None listed
Conditions
Brief summary
The purpose of this study is to evaluate the safety and to explore the effect of a new brain stimulation technique on brain signals related to suffering and symptoms of depression in people diagnosed with Major Depressive Disorder. This study will involve stimulating the activity of the brain regions that have been associated with attention and self-identity. Altered communication between these brain areas has been associated with depression and its associated suffering. The results obtained from this study will help us to develop new treatments for improving health outcomes (feelings of suffering and symptoms of depression) in individuals diagnosed with depression. It is our hypotheses that: • The HD-tGNS technique targeting key structures of the brain associated with attention and self-identity will improve unhealthy signals related to repetitive, negative, self-image/thoughts and depression in patients with Major Depressive Disorder. • Compared to the placebo (sham) stimulation technique, the HD-tGNS technique will change activity and functional connectivity in the resting-state brain networks, particularly in/of the areas of interest. • These changes in activity and functional connectivity between the resting-state brain networks will show improvement alongside improvement in clinical outcomes.
Interventions
Intervention name: High Density Grey Noise Stimulation (HD-tGNS).
High-definition transcranial grey noise stimulation (HD-tGNS) will be used to disrupt pathological connectivity and restore normal function. Key structures of the Salience Network (SN) (Right Insular Cortex (RIC) and dorsal Anterior Cingulate cortex (dACC)) and Default Mode Network (DMN) (pregenual Anterior Cingulate Cortex (pgACC), and Posterior Cingulate Cortex (PCC)) will be targeted. The program required will be designed by N
Intervention name: High Density Grey Noise Stimulation (HD-tGNS). High-definition transcranial grey noise stimulation (HD-tGNS) will be used to disrupt pathological connectivity and restore normal function. Key structures of the Salience Network (SN) (Right Insular Cortex (RIC) and dorsal Anterior Cingulate cortex (dACC)) and Default Mode Network (DMN) (pregenual Anterior Cingulate Cortex (pgACC), and Posterior Cingulate Cortex (PCC)) will be targeted. The program required will be designed by Neuroelectrics® with the goal of restoring healthy functional communication between these brain regions. HD-tGNS will be administered three times a week (30 minutes/session) for a total of six weeks (i.e. 18 sessions in total) by a researcher experienced in administering neuromodulation techniques. A battery-driven wireless 32 channel transcranial current stimulator (Starstim32 TES®, Neuroelectrics, Spain, http://www.neuroelectrics.com) will be used to deliver stimulation while the participants are comfortably and quietly seated. The Starstim32 is a high definition system with multiple small electrode (size: 1 cm radius) that can focally target deeper brain regions. Thirty-two circular Ag/AgCl stimulation electrodes will be placed on a neoprene head cap. A 10-20 international placement EEG system will target the pgACC, PCC, dACC, and RIC and simultaneously to collect EEG data regarding functional connectivity. The optimal montages to target the network activity of the pgACC, PCC, dACC, and RIC will be created using the Stimweaver optimization software by the Neuroelectrics company. The placement of the electrodes will be identical for both the intervention groups. The stimulation will be delivered continuously at a current strength of maximum of 2mA for 30min, with 60s ramp up and ramp down at the beginning and end of each stimulation session. The intervention dosage is chosen based on the safety guidelines of previous TES studies. The intervention will be administered in person at the Otago Brai3n Laboratory of the Dunedin School of Medicine. To assess adherence to the intervention, session attendance, drop-out rates, and participant satisfaction levels will be recorded. Adherence to the intervention will be measured as the number of treatment sessions attended by each participant and will be expressed as a percentage of the total number of sessions. Once the treatment phase is completed, adherence rates will be calculated. Conversely, drop-out rates will be measured as the number of participants who drop out in each group, expressed as a percentage of the total number of participants enrolled in the study. Drop-out rates will calculated on the follow-up phase is completed. Finally, participant satisfaction levels and acceptability for HD-tGNS as a treatment will be recorded on an 11-point numeric rating scale (0-Not at all satisfied/acceptable to 10-very satisfied/acceptable).
Sponsors
Dirk De Ridder
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
Participants with a diagnosis of MDD will be eligible to participate. To be included in the study, participants must meet all of the following inclusion criteria: • Capable of understanding the study information and able to sign the informed consent form. • Age between 18 to 60 years on the day of the consent. • A score lower than three on the Maudsley Staging Method for treatment resistant depression.
Exclusion criteria
Participants who meet any of the following conditions will be excluded: • Other mental illness • History of neurological diseases • History of epilepsy or seizures • History of substance abuse, • Previous treatment with neuromodulation (e.g. Transcranial magnetic stimulation, electroconvulsive therapy, Neurofeedback, etc.) • Dyslipidaemia • Cognitive impairments (dementia, post-traumatic stress disorders, Alzheimer’s disease): A total score of 24 or below on Mini-Mental State Examination • History of uncontrolled/untreated hypertension • Presence of any pacemaker or defibrillator • Presence of any electronic implants or metal implant in the body (particularly head and neck) • Recent or current pregnancy Note ~ Participants will be permitted to continue their medications for the duration of the trial, with the type and dosage of medication being recorded throughout the duration of the trial. However, participants with the intention of taking new medications in the next 2 months, will be excluded.
Outcome results
None listed