BTL EXOMIND™ Publishes a New Clinical Paper

ExoTMS™ Technology: A Novel Breakthrough in Transcranial Magnetic Stimulation for Enhancing Mental Well-Being

Michelle Dees, Yael Halaas, JD McCoy

BTL has published a peer-reviewed clinical study on ExoTMS™ technology, highlighting significant improvements in mental well-being following treatment. The clinical trial, published in the Journal of Psychiatry and Psychiatric Disorders, evaluated the effects of ExoTMS™ across 33 adult participants with a range of baseline well-being and reported consistent improvements in psychological health, comfort, and overall satisfaction.

Participants underwent four treatments targeting the left dorsolateral prefrontal cortex (DLPFC) using the EXOMIND device (BTL Industries, Boston, MA, USA) with ExoTMS™ Technology. The individual treatments were spaced 5–10 days apart.  Follow-up visits were scheduled 1 month and 3 months after the final treatment. The validated Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) was administered at baseline, after the final treatment, and at both follow-up visits to assess post-treatment changes in mental well-being.

At 3 months, over 70% of participants reported that the treatments improved their mental wellness and mood. They felt less stressed, happier, in a good mood, more calm, had more mental energy, were able to stay more focused, thought more positively, found it easier to fall asleep and their sleep quality improved. Additionally, 60-70% of participants reported feeling less nervous, anxious and depressed, more motivated and confident, as well as handling challenging situations better, and being more engaged with daily activities.

Among participants diagnosed with depression, at 3 months, over 80% reported the treatments improved their mental wellness and mood, feeling less depressed and stressed, being in a good mood after the treatments, thinking more positively, and finding it easier to fall asleep.

90.9% of subjects found the treatment comfortable. The average score on the Numerical Rating Scale for pain was 0.2±0.8 out of 10 points, indicating the treatment was painless.

While further controlled studies are warranted, these early findings highlight the strong potential of ExoTMS™ in supporting mental wellness.

STUDY ABSTRACT

Background: Mental well-being encompasses emotional, psychological, and social health. In today’s world, new stressors and challenges continue to emerge, contributing to a decline in overall well-being. This study aims to evaluate the effects of ExoTMS™ brain stimulation technology on enhancing mental well-being and assessing subject satisfaction, therapy comfort, and procedural safety.

Methods: 33 subjects (n= 33, 26 females, 7 males, 49.8±15.1 years) received 4 ExoTMS™ sessions. The Warwick-Edinburgh Mental Well-Being Scale (WEMWBS) was used to assess mental well-being at baseline, after the final treatment, and at the 1-month and 3-month follow-ups. Subject satisfaction, therapy comfort and procedural safety were also recorded.

Results: The observed changes in WEMWBS scores were statistically significant (p<0.001), with an average increase of 6.7±6.4 points post-treatment, 7.6±8.0 points at 1 month, and 6.8±8.0 points at 3 months. The percentage of participants experiencing an increase in WEMWBS scores was 78.8% post-treatment, 84.8% at 1 month, and peaked at 87.5% at 3 months. Subjects self-reported improvements in mood, confidence, mental energy, the feelings of stress, depression, anxiety, as well as sleep onset and quality. 90.9% of subjects found the treatments comfortable.

Conclusion: The study results indicate ExoTMS™ treatments as a promising approach in enhancing mental well-being, showing efficacy across all WEMWBS well-being categories, from low to high. The noninvasive treatment reached significant results with four sessions, while ensuring high therapy comfort and subject satisfaction.

DOI: 10.26502/jppd.2572-519X0255