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

Spaulding Rehabilitation Hospital26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Corneal Pain Chronic Pain Neuropathic Pain

Interventions

Transcranial Direct Current Stimulation (tDCS)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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria (for all subjects): 1. Provide informed consent to participate in the study; 2. 18 to 65 years old; Additional Inclusion Criteria for Subjects with Chronic Corneal Pain: 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 (for all subjects): 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

Locations (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

Changes in pain scales

We will measure changes in the visual analogue scale (VAS) for pain, and also measure pain threshold (using an algometer) before and after each stimulation session. We will compare the measurements from before stimulation to after stimulation, in each scheduled session, as this study is measuring the effects of a single session of tDCS.

Time frame: Measured for approximately 2 weeks

Secondary Outcomes

Changes in EEG measurements

We will measure changes in event related potentials (ex. P300, mismatch negativity) recorded via electroencephalography (EEG) before and after each stimulation session. We will compare the measurements from before stimulation to after stimulation, in each scheduled session, as this study is measuring the effects of a single session of tDCS.

Time frame: Measured for approximately 2 weeks

Data from ClinicalTrials.gov

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