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

The University of Texas System (UT)

Status: Begins enrollment in 1 month

Conditions: Pain Management

Treatments: Device: Sham BreEStim Treatment; Device: Active BreEStim Treatment; Device: The TENS Treatment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07659743

HSC-MS-26-0102

UG3NS139014 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Enrollment: 66 estimated patients

Sex: All

Ages: 22 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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
• Able to tolerate BreEStim treatment for 1 minute

Exclusion criteria

• 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 baclofen pump or deep brain implants
• has 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 3 patient groups

Active BreEStim Treatment

Experimental group

Treatment:

Device: Active BreEStim Treatment

Sham BreEStim Treatment

Sham Comparator group

Treatment:

Device: Sham BreEStim Treatment

The transcutaneous electrical nerve stimulation (TENS) Treatment

Active Comparator group

Treatment:

Device: The TENS Treatment