Cerebral Injury, Eye Pain, Neuropathy, Optic
Conditions
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
Interventions
DEVICEDC-Stimulator Plus (NeuroConn GmbH, Germany)
Transcranial alternating current stimulation
DEVICESooma direct current stimulator (Sooma, Finland)
Transcranial direct current stimulation
Sponsors
Neil Lagali
University Hospital, Linkoeping
Linkoeping University
Region Östergötland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline subjective pain via neuropathic pain symptom inventory for the eye (NPSI-eye) at 1 week | through treatment completion, 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 | through treatment completion, 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 | through treatment completion, 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 | through treatment completion, 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 | through treatment completion, 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 | through treatment completion, 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 | through treatment completion, 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 | through treatment completion, 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 | through treatment completion, 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 | through treatment completion, 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 | through treatment completion, 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) |
| Change from baseline subjective ocular symptoms and symptom frequency via custom ocular pain questionnaire at 1 month | through treatment completion, 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 | through treatment completion, 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) |
| Change from baseline pupil diameter in millimeters at 1 week | through treament completion, 1 week | Minimum and maximum pupil diameter in millimeters |
| Change from baseline pupil velocity in millimeters per second at 1 week | through treament completion, 1 week | Pupil change velocity in millimeters per second |
| Change from baseline pupil latency in milliseconds at 1 week | through treament completion, 1 week | Pupil latency latency in milliseconds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment compliance rate | through study completion, 1 year | Evaluation of completed treatment from a total of 15 |
Countries
Sweden
Contacts
PRINCIPAL_INVESTIGATORNeil Lagali, PhD
RegionÖstergötland
Outcome results
None listed