Skip to content

The Effects of Infraslow Neurofeedback in Anxiety and Depression (the ISAD study)

The ISAD (InfraSlow neurofeedback for Anxiety and Depression): a trans-diagnostic, randomized, double-blind, sham-controlled, dose-response, parallel-group trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001428156
Acronym
ISAD
Enrollment
60
Registered
2019-10-15
Start date
2020-02-15
Completion date
2021-06-01
Last updated
2022-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Brain imaging studies have shown that people with anxiety and/or depression have been found to have alterations within and between certain brain networks. Brain networks are a group of brain regions that work together to perform certain functions (e.g. daydreaming). We are interested in using electroencephalography (EEG) to study whether or not the very slow (infraslow) activity is altered in these brain networks and if infraslow neurofeedback (IS-NFB) can improve brain function and reduce symptoms of anxiety and depression. IS-NFB is a non-invasive technique that uses real time recordings of brain activity to teach you to self-regulate brain function by generate a sound when your brain exhibits the targeted infraslow brain activity.

Interventions

Infraslow neurofeedback (IS-NFB) is a non-invasive technique that uses real time recordings of brain activity to teach self-regulation of brain function via operant conditioning by generating a sound when the brain exhibits the targeted infraslow (<0.1 Hz) brain activity. Infra-slow neurofeedback is carried out with participants sitting upright in a comfortable chair. The first step is to apply the 19-electrode cap on the scalp. The electrodes on the cap, which are like little cup-shaped discs,

Infraslow neurofeedback (IS-NFB) is a non-invasive technique that uses real time recordings of brain activity to teach self-regulation of brain function via operant conditioning by generating a sound when the brain exhibits the targeted infraslow (<0.1 Hz) brain activity. Infra-slow neurofeedback is carried out with participants sitting upright in a comfortable chair. The first step is to apply the 19-electrode cap on the scalp. The electrodes on the cap, which are like little cup-shaped discs, are kept in place with a special conducting jelly put on them before attached to the scalp. The electrode cap will be connected to an amplifier and a computer which allow the recording of infraslow brain activity. Participants will be asked to close their eyes, relax and listen to the sound being played. 4 parallel arms: arm 1: 12 sessions of real IS-NFB modulating default mode network (DMN) activity (n=15 women) arm 2: 12 sessions of real IS-NFB modulating DMN & salience network (SN) connectivity (n=15 women) arm 3: 6 sessions of sham IS-NFB followed by 6 sessions of real IS-NFB modulating DMN activity (n=15 women) arm 4: 6 sessions of sham IS-NFB followed by 6 sessions of real IS-NFB modulating DMN & SN connectivity (n=15 women). IS-NFB will be performed individually on participants by a trained researcher with experience delivering IS-NFB treatment. Sessions will last 30 minutes and take place 3 times per week over 4 weeks. All interventions will take place in a clinic room at the University of Otago (Dunedin Hospital).

Sponsors

Tyson Perez
Lead SponsorIndividual

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 64 Years
Healthy volunteers
No

Inclusion criteria

1. Women aged 18-64 years with (re)current anxiety and/or depression (i.e. GAD, SOC, MDD) 2. No or stable use of medications for at least 4 weeks with no intention to change.

Exclusion criteria

1. Taking new medications (less than 4 weeks), short-acting benzodiazepines or other drugs that may influence autonomic activity (e.g. amphetamines) 2. Current externalising disorder (alcohol/substance use disorder, antisocial personality disorder, suicidality) 3. Current thought disorder (mania/bipolar disorder, psychoses) 4. Current pregnancy 5. Pacemaker 6. Tinnitus

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 11, 2026