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Developing Alternative Treatments for Young People with Depression: A study of transcranial alternating current stimulation (tACS).

Developing Alternative Treatments for Young People with Depression: A study of transcranial alternating current stimulation (tACS).

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001705279
Acronym
You-tACS
Enrollment
55
Registered
2018-10-16
Start date
2019-06-12
Completion date
2022-02-17
Last updated
2022-05-09

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

Conditions

None listed

Brief summary

This study aims to test the effectiveness of Transcranial Alternating Current Stimulation (tACS), a gentle non-invasive brain stimulation technique, in treating young people (16-30 years old) with depression. Participants will be randomised into three groups; theta tACS, alpha tACS or sham stimulation and will receive 30 treatment sessions over four-weeks. Depressive symptoms and cognition will be assessed pre-treatment, mid-treatment phase, post-treatment and at 3 month follow-up. It is anticipated that that active tACS will improve both depressive symptoms and cognition compared to sham tACS.

Interventions

tACS treatment frequency will be determined during an EEG recording (see EEG assessment section below for details on EEG recording equipment). During the EEG recording, the N-back working memory task will be administered to participants to elicit theta oscillations, and the Sternberg working memory task will be administered to elicit alpha oscillations. Stimulation frequency will then be set to each individual’s theta and alpha frequency measurements, depending on the treatment allocated. The cu

tACS treatment frequency will be determined during an EEG recording (see EEG assessment section below for details on EEG recording equipment). During the EEG recording, the N-back working memory task will be administered to participants to elicit theta oscillations, and the Sternberg working memory task will be administered to elicit alpha oscillations. Stimulation frequency will then be set to each individual’s theta and alpha frequency measurements, depending on the treatment allocated. The current of tACS delivered 48,000 cycles (i.e. 20 mins) with no DC current offset. The current ramps gently over a period of e.g. 5-10 seconds to the desired peak for patient comfort. The stimulator fade in and fade out was specified to 100 cycles at the beginning and end of stimulation. A pair of 5x5cm electrodes placed within saline soaked sponges and a purpose-built battery-driven constant stimulator will deliver the current. The electrodes will be placed over the left pre-frontal cortex on F5 and, over the right pre-frontal cortex on F6, located using the 10-20 EEG position. This electrode montage has been modelled to show a reasonably widespread current flow through fronto-central cortical and frontal subcortical regions. tACS treatment course: The tACS course is a 4 week program that has two phases. A ‘lead in/out’ phase that happens at week 1 and week 4 and an intensive phase that happens during week 2 and week 3. • Week 1 and week 4 – one 20 minute session of tACS per day for 5 days a week (Monday to Friday) • Week 2 and week 3 – two 20 minute sessions of tACS per day with at least 4 hours break between sessions, for 5 days a week (Monday to Friday).

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
16 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

-Diagnosis of major depressive episode (MDE), in accordance with the Mini International Neuropsychiatric Interview - Individuals between 16 to 30 years of age - Depression severity quantified using the Montgomery-Asberg Depression Rating Scale (MADRS) cut-off scores (mild: 7-19; moderate: 20-34; severe: >34) - No more than 2 previously received adequate trials of antidepressant treatment - Demonstrated capacity to give informed consent

Exclusion criteria

-Inability to give informed consent -DSM V diagnoses of a psychotic disorder or current substance-use disorders; -Developmental disorders (including autism); -History of sustained head injury; -Other neurological illness; -Intellectual disability; -Major medical illness impacting brain function -Pregnancy

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026