference
background
PubMed Identifier
29283468
Citation
Sivanesan E, Levitt RC, Sarantopoulos CD, Patin D, Galor A. Noninvasive Electrical Stimulation for the Treatment of Chronic Ocular Pain and Photophobia. Neuromodulation. 2018 Dec;21(8):727-734. doi: 10.1111/ner.12742. Epub 2017 Dec 28.
Results Reference
background

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Alternating and Direct Current Stimulation for Neuropathic Eye Pain

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