BreEStim 120 for Pain Management

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Pain ManagementBreEStim 120 - Device
Eligibility
18 - 75
All Sexes
What conditions do you have?
Select

Study Summary

This trial will compare two electrical stimulation treatments for phantom limb pain in amputees.

Eligible Conditions
  • Pain Management

Treatment Effectiveness

Study Objectives

4 Primary · 0 Secondary · Reporting Duration: Baseline, 5 minutes after intervention

Baseline, 5 minutes after intervention
Change in Heart Rate Variability (HRV) measured by electrocardiogram (ECG)
Change in Pain as measured by the visual analog scale (VAS). Scores are recorded from 0 to10.
Change in pain measured by Electrical pain detection threshold (EPT)
Change in sensation measured by Electrical sensation detection threshold (EDT)

Trial Safety

Trial Design

2 Treatment Groups

BreEStim 240, then BreEStim 120
1 of 2
BreEStim 120, then BreEStim 240
1 of 2

Experimental Treatment

16 Total Participants · 2 Treatment Groups

Primary Treatment: BreEStim 120 · No Placebo Group · N/A

BreEStim 240, then BreEStim 120Experimental Group · 2 Interventions: BreEStim 240, BreEStim 120 · Intervention Types: Device, Device
BreEStim 120, then BreEStim 240Experimental Group · 2 Interventions: BreEStim 240, BreEStim 120 · Intervention Types: Device, Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 5 minutes after intervention

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
811 Previous Clinical Trials
256,241 Total Patients Enrolled
4 Trials studying Pain Management
56 Patients Enrolled for Pain Management
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
56 Previous Clinical Trials
6,912 Total Patients Enrolled
2 Trials studying Pain Management
38 Patients Enrolled for Pain Management
Sheng Li, MD, PhD4.896 ReviewsPrincipal Investigator - The University of Texas Health Science Center, Houston
Swedish Medical Center / First Hill Campus, Swedish Medical Center / Cherry Hill Campus, Swedish Medical Center / Issaquah Campus
Medical School - Rosalind Franklin University of Medicine and Science, Doctor of Medicine
Louisiana State University, Residency in Ophthalmology
8 Previous Clinical Trials
85 Total Patients Enrolled
4 Trials studying Pain Management
56 Patients Enrolled for Pain Management
4Patient Review
I appreciated the time taken to examine my eyes in detail. The doctor and his associate were both very professional.

Eligibility Criteria

Age 18 - 75 · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have phantom limb pain (PLP) after amputation of one limb, upper or lower limb.
You have chronic pain, >3 months.