None listed
Conditions
Brief summary
In people with anxiety/depression, disrupted functional connectivity of the brain regions of the Salience Network (SN), Central Executive Network (CEN), and Default Mode Network (DMN) have been observed in the infraslow frequency spectrum (less than and equal to 0.1 Hz). A novel approach disrupting the functional connectivity between the brain networks (vs activity in individual brain regions) could result in better clinical outcomes. The aim of the parent-study is to explore the trend of effect of multisession treatments of a non-invasive brain stimulation technique (i.e., HD-tIGN-TNN) on clinical outcomes. This sub-study will investigate the effect of a single session of the intervention on EEG measures, specifically whether a single session can normalize the functional connectivity disruptions between the key nodes of the targeted cortical networks (SN, CEN, DMN) in the infraslow frequency spectrum (0.1 Hz).
Interventions
For the active stimulation group, the HD-tIGN-TNN will be delivered by a researcher with experience in delivering neuromodulation techniques, for a single session of 30min with 60s ramp up and ramp down at the beginning and end, with continuous stimulation in between. The gray noise (50%) will be superimposed on the infraslow (0.1Hz) sinusoidal waveform (50%), with the maximum current strength of 2.0 mA per electrode and the maximum total current injected being 4.0mA. Adherence of the interventi
For the active stimulation group, the HD-tIGN-TNN will be delivered by a researcher with experience in delivering neuromodulation techniques, for a single session of 30min with 60s ramp up and ramp down at the beginning and end, with continuous stimulation in between. The gray noise (50%) will be superimposed on the infraslow (0.1Hz) sinusoidal waveform (50%), with the maximum current strength of 2.0 mA per electrode and the maximum total current injected being 4.0mA. Adherence of the intervention (i.e., duration of stimulation completed) will be recorded by the treating researcher. The HD-tIGN-TNN will be delivered using a 32-channel Starstim transcranial electrical stimulator to alter the functional connectivity strength between the three cortical networks [namely the salience network (SN), the default mode network (DMN) and the somatomotor network (SMN)] in the infraslow frequency spectrum (0.1 Hz). A total of 16 circular Ag/AgCl electrodes [twelve stimulation electrodes (C5, C6, CPZ, F5, FC1, FC2, FT7, FT8, FPz, O2, T8, and TP7) and four electrodes with zero current (PO3, POZ, PO4, and O1)] will be placed on a neoprene head cap following the International 10-10 EEG system. The optimal montages has been created using the Stimweaver optimization software by the Neuroelectrics company, to specifically decrease/disrupt the functional connectivity i.e., communication hubs within the SN (i.e., rostral Anterior Cingulate Cortex, Insula) and CEN (i.e., Temporal Occipital Junction, Frontal Up, Frontal Down) are to be inhibited, and DMN hubs (i.e., Posterior Cingulate Cortex, Ventromedial Prefrontal Cortex, Temporoparietal Junction, Hippocampus) are to be excited. This sub-study is conducted as part of the larger parent-trial (ACTRN12625000862448). It focuses specifically on the first treatment session of the parent-trial to investigate possible immediate outcomes from a single stimulation session. All participants enrolled in the parent-trial will partake in this sub-study, as outlined in the participant information sheet and consent form.
Sponsors
University of Otago Research and Enterprise Office
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Participants in this sub-study must be enrolled in the parent-study ACTRN12625000862448, for which the inclusion criteria are as follows (no further inclusion criteria are required for this sub-study): Participants with a diagnosis of anxiety and/or depressive disorders (i.e., generalized anxiety disorder, panic disorder, social anxiety disorder, post-traumatic stress disorder, phobias, separation anxiety disorder, major depressive disorder, persistent depressive disorder) will be eligible to enroll in this study. Participants will need to be capable of understanding the study information and able to sign the informed consent form and: • Aged between 18 to 45 years on the day of the consent. • Have a total score of greater than or equal to 11 on the HADS, consistent with moderate or greater anxiety/depression severity.
Exclusion criteria
Participants in this sub-study must be enrolled in the parent-study ACTRN12625000862448, for which the exclusion criteria are as follows (there are no further exclusion criteria for this sub-study): Participants who meet any of the following conditions will be excluded: • History of neurological disorders. • History of epilepsy or seizures. • History of substance abuse (i.e., consuming more than 3 drinks on any day or more than 7 drinks per week for women, and more than 4 drinks on any day or more than 14 drinks per week for men). • Previous treatment with neuromodulation (e.g. Transcranial magnetic or electrical stimulation, electroconvulsive therapy, Neurofeedback, etc.). • Personality disorder, including borderline personality disorder. • Cognitive impairments (e.g., dementia, Alzheimer’s disease, etc.): 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) that could impact the quality of physiological measurements. • Recent (past six-months) or current pregnancy. • Participants with current active suicidal ideation, assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS)
Outcome results
None listed