Back to resultsEffects of Transcranial Direct Current Stimulation (tDCS) in Chronic Corneal Pain
Primary Purpose
Corneal Pain, Chronic Pain, Neuropathic Pain
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transcranial Direct Current Stimulation (tDCS)
Sponsored by
About this trial
This is an interventional basic science trial for Corneal Pain focused on measuring transcranial stimulation, direct current stimulation
Eligibility Criteria
Inclusion Criteria (for all subjects):
- Provide informed consent to participate in the study;
- 18 to 65 years old;
Additional Inclusion Criteria for Subjects with Chronic Corneal Pain:
- Corneal pain for six months or more;
- 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;
- Report a Visual Analogue Scale (VAS) for pain of 4 or greater in the previous 3 weeks;
Exclusion Criteria (for all subjects):
- History of alcohol or substance abuse within the last 6 months as self-reported;
- Diagnosis of any neurological diseases (such as epilepsy);
- Episodes of seizures within the last 6 months;
- Unexplained loss of consciousness
- Use of carbamazepine or neuropsychotropic drugs
Contraindications to tDCS
- Metal in the head
- Implanted brain medical devices
- Pregnant at time of enrollment
Sites / Locations
- Spaulding Rehabilitation Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active tDCS
Sham tDCS
Arm Description
Subjects will undergo 20 minutes of active tDCS stimulation.
Subjects will undergo 20 minutes of sham tDCS stimulation.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT01575002
First Posted
February 8, 2012
Last Updated
April 23, 2020
Sponsor
Spaulding Rehabilitation Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01575002
Brief Title
Effects of Transcranial Direct Current Stimulation (tDCS) in Chronic Corneal Pain
Official Title
Neural Correlates of Pain-related Cognitive Processing in Chronic Pain of the Cornea: an ERP and Electrical Stimulation Study.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
September 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Spaulding Rehabilitation Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corneal Pain, Chronic Pain, Neuropathic Pain
Keywords
transcranial stimulation, direct current stimulation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active tDCS
Arm Type
Experimental
Arm Description
Subjects will undergo 20 minutes of active tDCS stimulation.
Arm Title
Sham tDCS
Arm Type
Sham Comparator
Arm Description
Subjects will undergo 20 minutes of sham tDCS stimulation.
Intervention Type
Device
Intervention Name(s)
Transcranial Direct Current Stimulation (tDCS)
Other Intervention Name(s)
1x1 direct current stimulator; Soterix Medical
Intervention Description
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 Outcome Measure Information:
Title
Changes in pain scales
Description
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 Outcome Measure Information:
Title
Changes in EEG measurements
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria (for all subjects):
Provide informed consent to participate in the study;
18 to 65 years old;
Additional Inclusion Criteria for Subjects with Chronic Corneal Pain:
Corneal pain for six months or more;
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;
Report a Visual Analogue Scale (VAS) for pain of 4 or greater in the previous 3 weeks;
Exclusion Criteria (for all subjects):
History of alcohol or substance abuse within the last 6 months as self-reported;
Diagnosis of any neurological diseases (such as epilepsy);
Episodes of seizures within the last 6 months;
Unexplained loss of consciousness
Use of carbamazepine or neuropsychotropic drugs
Contraindications to tDCS
Metal in the head
Implanted brain medical devices
Pregnant at time of enrollment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Felipe Fregni, MD PHD MPH
Organizational Affiliation
Spaulding Rehabilitation Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spaulding Rehabilitation Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Effects of Transcranial Direct Current Stimulation (tDCS) in Chronic Corneal Pain
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