COMPLETEDNA

Alternating and Direct Current Stimulation for Neuropathic Eye Pain

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.

Sponsor

Neil Lagali

Enrollment

20 participants

Sites

1 locations

Start Date

June 2023

Completion

December 2024

Eye PainNeuropathy, OpticCerebral InjuryDC-Stimulator Plus (NeuroConn GmbH, Germany)Sooma direct current stimulator (Sooma, Finland)

Enrollment & Timeline

Completed

Target N

participants

Sites

locations

Duration

18 months

total trial span

Rate

pts/month needed

At 1 sites, each site needs to enroll approximately 1.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Modification of the Neuropathic Pain Symptom Inventory for use in eye pain (NPSI-Eye).

Farhangi Monika, Feuer William, Galor Anat et al.Pain2020

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Fetching protocol from ClinicalTrials.gov…

COMPLETEDNA

Alternating and Direct Current Stimulation for Neuropathic Eye Pain

Sponsor

Neil Lagali

Enrollment

20 participants

Sites

1 locations

Start Date

June 2023

Completion

December 2024

Eye PainNeuropathy, OpticCerebral InjuryDC-Stimulator Plus (NeuroConn GmbH, Germany)Sooma direct current stimulator (Sooma, Finland)

Enrollment & Timeline

Completed

Target N

participants

Sites

locations

Duration

18 months

total trial span

Rate

pts/month needed

At 1 sites, each site needs to enroll approximately 1.0 patients/month to hit the enrollment target on schedule.

View on ClinicalTrials.gov

Ask AI

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Modification of the Neuropathic Pain Symptom Inventory for use in eye pain (NPSI-Eye).

Farhangi Monika, Feuer William, Galor Anat et al.Pain2020

DOI PubMed

PubMed/NCBI (daily updates) FDA FAERS (quarterly updates) WHO ICTRP (weekly updates)

Ask AI

Primary Outcomes

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

Change from baseline subjective ocular symptoms and symptom frequency via custom ocular pain questionnaire at 1 month

through treatment completion, 1 month

Number of patients with treatment-related adverse events as assessed by ocular pain questionnaire

through treatment completion, 1 month

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

Alternating and Direct Current Stimulation for Neuropathic Eye Pain

Enrollment & Timeline

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Alternating and Direct Current Stimulation for Neuropathic Eye Pain

Enrollment & Timeline

Multi-Source Intelligencefrom PubMed · FDA FAERS · WHO ICTRP

Primary Outcomes

Eligibility

Trial Sites (1)