BreEStim and tDCS for Neuropathic Pain Management - Healthy Subjects

Study Overview
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Brief Summary
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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.

Official Title
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Combined Peripheral (BreEStim) and Central Electrical Stimulation (tDCS) for Neuropathic Pain Management

Conditions
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Pain Management

Intervention / Treatment
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* Device: BreEStim
* Device: tDCS active
* Device: tDCS sham


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sham tDCS and BreEStim<br>This arm includes a 20-min sham tDCS to the current dominant primary motor cortex (M1), followed by a 20-min BreEStim to the median nerve (160 times) transcutaneously on the current dominant side. | Device: BreEStim<br>* BreEStim will applied for 10 to 20 minutes.<br>Device: tDCS sham<br> <br> |
| Experimental: active tDCS (M1) and BreEStim<br>This arm includes a 20-min active tDCS to the current dominant primary motor cortex (M1), followed by a 20-min BreEStim to the median nerve (160 times) transcutaneously on the current dominant side. | Device: BreEStim<br>* BreEStim will applied for 10 to 20 minutes.<br>Device: tDCS active<br>* tDCS will be applied for 20 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | baseline, 10 minutes after tDCS, 10 minutes after BreEstim |