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Central Mechanisms of Calmare: an fMRI Trial

NCT04242797 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 39

Last updated 2020-01-27

No results posted yet for this study

Summary

Pilot one-treatment and extended 10-treatment studies are carried out on participants with peripheral neuropathy comparing traditional TENS and Calmare stimulation protocols using a double-blind apparatus. Resting fMRI scans are obtained before and after the treatment, as well as after most of the pain has returned.

Conditions

Interventions

DEVICE

Calmare

Skin is stimulated with an electrical voltage via electrode pads, variably distorted sine wave at \~47 Hz.

DEVICE

TENS

Skin is stimulated with an electrical voltage via electrode pads, 300 micro-second rectangle pulse at 47 Hz.

Sponsors & Collaborators

  • Sorenson Legacy Foundation

    collaborator UNKNOWN

  • Brigham Young University MRI Research Facility

    collaborator UNKNOWN

  • Brigham Young University

    lead OTHER

Principal Investigators

  • David D Busath, M.D. · Brigham Young University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-08-01
Primary Completion
2017-11-15
Completion
2017-11-15
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04242797 on ClinicalTrials.gov