High-definition transcranial grey noise stimulation (HD-tGNS) as an intervention for generalised anxiety disorder (GAD): A proof of concept study

Not Applicable

• Conditions: Generalised Anxiety Disorder; Mental Health - Anxiety

• Registration Number: ACTRN12623000250639
• Lead Sponsor: Otago University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-08
• Last Update Posted: 20 March 2023

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale (HADS) [Baseline, midway through the experiment (i.e., at three weeks post-commencement of intervention), and immediately post-intervention period (i.e., at six weeks post-commencement of intervention)];Generalised Anxiety Disorder Scale- 7 (GAD-7) [Baseline, midway through the experiment (i.e., at three weeks post-commencement of intervention), and immediately post-intervention period (i.e., at six weeks post-commencement of intervention)];Resting state brain activity and functional connectivity measured by Electroencephalography (EEG) [Baseline, midway through the experiment (i.e., at three weeks post-commencement of intervention), and immediately post-intervention period (i.e., at six weeks post-commencement of intervention)]