Central Mechanisms of Calmare: an fMRI Trial

Completed · Not applicable

Conditions studied: Peripheral Neuropathy

In brief

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.

Key facts

Study ID

NCT04242797

Run by

Brigham Young University

People needed

39

Starts

2015-08-01

Expected to finish

2017-11-15

Last updated by the study team

2020-01-27

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• They must have suffered from a diagnosed peripheral neuropathy (diabetic, chemotherapy induced, or other) for a minimum of 6 months.
• At the time of the study they must experience pain greater than or equal to 5 on a visual analog pain scale from 0-10, with 0 being "no pain" and 10 being "the worst imaginable pain."

You may not qualify if…

• pregnancy
• a history of epilepsy or brain damage
• presence of a serious psychiatric disorder (e.g. schizophrenia, manic-depressive psychosis, primary major depression)
• multiple sources of chronic pain (e.g. a chronic pain condition other than a peripheral neuropathy or more than one site of neuropathies)
• a skin condition that would prevent application of skin electrodes
• latex allergy
• severe arrhythmia or any form of equivalent heart disease
• history of myocardial infarction or ischemic heart disease within the past 6 months
• celiac plexus block or other neurolytic pain control treatment within the past 4 weeks
• state of active withdrawal from drugs and/or alcohol
• ineligible for fMRI due to metal implants, etc.

Where it is running

• BYU MRI Research Facility — Provo, Utah, United States

Full record on ClinicalTrials.gov

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