Central Mechanisms of Calmare: an fMRI Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-01

Study Completion Date

2017-11-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

A Clinical Trial of Mirror Treatment for Phantom Pain

NCT02912975

Phantom Limb Pain Complex Regional Pain Syndromes

COMPLETED NA

Conditioning Electrical Stimulation to Improve Outcomes in Cubital Tunnel Syndrome

NCT05395715

Cubital Tunnel Syndrome Electrical Stimulation

RECRUITING NA

Electrical Stimulation to Enhance Peripheral Nerve Regeneration

NCT02403661

Peripheral Nerve Injuries

RECRUITING NA

Trial of Self-managed Approaches for Patellofemoral Pain Syndrome in Active Duty

NCT02597673

Patellofemoral Pain Syndrome

COMPLETED NA

Functional Magnetic Stimulation (FMS) for Bone Marrow Edema in Athletes

NCT07234084

Bone Marrow Edema

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peripheral Neuropathy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Calmare

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

Group Type ACTIVE_COMPARATOR

Calmare

Intervention Type DEVICE

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

Traditional TENS

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

Group Type ACTIVE_COMPARATOR

TENS

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Calmare

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

Intervention Type DEVICE

TENS

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Traditional TENS

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No