BreEStim and tDCS for Neuropathic Pain Management - Healthy Subjects

The University of Texas Health Science Center, Houston6 enrolled

Overview

This study looks at the effect of combined breathing-controlled electrical stimulation (BreEStim) and transcranial direct current stimulation (tDCS) on neuropathic pain after spinal cord injury, amputation, or brain injury. The hypothesis is that a single session of combined BreEStim and tDCS will produce an additive analgesic effect. This record covers the study in a population of healthy volunteers. Note that this study will also enroll spinal cord injury patients, brain injury patients, and amputation patients and that this study as applied to these other populations will be covered in separate ClinicalTrials.gov records.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pain Management

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * between 18 and 75 years * male and female subjects * healthy subjects (i.e., no recent injuries or pain) Exclusion Criteria: * recent injuries or pain * have a pacemaker, or other metal and/or implanted devices * have amputation in their arm(s) * have spinal cord injury (SCI) involving impairment of arms * have cognitive impairment from brain injury or are not able to follow commands, or to give consent * have asthma or other pulmonary disease * are not medically stable * have preexisting psychiatric disorders * alcohol or drug abuse * have a history of seizures/Epilepsy, or taking benzodiazepines, anticonvulsants, and antidepressants. * Mini-mental state examination (MMSE), a brief 30-point questionnaire test that is commonly used in the literature, will be used to screen for cognitive impairment. A brain injury patient with a score of 24 or lower on MMSE will be excluded.

Outcomes

Primary Outcomes

Electrical Pain Threshold (EPT)

Electrical Pain Threshold (EPT) is a type of quantitative sensory test that assesses the lowest electrical current that first evokes a sensation of pricking pain.

Time frame: baseline, 10 minutes after tDCS, 10 minutes after BreEstim

Electrical Sensation Threshold (EST)

Electrical Detection Threshold (EDT) is a type of Quantitative sensory test that assesses the lowest electrical current that first evokes an electrical sensation.