Effects of Transcranial Direct Current Stimulation (tDCS) in Chronic Corneal Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-09-30

Brief Summary

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In this study the investigators aim to examine the effects of Transcranial Direct Current Stimulation (tDCS) on pain levels as well as the changes in cognitive (thought) processing in individuals with chronic pain of the cornea -- and also compared with healthy controls.

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Detailed Description

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Conditions

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Corneal Pain Chronic Pain Neuropathic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active tDCS

Subjects will undergo 20 minutes of active tDCS stimulation.

Group Type EXPERIMENTAL

Transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

Subjects will undergo 2 sessions of 20 minutes of tDCS stimulation (either active or sham)in a randomized order - each session will be separated by at least one week to prevent carry-over effects.

Sham tDCS

Subjects will undergo 20 minutes of sham tDCS stimulation.

Group Type SHAM_COMPARATOR

Transcranial Direct Current Stimulation (tDCS)

Intervention Type DEVICE

Subjects will undergo 2 sessions of 20 minutes of tDCS stimulation (either active or sham)in a randomized order - each session will be separated by at least one week to prevent carry-over effects.

Interventions

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Transcranial Direct Current Stimulation (tDCS)

Subjects will undergo 2 sessions of 20 minutes of tDCS stimulation (either active or sham)in a randomized order - each session will be separated by at least one week to prevent carry-over effects.

Intervention Type DEVICE

Other Intervention Names

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1x1 direct current stimulator; Soterix Medical

Eligibility Criteria

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Inclusion Criteria

1. Provide informed consent to participate in the study;
2. 18 to 65 years old;

1. Corneal pain for six months or more;
2. Referral from a corneal specialist (Dr. Perry Rosenthal) with refractoriness to conventional ophthalmologic treatments for corneal pain such as local topical medications and soft bandage contact lenses;
3. Report a Visual Analogue Scale (VAS) for pain of 4 or greater in the previous 3 weeks;

Exclusion Criteria

1. History of alcohol or substance abuse within the last 6 months as self-reported;
2. Diagnosis of any neurological diseases (such as epilepsy);
3. Episodes of seizures within the last 6 months;
4. Unexplained loss of consciousness
5. Use of carbamazepine or neuropsychotropic drugs
6. Contraindications to tDCS

* Metal in the head
* Implanted brain medical devices
7. Pregnant at time of enrollment

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes