Overview

This trial is active, not recruiting.

Conditions corneal pain, chronic pain, neuropathic pain
Treatment transcranial direct current stimulation (tdcs)
Phase phase 1
Sponsor Spaulding Rehabilitation Hospital
Start date January 2012
End date January 2017
Trial size 70 participants
Trial identifier NCT01575002, 2011-p-001902

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, outcomes assessor)
Primary purpose basic science
Arm
(Experimental)
Subjects will undergo 20 minutes of active tDCS stimulation.
transcranial direct current stimulation (tdcs) 1x1 direct current stimulator; Soterix Medical
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 Comparator)
Subjects will undergo 20 minutes of sham tDCS stimulation.
transcranial direct current stimulation (tdcs) 1x1 direct current stimulator; Soterix Medical
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.

Primary Outcomes

Measure
Changes in pain scales
time frame: Measured for approximately 2 weeks

Secondary Outcomes

Measure
Changes in EEG measurements
time frame: Measured for approximately 2 weeks

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title Neural Correlates of Pain-related Cognitive Processing in Chronic Pain of the Cornea: an ERP and Electrical Stimulation Study.
Principal investigator Felipe Fregni, MD PHD MPH
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Spaulding Rehabilitation Hospital.