Central Mechanisms of Calmare: an fMRI Trial

NCT04242797 | Completed FDA Device

• 1 other identifier: F15130
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

Peripheral Neuropathy

Keywords

Idiopathic; diabetic; chemotherapy-induced

Outcome Measures

Primary Outcomes (3)

• Visual Analaog Scale (VAS) Pain Score Changes

  Change from baseline in VAS score, which is marked on a line labeled 0 on the left (no pain) and 10 on the right (the most exquisite pain imaginable).

  The intra-subject change in VAS score from pre-Rx baseline a) after the 30-minute treatment and b) again the next day (pilot), or a) after each of the ten 30-minute treatments and b) 6- and 12-weeks from end of treatment (extended)

• Washington Neuropathic Pain Scale (WNPS) Pain Score Changes

  Change from baseline in each of ten WNPS scores, which are marked boxes have integral values of 0 on the left (no pain) and 10 on the right (the most exquisite pain imaginable).

  The intra-subject change in ten WNPS pain scores from baseline after the 30-minute Rx and again the next day (pilot) or after each of the ten 30-minute Rxs and 6- and 12-weeks from end of Rx period (extended)

• Changes in resting fMRI Correlations

  Change in temporal correlations of resting fMRI signals from 93 cerebral regions of interest.

  Intra-subject changes in fMRI signals from baseline (taken immediately before first Rx) obtained 30 minutes after first Rx (pilot) or 10th Rx (extended) and again 24 hours later (pilot) or 6-weeks later (extended).

Study Arms (2)

Calmare

ACTIVE COMPARATOR

Single- or ten-dose treatments on consecutive weekdays, 30 minutes each.

Device: Calmare

Traditional TENS

ACTIVE COMPARATOR

Single- or ten-dose treatments on consecutive weekdays, 30 minutes each.

Device: TENS

Interventions

Calmare DEVICE

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

Calmare

TENS DEVICE

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

Also known as: Traditional TENS

Traditional TENS

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Brigham Young University: lead
• Sorenson Legacy Foundation: collaborator
• Brigham Young University MRI Research Facility: collaborator

Study Sites (1)

BYU MRI Research Facility

Provo, Utah, 84602-1018, United States

Location

Related Publications (1)

• Majithia N, Smith TJ, Coyne PJ, Abdi S, Pachman DR, Lachance D, Shelerud R, Cheville A, Basford JR, Farley D, O'Neill C, Ruddy KJ, Sparadeo F, Beutler A, Loprinzi CL. Scrambler Therapy for the management of chronic pain. Support Care Cancer. 2016 Jun;24(6):2807-14. doi: 10.1007/s00520-016-3177-3. Epub 2016 Apr 4.

  PMID: 27041741 BACKGROUND

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• David D Busath, M.D.

  Brigham Young University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The investigator uses Bluetooth to control the output of a switching box for each patient from outside the treatment room. The box controls whether the inputs from the Calamare device or two traditional dual-channel TENS devices are connected to the output. The stimulus amplitude knobs for the TENS units are ganged to those of the Calmare using O-rings. When the therapist increases the stimulus amplitude on Calmare, that of the corresponding TENS unit is increased to about the same extent simultaneously.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Equal numbers of participants are randomly assigned to either the Calmare or traditional TENS group. Using skin electrodes positioned by the therapist proximal to the limb pain, each participant is given the assigned stimulation mode for 30-minute therapy sessions. One therapy is used in the pilot study and ten therapies on consecutive weekdays in the extended study.

Study Record Dates

• First Submitted: January 21, 2020
• First Posted: January 27, 2020
• Study Start: August 1, 2015
• Primary Completion: November 15, 2017
• Study Completion: November 15, 2017
• Last Updated: January 27, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)