Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01575002
Recruitment Status : Completed
First Posted : April 10, 2012
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital

Tracking Information
First Submitted Date  ICMJE February 8, 2012
First Posted Date  ICMJE April 10, 2012
Last Update Posted Date April 24, 2020
Study Start Date  ICMJE January 2012
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
Changes in pain scales [ Time Frame: Measured for approximately 2 weeks ]
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2012)
Changes in EEG measurements [ Time Frame: Measured for approximately 2 weeks ]
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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Transcranial Direct Current Stimulation (tDCS) in Chronic Corneal Pain
Official Title  ICMJE Neural Correlates of Pain-related Cognitive Processing in Chronic Pain of the Cornea: an ERP and Electrical Stimulation Study.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Corneal Pain
  • Chronic Pain
  • Neuropathic Pain
Intervention  ICMJE Device: 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.
Other Name: 1x1 direct current stimulator; Soterix Medical
Study Arms  ICMJE
  • Experimental: Active tDCS
    Subjects will undergo 20 minutes of active tDCS stimulation.
    Intervention: Device: Transcranial Direct Current Stimulation (tDCS)
  • Sham Comparator: Sham tDCS
    Subjects will undergo 20 minutes of sham tDCS stimulation.
    Intervention: Device: Transcranial Direct Current Stimulation (tDCS)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 17, 2017)
26
Original Estimated Enrollment  ICMJE
 (submitted: April 9, 2012)
70
Actual Study Completion Date  ICMJE September 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01575002
Other Study ID Numbers  ICMJE 2011-p-001902
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Felipe Fregni, Spaulding Rehabilitation Hospital
Study Sponsor  ICMJE Spaulding Rehabilitation Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Felipe Fregni, MD PHD MPH Spaulding Rehabilitation Hospital
PRS Account Spaulding Rehabilitation Hospital
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP