BreEStim for Neuropathic Pain

SL
SL
Overseen ByShengai Li, MS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: The University of Texas Health Science Center, Houston
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for managing neuropathic pain, which arises from nerve damage after a spinal cord injury. Researchers compare three treatments: Breathing Controlled Electrical Stimulation (BreEStim), a sham version of BreEStim, and Transcutaneous Electrical Nerve Stimulation (TENS). Individuals who have had a spinal cord injury for over a year and continue to experience neuropathic pain despite medication may be suitable candidates. The study aims to determine which treatment most effectively reduces pain. As an unphased trial, it offers patients the chance to contribute to innovative research that could lead to new pain management solutions.

What prior data suggests that BreEStim is safe for managing neuropathic pain?

A previous study found Breathing Controlled Electrical Stimulation (BreEStim) to be safe and effective for managing long-term nerve pain in people with spinal cord injuries. This treatment uses electrical pulses synchronized with the patient's breathing, set at a comfortable level. Research shows that BreEStim does not cause significant negative side effects.

For Transcutaneous Electrical Nerve Stimulation (TENS), moderate-certainty evidence indicates it can lower pain levels without causing serious side effects. Used since the 1960s, TENS is generally well tolerated, although its success can depend on correct electrode placement on the body.

Both treatments are considered safe, with no major negative events reported in studies.12345

Why are researchers excited about this trial?

Breathing Controlled Electrical Stimulation (BreEStim) is unique because it combines controlled breathing with electrical stimulation to target neuropathic pain. Unlike conventional treatments like medications or standard Transcutaneous Electrical Nerve Stimulation (TENS), BreEStim synchronizes breathing with electrical impulses, potentially enhancing pain relief through a novel mechanism. Researchers are excited because this approach could offer more personalized and effective pain management, reducing reliance on drugs and their side effects. Meanwhile, the Sham BreEStim serves as a control to assess the genuine impact of the active treatment, and TENS is used as a comparison to evaluate the effectiveness of BreEStim against a well-known standard.

What evidence suggests that this trial's treatments could be effective for neuropathic pain after spinal cord injury?

This trial will compare treatments for neuropathic pain, including Breathing Controlled Electrical Stimulation (BreEStim) and Transcutaneous Electrical Nerve Stimulation (TENS). Research has shown that BreEStim, which participants in this trial may receive, could effectively treat long-lasting nerve pain, particularly in individuals with spinal cord injuries. Studies indicate that BreEStim can significantly increase pain tolerance by using electrical pulses that align with breathing patterns, potentially altering the brain's perception of pain.

In contrast, TENS, another treatment option in this trial, has shown mixed results. Some studies suggest TENS might reduce pain levels, especially during and immediately after treatment. However, other research struggles to demonstrate that TENS is more effective than a placebo. Overall, BreEStim appears more consistently promising for managing nerve pain in this context.23678

Who Is on the Research Team?

SL

Sheng Li, MD, PhD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for people who have nerve pain after a spinal cord injury. Participants should be adults with ongoing neuropathic pain related to their injury. People with other major health issues or conditions that could interfere with the study may not be able to join.

Inclusion Criteria

I have had nerve pain for more than 3 months.
Has a history of SCI greater than 1 year
I have been taking the same oral pain medication for at least one month.
See 2 more

Exclusion Criteria

I have nerve damage that does not respond to electrical stimulation.
Has severe mental disorders (e.g., depression, substance abuse) and is receiving active treatment and frequent monitoring
Is on a mechanical ventilator
See 10 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive BreEStim, sham BreEStim, or TENS to manage neuropathic pain after spinal cord injury

10-15 minutes per session
Multiple sessions over a period of weeks

Follow-up

Participants are monitored for changes in pain levels using the Visual Analog Scale (VAS)

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Breathing Controlled Electrical Stimulation (BreEStim)
  • Sham BreEStim Treatment
  • Transcutaneous Electrical Nerve Stimulation (TENS)

Trial Overview

The study compares three treatments for nerve pain: BreEStim (breathing-controlled electrical stimulation), a fake version of BreEStim (sham), and standard TENS therapy. Participants are randomly assigned to one of these groups.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Active Control

Placebo Group

Group I: Active BreEStim TreatmentExperimental Treatment1 Intervention
Group II: The transcutaneous electrical nerve stimulation (TENS) TreatmentActive Control1 Intervention
Group III: Sham BreEStim TreatmentPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials
974
Recruited
361,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

National Institute of Neurological Disorders and Stroke (NINDS)

Collaborator

Trials
1,403
Recruited
655,000+

Citations

Breathing-Controlled Electrical Stimulation (BreEStim) ...

The present study used EEG to examine BreEStim's neural effects on sensory, affective, and cognitive components of pain. Fourteen healthy participants (7 M, 7 F) ...

Journal of Rehabilitation Medicine

Bre-Estim has an immediate analgesic effect in comparison with active tDCS. there was no additive effect of a combined tDCS and BreEstim intervention for ...

breathing-controlled electrical stimulation for neuropathic pain ...

These findings in this preliminary study suggest that BreEStim is an effective alternative nonpharmacological treatment for chronic neuropathic pain in patients ...

Pain modulation effect of breathing-controlled electrical ...

Results showed no change in electrical pain threshold after Breathing-only, but a significant increase in electrical pain threshold after ...

BreEStim in Managing Neuropathic Pain After Spinal Cord ...

The purpose of this study is to compare the effectiveness of innovative intervention of breathing controlled electrical stimulation (BreEStim)

Breathing-controlled Electrical Stimulation (BreEStim) for ...

TENS is noninvasive, inexpensive, safe and easy to use18. The possible side effects include addiction, overdose, withdrawal symptoms, and ...

Modification of Electrical Pain Threshold by Voluntary ...

Breathing-controlled electrical stimulation (BreEStim) could modify the affective component of neuropathic pain after amputation: a case report.

Breathing-Control Electrical Stimulation

This study presents BreEStim, a novel method for managing neuropathic pain and spasticity through synchronized electrical stimulation with ...