None listed
Conditions
Brief summary
This study is a pilot study with delayed-start double-blinded (participant and outcome assessor) randomised sham-controlled trial with outcome measures collected at baseline, mid, and immediately post-intervention. This study aims to 1) evaluate the feasibility of high-definition transcranial grey noise stimulation (HD-tGNS) in individuals with generalised anxiety disorder (GAD), 2) evaluate the effect of HD-tGNS on the functional connectivity between key hubs of the anxiety/fear network, and 3) investigate the effect of HD-tGNS on clinical outcomes in individuals with GAD (as trends in anxiety, suffering, and wellbeing). Up to 24 participants will be targeted. HD-tGNS will be applied to key structures of the anxiety/fear network (main regions: amygdala, ACC, OFC, insula, parahippocampus). The intervention will be administered three times a week (30 minutes per session) for a total of 6 weeks (i.e. 18 sessions in total) using a 32-channel transcranial current stimulator (Starstim32 TES®, Neuroelectrics, Spain). Participants in the delayed-start group will receive Sham stimulation for the first three weeks followed by HD-tGNS for three weeks; whereas participants in the early-start group will receive HD-tGNS throughout the intervention phase (i.e. for a total of 6 weeks). Outcome measures include: Safety and Feasibility, the Generalised Anxiety Disorder Scale (GAD-7), Hospital Anxiety and Depression Scale (HADS), and the State-Trait Anxiety Inventory (STAI) for measures of anxiety, the WHO-5 wellbeing index as a measure of wellbeing, and Resting state electroencephalography (EEG). The outcomes of this study will help us to develop new brain stimulation treatments for people with GAD.
Interventions
High definition transcranial grey noise stimulation (HD-tGNS) will be applied to key structures of the anxiety/fear network [main regions: amygdala, anterior cingulate cortex (ACC), orbitofrontal cortex (OFC), insula, and parahippocampus]. The intervention will be administered three times a week (30 minutes per session) for a total of 6 weeks (i.e. 18 sessions in total) using a 32-channel transcranial current stimulator (Starstim32 TES®, Neuroelectrics, Spain). Participants in the delayed-start
High definition transcranial grey noise stimulation (HD-tGNS) will be applied to key structures of the anxiety/fear network [main regions: amygdala, anterior cingulate cortex (ACC), orbitofrontal cortex (OFC), insula, and parahippocampus]. The intervention will be administered three times a week (30 minutes per session) for a total of 6 weeks (i.e. 18 sessions in total) using a 32-channel transcranial current stimulator (Starstim32 TES®, Neuroelectrics, Spain). Participants in the delayed-start group will receive Sham stimulation for the first three weeks followed by HD-tGNS for three weeks; whereas participants in the early-start group will receive HD-tGNS throughout the intervention phase (i.e. for a total of 6 weeks). The intervention will be undertaken by a researcher experienced in administering neuromodulation techniques. Each participant will undergo the intervention individually at the department of surgical sciences at Dunedin Hospital. 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 small electrode size that can focally target deeper brain regions. The Ag/AgCl stimulation electrodes will be placed on a neoprene head cap following the International 10-20 EEG system. For the HD-tGNS, the stimulation will be delivered at a current strength of maximum of 2mA for 30min, with 60s ramp up and ramp down at the beginning and the end of each stimulation session, with continuous stimulation in between. Adherence of the intervention will be monitored using session attendance checklist.
Sponsors
Otago University
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 GAD 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.
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 stimulation, electroconvulsive therapy, Neurofeedback, etc.) · Dyslipidaemia · Cognitive impairments (Dementia, Alzheimer’s disease, personality disorders, substance use disorders, certain medical conditions): 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 or ongoing psychotherapy for the duration of the trial, with the type and dosage of medication/therapy being recorded throughout the duration of the trial. However, participants with the intention of taking new medications/therapies in the next 2 months, will be excluded.
Outcome results
None listed