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

NCT01575002 | Completed

• 1 other identifier: 2011-p-001902
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Corneal Pain; Chronic Pain; Neuropathic Pain

Keywords

transcranial stimulation; direct current stimulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in EEG measurements

  Measured for approximately 2 weeks

Study Arms (2)

Active tDCS

EXPERIMENTAL

Subjects will undergo 20 minutes of active tDCS stimulation.

Device: Transcranial Direct Current Stimulation (tDCS)

Sham tDCS

SHAM COMPARATOR

Subjects will undergo 20 minutes of sham tDCS stimulation.

Device: Transcranial Direct Current Stimulation (tDCS)

Interventions

Transcranial Direct Current Stimulation (tDCS) DEVICE

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.

Also known as: 1x1 direct current stimulator; Soterix Medical

Active tDCS; Sham tDCS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Provide informed consent to participate in the study;
• to 65 years old;
• 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;

You may not qualify if:

• 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

Sponsors & Collaborators

• Spaulding Rehabilitation Hospital: lead

Study Sites (1)

Spaulding Rehabilitation Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Chronic Pain; Neuralgia

Interventions

Transcranial Direct Current Stimulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques

Study Officials

• Felipe Fregni, MD PHD MPH

  Spaulding Rehabilitation Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 8, 2012
• First Posted: April 10, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

US (1)