BreEStim in Managing Neuropathic Pain After Spinal Cord Injury (SCI)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorThe University of Texas Health Science Center, Houston

About this trial

The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim) and sham BreEStim and Transcutaneous Electrical Nerve Stimulation (TENS) in management of neuropathic pain in patients after spinal cord injury (SCI).

Eligibility criteria

Qualifiers

has a history of SCI > 1 year

has a DN4 (Douleur Neuropathique en 4 Questions) score of 4 or greater

has neuropathic pain >3 months

is stable on oral pain medications at least one month

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Active BreEStim Treatment
  • Sham BreEStim Treatment
  • The TENS Treatment

Treatment groups

66 Participants
are divided into 3 treatment groups

Sponsors and collaborators

The University of Texas Health Science Center, Houston

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator