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Clinical Research
ACTIVE RESEARCH PROTOCOLS
Resting state fMRI in SUD subjects treated with rTMS (BrainStud)
In order to identify and monitor changes in neural activity in brain areas, and the main associated predictors in substance use disorder (SUD) treated with rTMS, the Novella Fronda Foundation team will employ functional magnetic resonance imaging (fMRI) before, during and after rTMS treatment.
Current and ongoing research.
Partners: Villa Maria Nursing Home (Padua) and the National Institute on Drug Abuse (NIDA).
rTMS: a randomized double-blind study on gambling addiction patients
With the aim of evaluating the effects of rTMS in the treatment of gambling disorder, the Novella Fronda Foundation team is conducting a randomized double-blind study, including fMRI monitoring of functional connectivity.
Current and ongoing research.
Partners: Villa Park Napoleon Nursing Home (Preganziol, Italy), the National Institute on Drug Abuse (NIDA), University of Padua.
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Changes in cortical networks in patients with cocaine use disorder following the use of repetitive transcranial magnetic stimulation (rTMS)
The goal is to research and monitor changes in functional cortical connectivity in patients with cocaine use disorder (CUD), measured through electroencephalography, before, during and following treatment associated with repetitive transcranial magnetic stimulation (rTMS).
Current and ongoing research.
Partner: The European University of Rome
Assessment of substance-associated imaging reactivity in CUD patients undergoing rTMS
This study aims to research the pre-post rTMS variation of the emotional impact in CUD patients when exposed to visual images of different categories (including those associated with the drug) evaluated in the dimensions of valence, arousal and craving.
Current and ongoing research.
Partner: Department of General Psychology (University of Padua).
Main scientific researches carried out:
Transcranial magnetic stimulation of dorsolateral prefrontal cortex reduces cocaine use: A pilot study.
In 2015 the research team of the Novella Fronda Foundation conducted a pilot study on the clinical effects of rTMS in patients suffering from cocaine addiction. The results of this study were published in 2016 in the scientific journal European Neuropsychopharmacology and aroused great interest from scholars and public opinion, both nationally and internationally.
This work has made it possible to provide preliminary confirmation that it is possible to modify the malfunction of some brain networks that give rise to cocaine addiction and, in all likelihood, many other addictions as well. In fact, the action of rTMS on neuronal plasticity appears to have the potential to restore to normal the alterations of the brain areas that have been affected by the use of cocaine.
rTMS: psychological and behavioural changes in cocaine addicted patients
The study involved 284 patients with cocaine use disorder who voluntarily underwent rTMS treatment and who were being observed for a period of approximately 3 years. The main objective was to evaluate the changes in their cocaine consumption pattern, as well as ascertain the safety of the treatment method. The obtained results were very encouraging. Patients, as a whole, presented a significant reduction in their cocaine use, both in terms of frequency and quantity. Furthermore, the side effects associated with rTMS were demonstrated to be very small and transient in nature.
The results of the study were published in the international scientific journal Frontiers Psychiatry. Thanks also to this work, which in terms of patient number and observation time appears unique in its kind, the European regulatory bodies attributed the CE mark to rTMS for the treatment of psychoactive substances on 27 April 2021, indicating that the medical device is to be considered effective and safe and therefore can be used all over the world.
Partners: University of Padua.
rTMS: sleep pattern changes and secondary symptoms in cocaine addicted patients
Alongside the alterations in the level of dopamine, the neurotransmitter responsible for the pleasure sensation, the use of cocaine causes a change in sleep pattern, which becomes fragmented, of poor quality and is no longer restful. In addition, cocaine-addicted patients experience mood alterations, such as anxiety and depression. In this study, the research team analysed sleep and mood indicators of 87 CUD patients, before, during and after rTMS treatment. As a result of rTMS, a statistically significant percentage reported an improvement of their sleep and a reduction in anxiety and depression symptoms within the first five days of treatment. This improvement remained stable in the following 3 months of observation.
The results of our study were published in the international scientific journal BMC Psychiatry.
Partner: University of Padua
rTMS: treatment of cocaine and gambling addicted patients
Gambling disorder (GD) is a serious behavioural addiction that has numerous similarities with other addictions, such as cocaine addiction. The Novella Fronda Foundation has published a first publication on this topic. The study sample included 7 patients with CUD comorbid with GD. The study analysed the clinical effects of rTMS on the left dorsolateral prefrontal cortex and found that the symptoms of both disorders significantly decreased following treatment.
The results of our study were published in the international Journal of Clinical Medicine.