Amygdala Temporal Interference Stimulation for Depression
This study aims to evaluate the effects of amygdala temporal interference stimulation on reducing depressive symptoms in individuals with depression.
Nervio-X
Mental Disorders+1
+ Depressive Disorder, Major
+ Depressive Disorder
Treatment Study
Summary
Study start date: July 24, 2024
Actual date on which the first participant was enrolled.This clinical trial is focused on exploring a new way to help people with depression by using a special method that stimulates a part of the brain called the right amygdala. This area is known to play a role in emotions and mood regulation. The study aims to see if this targeted brain stimulation can effectively reduce symptoms of depression. Depression is a common condition that can severely impact daily life, so finding new treatments is important to offer more options to those affected. Participants in the study will undergo a brain stimulation procedure, which carefully targets the right amygdala to potentially improve their mood and overall mental health. The study will assess the treatment's effectiveness by monitoring changes in depressive symptoms, cognitive abilities, and how well participants can perform daily activities. Safety is also a key focus, ensuring that the procedure does not pose any significant risks to the participants. By carefully measuring these outcomes, the study aims to provide valuable insights into whether this innovative approach can offer a new avenue for treating depression.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.92 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalGroup II
ShamStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 3 locations
Ruijin Hospital
Shanghai, ChinaTianjin Anding Hospital (Mental Health Center of Tianjin Medical University)
Tianjin, China