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

Chronic Pain Clinical Trial

Official title:

Neural Correlates of Pain-related Cognitive Processing in Chronic Pain of the Cornea: an ERP and Electrical Stimulation Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575002
• Other study ID #: 2011-p-001902
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: September 2015

Study information

• Verified date: April 2020
• Source: Spaulding Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Corneal Pain
• Neuralgia
• Neuropathic Pain

Intervention

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.

Locations

Country	Name	City	State
United States	Spaulding Rehabilitation Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Measured for approximately 2 weeks
Secondary	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.	Measured for approximately 2 weeks