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NCT07878429
BreEStim Pre-trial
Conditions: Neuropathic Pain
Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 32
Sponsor: The University of Texas Health Science Center, Houston
Location: The University of Texas Health Science Center at Houston Houston Texas
Summary
The overall goal is to evaluate the effectiveness of different stimulation protocol of a novel intervention - Breathing-controlled electrical stimulation (BreEStim) in managing neuropathic pain after spinal cord injury (SCI).
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07878429). StuddyBuddy aggregates publicly available trial information.