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

Official title

A Randomized, Double-blind, Sham-controlled, Parallel-group Trial Designed to Evaluate the Efficacy of BreEStim in Managing Neuropathic Pain After Spinal Cord Injury (SCI)

Overview

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).

Interventions

• Device Active BreEStim Treatment
  During the Active 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. Electrical stimulation will be synchronized with voluntary breathing and delivered at an individually tolerated intensity for approximately 30 minutes.
• Device Sham BreEStim Treatment
  During the Sham 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. Electrical stimulation will be synchronized with voluntary breathing and delivered at the sensory threshold level for approximately 30 minutes.
• Device The TENS Treatment
  During the TENS Treatment session, participants will remain relaxed while transcutaneous electrical stimulation is applied through surface electrodes placed over the painful area. Stimulation will be delivered at an individually tolerated intensity for approximately 30 minutes.

Primary outcome measures

• Change in Pain Level as Measured by the Visual Analog Scale (VAS). [Time frame: Baseline, 10-15 minutes after intervention]

Secondary outcome measures (2)

• the difference in the percentage of responders between active BreEStim and Sham BreEStim groups [Time frame: Baseline, 10-15 minutes after intervention]
• the difference in the percentage of responders between between active BreEStim and transcutaneous electrical nerve stimulation (TENS) groups. [Time frame: Baseline, 10-15 minutes after intervention]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Treatment

Study locations

United States · 1 center

• The University of Texas Health Science Center at Houston — Houston

Identifiers

NCT: NCT07659743 · HSC-MS-26-0102 · UG3NS139014

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗