What are Clinical Trials?
A clinical trial is a type of study which involves research using human participants with the intention to build and develop medical knowledge in a particular field, such as tinnitus. These trials further our understanding of medical treatments, diagnoses, the prevention of diseases or conditions, and more.
Many clinical trials are sponsored by pharmaceutical, biotech, or medical device companies to test the efficacy of a new device or drug. They’re widely regarded as the most responsible method of developing new medical interventions from initial research to widespread use in patients.
During clinical trials, participants receive different medical interventions (i.e. devices or drugs) which are applied under the supervision of medical or research experts. This team of experts monitor participants closely to watch out for how individuals react to the intervention.
For example, in our TENT-A1 trial, 326 participants were issued with a Lenire device for use during a 12-week treatment period. Trials are led by a principal investigator (PI) and the PI’s research team are all qualified healthcare professionals or experts in a particular field of science.
Peer Reviewed Research
Publication of medical research conducted during a clinical study is important as it acknowledges the scientific accuracy and validity of the research. This allows healthcare professionals to trust the scientific information that has been published about the treatment or condition which was investigated and ultimately helps the adoption of new medical practices.
During the peer review process, the findings of a clinical trial are put under the scrutiny of independent experts in the same field of medicine and research as the trial organisers. These experts validate and evaluate the claims made in the study, as well as its methodologies, and judge if it is suitable for publication in a medical journal.
Since 2015, Neuromod Devices has conducted clinical trials with Lenire’s bimodal neuromodulation technology. To date, more than 500 patients have enrolled in trials across Ireland and Germany. These studies took place at St. James’ Hospital, Dublin in Ireland and at the Tinnitus Centre, University Hospital Regensburg, Germany. The results have been very positive.
Real-world data of patients’ treatment outcomes with Lenire is consistent with the outcomes of Neuromod’s large-scale clinical trial, TENT-A1. An independent analysis of real-world patients of Lenire has demonstrated its ability to reduce the symptoms of tinnitus.
The data analysis of the effectiveness of Lenire for real-world patients was conducted at the German Hearing Center (DHZ) at Hannover Medical School in Germany.
This study showed that six to 12 weeks of treatment using Lenire can safely achieve clinically meaningful improvements in tinnitus symptom severity in a real-world clinical setting. The results of this study were published in the journal, Brain Stimulation in February 2022.