ClinicalTrials.gg
CompletedNCT03305328Updated Oct 9, 2017

Assessing the Clinical Utility of tACS

An interventional study of Transcranial Alternating Current Stimulation in Anxiety Disorders and Symptoms, Sensory Disorders and Hypervigilance, sponsored by Florida State University. Completed. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-09.

Sponsored by Florida State University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Jul 2016, registered Oct 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 18 studies in Anxiety Disorders by Florida State University — 3 open to participants now, 6 under way, none of them phase 3. Anxiety Disorders · Florida State University.

Enrollment
16th of 18
38 · median 131
Started
2016
with 1 other
No phase
18 of 18
3 open now
Registered
7th of 18
by date

Among the 18 studies in Anxiety Disorders by Florida State University, this one is the 16th largest by enrollment, is one of 2 that started in 2016, is one of 18 with no phase, and was the 7th registered.

Anxiety Disorders

7,207 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

Browse Anxiety Disorders studies →

Open to participants now

3 of the 18 studies in Anxiety Disorders by Florida State University are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 944 Anxiety Disorders studies recruiting now, 417 (44%) set no upper age limit and 460 (49%) stop at 75 or younger; 233 take children under 18; 317 take healthy volunteers.

This study: 18 Years to 60 Years · all sexes · healthy volunteers too.

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02

Study summary

The present study seeks to evaluate the clinical utility of repeated transcranial alternating current stimulation (tACS) by assessing long-term, lasting changes in oscillatory activity and subsequent changes in related behavioral processes of anxious arousal and sensory sensitivity. To date, only transient effects of tACS have been reported, lasting no longer than 30 to 70 minutes. In order to be truly impactful within a clinical setting, however, evidence for long-term effects of tACS is needed.

Read the detailed description

Recent years have witnessed increasing recognition of "oscillopathies", neuropsychiatric disorders characterized by aberrations in the neural oscillations that orchestrate various mental activities. Transcranial alternating current stimulation (tACS) provides an effective way to directly modulate these oscillations in a non-invasive and frequency-specific manner, offering groundbreaking insights into the workings of the brain and, importantly, the development of novel treatments for these oscillopathies. However, evidence is lacking for the ability of tACS to induce long-term neural plasticity and lasting behavioral changes, which is critical for establishing the clinical utility of this novel intervention.

Here, we are administering 30 minutes of alpha-frequency tACS over occipitoparietal sites for four consecutive days to evaluate both transient and long-term changes in alpha oscillatory power and long-range, directed oscillatory connectivity. As both anxious arousal and sensory sensitivity are highly related to alpha oscillations, as well as numerous neuropsychiatric disorders, changes in these behavioral outcomes were subsequently evaluated to assess clinically-relevant outcomes of the repeated tACS protocol.

03

Conditions studied

  • Anxiety Disorders and Symptoms
  • Sensory Disorders
  • Hypervigilance
  • Post Traumatic Stress Disorder

Keywords

  • Oscillations
  • Non-invasive Brain Stimulation
  • Transcranial Alternating Current Stimulation
04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Right-handed

Exclusion criteria

Exclusion Criteria:

  • History of severe neurological disorder or traumatic brain injury
  • Psychotropic medication use
  • Metal plates/implants in head
  • Pregnancy
  • Implanted medical devices (e.x. pacemaker)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    Active

    Participants within the Active condition receive 30 minutes of alpha-frequency Transcranial Alternating Current Stimulation (tACS) stimulation for four consecutive days. Participants are stimulated at their baseline peak alpha frequency, or the frequency at which they exhibit maximal power within the 8 to 12 Hz range. Stimulation was administered over occipitoparietal sites, where tACS current models showed maximal effect over the dorsal extrastriate.

    Device: Transcranial Alternating Current Stimulation

  • Sham comparator
    Sham Control

    Participants within the Sham condition receive 30 minutes of sham Transcranial Alternating Current Stimulation for four consecutive days, during which no current was passed. To control for awareness of the Sham stimulation, all Sham control participants receive a brief, 10 second pulse of random noise stimulation at the beginning and end of the 30 minutes.

    Device: Transcranial Alternating Current Stimulation

Interventions

  • DeviceTranscranial Alternating Current Stimulation

    Transcranial Alternating Current Stimulation passes a weak, 2 mA sinusoidal current through the scalp to the cortex at a specified frequency. Previous evidence suggests this exogenous sinusoidal stimulation interacts with the endogenous, cortical sinusoidal oscillatory activity, resulting in modulations of cortical oscillations. The intervention is non-invasive and virtually painless with no lasting adverse side-effects.

06

What researchers measure

Primary outcomes

  1. Immediate and lasting changes in alpha oscillatory power and directed, long-range cortico-cortical connectivity.

    Occipitoparietal alpha power and long-range, directed oscillatory connectivity within the alpha frequency will be assessed from 2 minutes of eyes-open, resting-state electroencephalogram (EEG) activity. Oscillatory power will be estimated using the multitaper spectral estimation technique, averaging over the alpha frequency bin of 8-12 Hz. Directed connectivity will be assessed using spectral Granger causality within the 8-12 Hz range. Specifically, long-range, posterior-frontal connectivity with be assessed.

    Time frame: Immediately before, immediately after, and 30 minutes after stimulation on the first day. Immediately before (24 hours after most recent stimulation), immediately after, and 30 minutes after stimulation on the final (fourth) day.

Secondary outcomes

  1. Immediate and lasting reductions in anxious arousal

    Self-report ratings of subjective units of anxious arousal are acquired using a visual analog scale, ranging from 0 (not at all anxiously aroused) to 100 (extremely anxiously aroused).

    Time frame: Immediately before, immediately after, 30 minutes after stimulation on the first and final day. Immediately before (24 hours after most recent stimulation) and immediately after stimulation on the second and third days.

  2. Immediate and lasting changes in affective perception of sensory stimuli

    Pleasantness ratings of neutral and negative olfactory and auditory stimuli are acquired on a visual analog scale, ranging from 0 (extremely unpleasant) to 100 (extremely pleasant). Auditory stimuli consist of a simple tone (neutral) and scream (negative) at three different intensities (quiet, medium, and loud), each presented once for 2 seconds through headphones. Olfactory stimuli consist of a neutral odor (acetophenone) and negative odor (burning rubber), diluted in mineral oil for three different intensities (weak, medium, strong). Approximately 3 mL of each odor are presented in 30 mL amber bottles, upon which participants are asked to take one steady sniff.

    Time frame: Immediately before, immediately after, and 30 minutes after stimulation on the first day. Immediately before (24 hours after most recent stimulation), immediately after, and 30 minutes after stimulation on the final (fourth) day.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2016 to primary completion in Mar 2017, 8 months.

Of 3,841 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's 8 months is below that.

Counting every sponsor, half of 3,943 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 4, 2017
First posted
Oct 9, 2017
StartActual
Jul 29, 2016
Primary completionActual
Mar 31, 2017
CompletionActual
Mar 31, 2017
Last update
Oct 9, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03305328
Responsible party
Wen Li (Associate Professor, Florida State University) — Principal investigator
First posted
Oct 9, 2017
Start date
Jul 29, 2016
Primary completion
Mar 31, 2017
Completion
Mar 31, 2017
Last update
Oct 9, 2017

Study contacts

Wen Li, PhD
principal investigator · Florida State University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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