BreEStim Pre-trial

• Single-pulse BreEStim Treatment (Device): During the Single-pulse BreEStim Treatment session, participants will remain relaxed while breathing is monitored using a nasal cannula. Surface electrodes will be placed over the median nerve at the wrist or another selected peripheral nerve. A single-pulse electrical stimulation will be synchronized with voluntary breathing and delivered at an individually tolerated intensity for approximately 30 minutes.
• Multiple-pulse BreEStim Treatment (Device): During the Multiple-pulse BreEStim Treatment session, participants will remain relaxed while breathing is monitored using a nasal cannula. Surface electrodes will be placed over the median nerve at the wrist or another selected peripheral nerve. Multiple-pulse electrical stimulation will be synchronized with voluntary breathing and delivered at an individually tolerated intensity for approximately 30 minutes.

Primary outcomes

• Change in Pain Level as Measured by the Visual Analog Scale (VAS). [Baseline, 10-15 minutes after intervention]: VAS scores are recorded from 0 to 10 with 0 being "no pain" and 10 being "worst pain", a higher score indicating a higher level of pain. Change is reported as \[(VAS score at baseline) - (VAS Score 10 minutes after intervention)\] - a positive value indicates that the score (and pain level) decreased. Mean VAS difference will be compared.

Sex: All, ages: 18 Years to 75 Years, accepts healthy volunteers

Inclusion Criteria (SCI subjects):

* has a history of SCI > 1 year;
* has a DN4 (Douleur Neuropathique en 4 questions)* score of 4 or greater;
* has an average pain score of 4 or more
* has neuropathic pain >3 months;
* is between 22 to 80 years of age;
* is stable on oral pain medications at least one month (no change in frequency and dosing of pain medications);
* is able to tolerate BreEStim treatment for 1 minute.

Exclusion Criteria (SCI subjects):

* is on a mechanical ventilator;
* is currently having active urinary tract infection (UTI);
* does not have any residual sensation in the arms;
* has other pain (musculoskeletal, visceral etc.), but not neuropathic, e.g., shoulder pain from wheelchair use;
* has a pacemaker (to avoid possible side effect of electrical stimulation);
* is not able to follow commands, or to give consent;
* has asthma or other pulmonary disease;
* has a history of cardiac pathology, implanted pacemakers, or current use of rhythm altering medication like beta-blockers;
* has a baclofen pump or deep brain implants;
* has a respiratory tract/sinus infection and rhinorrhea;
* has low motor neuron injury that no responses will be triggered by electrical stimulation;
* has severe mental disorders (e.g., depression, substance abuse) and is receiving active treatment and frequent monitoring;
* is not medically stable.
* Pregnancy

Inclusion criteria (healthy subjects):

* healthy;
* between 18-75 years old.

Exclusion criteria (healthy subjects):

* individuals with neuromusculoskeletal impairments/injury or pain;
* women who are pregnant

• Sheng Li, MD, PhD, Principal investigator, The University of Texas Health Science Center, Houston

NIH grants: UG3NS139014