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Central Mechanisms of Calmare: an fMRI Trial

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ClinicalTrials.gov Identifier: NCT04242797
Recruitment Status : Completed
First Posted : January 27, 2020
Last Update Posted : January 27, 2020
Sponsor:
Collaborators:
Sorenson Legacy Foundation
Brigham Young University MRI Research Facility
Information provided by (Responsible Party):
David D Busath, Brigham Young University

Tracking Information
First Submitted Date  ICMJE January 21, 2020
First Posted Date  ICMJE January 27, 2020
Last Update Posted Date January 27, 2020
Actual Study Start Date  ICMJE August 1, 2015
Actual Primary Completion Date November 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 23, 2020)
  • Visual Analaog Scale (VAS) Pain Score Changes [ Time Frame: 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) ]
    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).
  • Washington Neuropathic Pain Scale (WNPS) Pain Score Changes [ Time Frame: 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) ]
    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).
  • Changes in resting fMRI Correlations [ Time Frame: 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). ]
    Change in temporal correlations of resting fMRI signals from 93 cerebral regions of interest.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Central Mechanisms of Calmare: an fMRI Trial
Official Title  ICMJE Central Mechanisms of Calmare: an fMRI Trial
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.
Detailed Description

Pain can be either useful or harmful. Acute pain conveys information to the brain about real or potential damage that can productively lead to avoidance or treatment of the damage. However, chronic pain, which extends beyond these useful purposes, becomes a potentially debilitating inconvenience. Estimations based on surveys report that as many as 33% of Americans suffer from chronic pain, with a significant portion being unable to successfully manage it.

The current means to treating chronic pain include: surgery, drug therapy, physical therapy, psychological intervention, and others. Unfortunately, despite these options, many people continue to suffer from a chronic pain condition. Neuropathic pain, or pain caused by nervous system damage, is particularly hard to treat. Drug therapy and surgery have relatively low success rates and undesirable side effects. Thus, there is a need for additional research and new treatment methods for neuropathic pain patients.

The Calmare device was designed as one such means to treat chronic neuropathic pain. It works through electrostimulation of the skin near the pain site, and, according to recent studies, has significantly reduced chronic neuropathic pain in most subjects (Majithia et al., 2016).

Previous studies of Calmare effectiveness have defined the success of treatment as the reduction of reported pain levels by the patient. Though useful, these studies fail to provide an objective measurement of pain reduction and fail to discover the mechanisms by which it occurs. In addition, previous studies have been unable to perform a true double-blind experiment in which the placebo effect was entirely accounted for. The pilot study takes a step toward filling this gap by performing a double blind, randomized single-treatment trial comparing Calmare efficacy to traditional transcutaneous electrical nerve stimulation (TENS) efficacy. The ten-treatment study examines the durability of the pain relief for 12 weeks after the treatment period.

The goal of these studies is two-fold: first, to use fMRI before and after a full therapeutic Calmare treatment course to determine the extent to which Calmare affects the connectivity of the pain centers of the brain, and second, to determine whether traditional TENS or Calmare is more effective in reducing neuropathic chronic pain. The Calmare treatment is administered in a double-blind fashion with neither the technician, nor the subject knowing whether the TENS or the Calmare is being administered. The investigator's hypothesis is that Calmare therapy decreases subject pain through a central mechanism that will be manifest in decreased functional connectivity of the brain's pain centers. The degree to which this happens is determined by comparing the decrease in pain intensity, as reported by the patient, with the difference in fMRI BOLD temporal correlations between pain centers.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
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.
Masking: Double (Participant, Care Provider)
Masking Description:
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.
Primary Purpose: Treatment
Condition  ICMJE Peripheral Neuropathy
Intervention  ICMJE
  • 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.
    Other Name: Traditional TENS
Study Arms  ICMJE
  • Active Comparator: Calmare
    Single- or ten-dose treatments on consecutive weekdays, 30 minutes each.
    Intervention: Device: Calmare
  • Active Comparator: Traditional TENS
    Single- or ten-dose treatments on consecutive weekdays, 30 minutes each.
    Intervention: Device: TENS
Publications * 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 23, 2020)
39
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 15, 2017
Actual Primary Completion Date November 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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."

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04242797
Other Study ID Numbers  ICMJE F15130
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party David D Busath, Brigham Young University
Study Sponsor  ICMJE Brigham Young University
Collaborators  ICMJE
  • Sorenson Legacy Foundation
  • Brigham Young University MRI Research Facility
Investigators  ICMJE
Principal Investigator: David D Busath, M.D. Brigham Young University
PRS Account Brigham Young University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP