BreEStim 240 for Pain Management

The University of Texas Health Science Center, Houston, TX
Pain ManagementBreEStim 240 - Device
Eligibility
18 - 75
All Sexes

Study Summary

This trial compares two electrical stimulation treatments for neuropathic phantom limb pain.

Eligible Conditions
  • Pain Management

Treatment Effectiveness

Phase-Based Effectiveness

1 of 3
N/A

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Study Objectives

4 Primary · 0 Secondary · Reporting Duration: Baseline, after 10 intervention sessions, about 2 weeks

Week 2
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

Phase-Based Safety

1 of 3

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Awards & Highlights

No Placebo Group
All patients enrolled in this trial will receive the new treatment.

Trial Design

2 Treatment Groups

BreEStim
1 of 2
EStim
1 of 2

Experimental Treatment

24 Total Participants · 2 Treatment Groups

Primary Treatment: BreEStim 240 · No Placebo Group · N/A

BreEStim
Device
Experimental Group · 1 Intervention: BreEStim 240 · Intervention Types: Device
EStim
Device
Experimental Group · 1 Intervention: EStim 240 · Intervention Types: Device

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, after 10 intervention sessions, about 2 weeks

Who is running the clinical trial?

The University of Texas Health Science Center, HoustonLead Sponsor
836 Previous Clinical Trials
264,017 Total Patients Enrolled
4 Trials studying Pain Management
48 Patients Enrolled for Pain Management
National Institute on Disability, Independent Living, and Rehabilitation ResearchFED
58 Previous Clinical Trials
7,059 Total Patients Enrolled
2 Trials studying Pain Management
30 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
77 Total Patients Enrolled
4 Trials studying Pain Management
48 Patients Enrolled for Pain Management
4Patient Review
I appreciated the thoroughness of the doctor and his associate during my examination.

Eligibility Criteria

Age 18 - 75 · All Participants · 2 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You experience pain in a limb that has been amputated.
You have been experiencing long-lasting pain for more than 3 months.
References

Frequently Asked Questions

Does this clinical investigation accept participants who are aged 65 or more?

"As per the outlined parameters for inclusion, individuals aged 18 or above but no older than 75 can take part in this study." - Anonymous Online Contributor

Unverified Answer

How many individuals are engaged in this research endeavor?

"Verified. Clinicaltrials.gov provides evidence that recruitment for this medical research has been underway since April 2nd 2021, and was last modified on May 21st of the same year. The experiment seeks to enlist 24 patients from a single site." - Anonymous Online Contributor

Unverified Answer

Is enrollment still open for this research endeavor?

"Based on the listings available through clinicaltrials.gov, this study is still recruiting participants. It was originally posted on April 2nd 2021 and the listing has been recently updated as of May 21st 2021." - Anonymous Online Contributor

Unverified Answer

Am I eligible to take part in this experimental research?

"To be eligible for this medical trial, patients must fulfill the following criteria: ages 18 to 75; currently suffering from [chronic pain](https://www.withpower.com/clinical-trials/chronic-pain) (>3 months); have phantom limb pain (PLP) after amputation of one limb, upper or lower; and remain stable on their current oral pain medications for two weeks." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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