None listed
Conditions
Brief summary
This study investigates the effects of a new brain stimulation technique (a cap placed on the head that delivers a small amount of electricity to specific parts of the brain) aimed at reducing symptoms associated with anxiety and/or depression. Anxiety and depression pose significant and growing health challenges worldwide, with current treatments not being as effective as we need them to be. In individuals with anxiety and/or depression, previous research has shown abnormal brain patterns in the brain networks responsible for emotion. This study will use an electrical brain stimulation technique to try to change the brains communication patterns and improve symptoms of anxiety and/or depression. The results obtained from this study will help us to develop new interventions for improving symptoms in people with anxiety and/or depression.
Interventions
High-definition transcranial Infraslow Grey Noise Triple Network Neuromodulation (HD-tIGN-TNN) stimulation intervention will be administered three times per week for three (delayed-start arm [following 3-weeks of sham]), or six weeks (early-start arm), by a researcher experienced in administering neuromodulation techniques (i.e, 9, or 18 sessions in total, respectively). The Starstim-20 TES device (Neuroelectrics, Spain) will be used to deliver stimulation while participants are comfortably seat
High-definition transcranial Infraslow Grey Noise Triple Network Neuromodulation (HD-tIGN-TNN) stimulation intervention will be administered three times per week for three (delayed-start arm [following 3-weeks of sham]), or six weeks (early-start arm), by a researcher experienced in administering neuromodulation techniques (i.e, 9, or 18 sessions in total, respectively). The Starstim-20 TES device (Neuroelectrics, Spain) will be used to deliver stimulation while participants are comfortably seated. Stimulation electrodes will be placed following the 10/20 electroencephalography (EEG) system to target the triple brain network in its anti-correlated way and to dissociate the correlated activity of the triple brain networks. The optimal montage for the triple brain network stimulation is created using the Stimweaver optimization software by Neuroelectrics company. The placement of electrodes will be identical for both sham and HD-tIGN-TNN conditions. For the HD-tIGN-TNN condition, the stimulation will be delivered at a current strength of maximum of 4mA for 30min, with 60s ramp up and ramp down at the beginning and end of each stimulation session, with continuous stimulation in between. The grey noise stimulation at a current strength of maximum of 1.5mA will be superimposed on the infraslow stimulation waveform of a current intensity of 1.515mA, such that the current strength of the waveform never exceeds the maximum of 4mA. The intervention dosage is chosen based on previous studies by our group and following the safety guidelines. Intervention sessions are held at the Dunedin Public Hospital, New Zealand. A trained researcher will measure intervention adherence for all participants. Specifically, this will be recorded and monitored on a sheet where intervention attendance is logged per session.
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 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
Exclusion criteria 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