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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Spaulding Rehabilitation Hospital
Sponsor:
Information provided by (Responsible Party):
Felipe Fregni, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier:
NCT01575002
First received: February 8, 2012
Last updated: September 29, 2014
Last verified: September 2014

February 8, 2012
September 29, 2014
January 2012
January 2015   (final data collection date for primary outcome measure)
Changes in pain scales [ Time Frame: Measured for approximately 2 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01575002 on ClinicalTrials.gov Archive Site
Changes in EEG measurements [ Time Frame: Measured for approximately 2 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Not Provided
Not Provided
 
Effects of Transcranial Direct Current Stimulation (tDCS) in Chronic Corneal Pain
Neural Correlates of Pain-related Cognitive Processing in Chronic Pain of the Cornea: an ERP and Electrical Stimulation Study.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
  • Corneal Pain
  • Chronic Pain
  • Neuropathic Pain
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
  • 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)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
Not Provided
January 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
Yes
Contact: Felipe Fregni, MD PhD MPH 617-573-2326 ffregni@partners.org
Contact: Kayleen M Weaver, BA 617-573-2196 kmweaver@partners.org
United States
 
NCT01575002
2011-p-001902
No
Felipe Fregni, Spaulding Rehabilitation Hospital
Spaulding Rehabilitation Hospital
Not Provided
Principal Investigator: Felipe Fregni, MD PHD MPH Spaulding Rehabilitation Hospital
Spaulding Rehabilitation Hospital
September 2014

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