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| Name | Class |
|---|---|
| Linkoeping University | OTHER_GOV |
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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:
The patients will have questionnaires to monitor subjective experiences and pupillometry before and after treatment to monitor experimental outcomes.
Brief Summary sufficient
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transcranial alternating current stimulation | Experimental | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DC-Stimulator Plus (NeuroConn GmbH, Germany) | Device | Transcranial alternating current stimulation |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | through treatment completion, 1 week |
| 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) | through treatment completion, 2 weeks |
| 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) | through treatment completion, 1 month |
| 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) | through treatment completion, 1 week |
| 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) | through treatment completion, 2 weeks |
| Change from baseline subjective pain effect experiences via Defense and Veteran Pain Rating Scale (DVPRS) at 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment compliance rate | Evaluation of completed treatment from a total of 15 | through study completion, 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Beta coefficients for participant demographics (sex, age, race/ethnicity) in regression model predicting adherence to treatment protocol | Exploratory regression analysis to identify associations between demographic variables and number of treatment sessions completed | through study completion, 1 year |
| Beta coefficients for participant demographics (sex, age, race/ethnicity) in regression model predicting change in pain (Numerical Rating Scale) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Neil Lagali, PhD | Contact | +4613286680 | neil.lagali@liu.se | |
| Magnus Thordstein, MD | Contact | magnus.thordstein@liu.se |
| Name | Affiliation | Role |
|---|---|---|
| Neil Lagali, PhD | RegionÖstergötland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Clinic, University Hospital in Linköping | Recruiting | Linköping | Other / Non-US | 58183 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27089999 | Background | 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. | |
| 30883524 | Background |
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| ID | Term |
|---|---|
| D058447 | Eye Pain |
| D009901 | Optic Nerve Diseases |
| D001930 | Brain Injuries |
| ID | Term |
|---|---|
| D005132 | Eye Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Sooma direct current stimulator (Sooma, Finland) | Device | Transcranial direct current stimulation |
|
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) |
| through treatment completion, 1 month |
| 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) | through treatment completion, 1 week |
| 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) | through treatment completion, 2 weeks |
| 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) | through treatment completion, 1 month |
| 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) | through treatment completion, 1 week |
| 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) | through treatment completion, 1 month |
| 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) | through treatment completion, 1 month |
| 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) | through treatment completion, 1 month |
| Change from baseline pupil diameter in millimeters at 1 week | Minimum and maximum pupil diameter in millimeters | through treament completion, 1 week |
| Change from baseline pupil velocity in millimeters per second at 1 week | Pupil change velocity in millimeters per second | through treament completion, 1 week |
| Change from baseline pupil latency in milliseconds at 1 week | Pupil latency latency in milliseconds | through treament completion, 1 week |
Exploratory regression analysis to identify associations between demographic variables and change in pain ratings (before vs. after stimulation treatment) |
| through study completion, 1 year |
| 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. |
| 29283468 | Background | 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. |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |