Calmer Canine® Research

Randomized, Placebo-Controlled Prospective Clinical Trial Evaluating the Efficacy of the Assisi Anti-anxiety Device (Calmer Canine) for the Treatment of Canine Separation Anxiety

A placebo-controlled, double-blind study testing the efficacy of Calmer Canine on dogs was completed at North Carolina State University in December 2021. Building off Assisi’s 2019 pilot study, this revolutionary study confirms that Calmer Canine is an effective solution to canine separation anxiety (SA), proven to provide long-term relief for anxious dogs.

Study Synopsis

Forty client-owned dogs with moderate to severe separation anxiety completed the placebo-controlled double-blind study. Half of the dogs were treated with an active tPEMF (Calmer Canine) device placed over the dog’s head twice daily for 15 minutes, while half of the dogs received a placebo therapy device. All dogs were treated for six weeks.

Dogs with concomitant thunder/noise phobia and dogs on multiple SA medications were excluded from the study.

Data Collection

Video data is essential to the diagnosis of SA in dogs since it is objective and unbiased whereas owner survey data tends to have a high caregiver/placebo effect. The Calmer Canine Study is the first of its kind to use video data to demonstrate the independent efficacy of a non-pharmaceutical device (i.e., Calmer Canine) – prior pharmaceutical and non-pharmaceutical studies relied only on owner survey data.

Study Results

After just one week of Calmer Canine treatments, 50% of owners documented improvement. After four weeks, almost two-thirds of dogs had a 100% or greater improvement in the time they spent relaxing when left alone. By the end of six weeks, results showed that Calmer Canine:

  • Significantly reduces signs of separation anxiety, resulting in a six-fold greater improvement in passive behaviors compared to dogs treated with a placebo device
  • Increases positive, non-anxious behaviors, resulting in reported levels of anxiety similar to the normal range for dogs not suffering from SA
  • Is safe and well-tolerated, even when combined with psychotherapeutic medication
  • Half of participants noticed results in first week

View the complete abstract for this study

Randomized, Placebo-Controlled Prospective Study Evaluating the Efficacy of the Assisi Anti-anxiety Device (Calmer Canine) for the Treatment of Canine Separation Anxiety

Katherine Pankratz1, Judy Korman2, Carrie Emke3, Brianna Johnson3, Emily H. Griffith4 and Margaret E. Gruen1,5*

1Behavioral Medicine Service, Department of Clinical Sciences, College of Veterinary Medicine, North Carolina State University, Raleigh, NC, United States

2Assisi Animal Health, Northvale, NJ, United States

3Clinical Studies Core, Department of Clinical Sciences, College of Veterinary Medicine, North Carolina State University, Raleigh, NC, United States

4Department of Statistics, College of Sciences, North Carolina State University, Raleigh, NC, United States

5Comparative Behavioral Research, Department of Clinical Sciences, College of Veterinary Medicine, North Carolina State University, Raleigh, NC, United States

Treatment of Canine Separation Anxiety Using a Pulsed Electromagnetic Field Device: A Pilot Study

Canine separation anxiety is a common disorder in dogs and affects an estimated 14-17% of the pet dog population in the United States. Separation anxiety is associated with significant distress to both dogs and owners, with dogs showing a variety of clinical signs including hypersalivation, destruction of property, excessive vocalization, and self-injurious behavior when left alone. While pharmacologic treatments are available, these may not be indicated for every case, and a safe, non-pharmacologic treatment is needed. Treatment with pulsed electromagnetic fields (PEMFs) has been used in the management of mood disorders in humans and has the potential to modulate anxiety in dogs. In this pilot open trial study, nine dogs with separation anxiety were treated with a PEMF device placed on the head twice daily for 15 minutes, for six weeks.

Owners completed questionnaires on Days 0, 7, 14, 28, and 42, and took videos of their dogs while home alone on Days 0, 28, and 42. On Days 28 and 42, all nine dogs had a reduction in overall anxiety scores (Wald score interval = 0.66 – 1.00 for each), with five showing resolution of clinical signs on Day 42 (95% CI = 0.21 – 0.85). Videos were coded for positive and negative behaviors, and results from Days 28 and 42 were compared to Day 0. Positive behavior included resting without orientation to the environment, while negative behaviors included barking, pacing, destruction, and house soiling, among others. For at least one negative behavior, a reduction of greater than 10% from Day 0 was seen for nine dogs at Day 28 and seven dogs at Day 42. While a caregiver placebo effect cannot be ruled out, this would not be expected to affect the video results. This proof-of-concept study provides promising evidence to warrant further evaluation in a sham-device controlled trial.

Treatment of Canine Separation Anxiety Using a Pulsed Electromagnetic Field Device: A Pilot Study

Margaret E. Gruen1, Emily Griffith2, Judy Korman3

1North Carolina State University College of Veterinary Medicine; 2 North Carolina State University College of Sciences; 3 Assisi Animal Health

Presented July 2019 at the IVBM Conference, Washington DC

Selected Case Examples

Tulip

  • Showed signs of CSA for many years- watched the door continuously and barked constantly when owner left her home, even when husband was home.
  • Owner rated signs as moderate on initial evaluation and rated signs as completely resolved by the end of the study.
  • Video analysis showed resolution of barking by Day 28, which persisted through Day 56. Orienting toward the environment improved 41% by Day 28 and 81% by Day 56.
  • Owner and husband were very happy with the results. One year later signs of CSA have not returned.

Granite

  • Adopted ~ 7 months before enrolling in the study.
  • Owner was most concerned with the bloody drool that appeared every time she left him in the crate when she left home.
  • Owner rated him as severe on initial assessment and as completely resolved by the end of the study.
  • Destructive behavior showed 44% improvement by Day 28 and 88% by Day 56; whining and orienting to environment also improved on video analysis. Owner is thrilled with results!
  • One year later, signs of CSA are still under control without medication and owner is able to work outside the home.

Denver

  • Owner noticed signs of SA starting after the death of her other dog about 9 months prior to enrolling in the study; tried trazodone but did not like the sedating side effects.
  • Owner lives in a senior community and was concerned that his barking would get them evicted; owner rated the dog as having moderate CSA initially and as significantly improved by Day 28.
  • Video analysis showed no barking and 42% improvement in orienting to the environment by Day 28. 

Cooper

  • Signs of CSA included orienting to the environment, whining and barking. No resting, playing or positive behavior occurred during the entire 60-minute baseline video.
  • After a month of treatment, positive behavior increased to nearly 64%, whining improved 97% and barking was resolved. Behaviors such as play and grooming were evident.
  • Owner noted significant improvement after a month of treatment as well.