Anxiety Disorders and SymptomsNCT03305328
Assessing the Clinical Utility of tACS
A study testing Transcranial Alternating Current Stimulation in people with Anxiety Disorders and Symptoms and Sensory Disorders, run by Florida State University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anxiety Disorders and Symptoms, Sensory Disorders, Hypervigilance
- What is being tested?
- Transcranial Alternating Current Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- No sites listed yet
- Study dates
- 29 Jul 2016to 31 Mar 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Right-handed
Who cannot join
- History of severe neurological disorder or traumatic brain injury
- Psychotropic medication use
- Metal plates/implants in head
- Pregnancy
- Implanted medical devices (e.x. pacemaker)
About this study
Official title: Assessing the Clinical Utility of tACS in the Treatment of Anxious Arousal and Sensory Sensitivity
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.
- Conditions
- Anxiety Disorders and Symptoms, Sensory Disorders, Hypervigilance, Post Traumatic Stress Disorder
- Being tested
- Transcranial Alternating Current Stimulation
- Keywords
- Oscillations, Non-invasive Brain Stimulation, Transcranial Alternating Current Stimulation
- Medical subject headings
- Anxiety Disorders, Sensation Disorders, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Alternating Current StimulationDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | 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. Receives: Device: Transcranial Alternating Current Stimulation |
| Sham Control | Sham comparator | 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. Receives: Device: Transcranial Alternating Current Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 (2)
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).
Measured: 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.
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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start29 Jul 2016
- Primary completion31 Mar 2017
- Study completion31 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety Disorders and SymptomsStudies of the same condition, open and under way.
- More trials run by Florida State UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to either an Active or Sham Control group. The Active group received the 30 minutes of alpha-tACS for four consecutive days, whereas the Sham Control group received Sham (no) stimulation.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen Li, Florida State University
- Investigators
- Wen Li, PhD, Principal investigator, Florida State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305328
- Sponsor's protocol ID
- 2017.20700
- Other IDs
- 2017
- Status last verified
- Oct 2017
- First submitted
- 4 Oct 2017
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Clinical Utility of tACS in the Treatment of Anxious Arousal and Sensory Sensitivity
- ClinicalTrials.gov ID
- NCT03305328
- Acronym / sponsor ID
- 2017.20700
- Conditions
- Anxiety Disorders and Symptoms, Sensory Disorders, Hypervigilance, Post Traumatic Stress Disorder
- Keywords
- Oscillations, Non-invasive Brain Stimulation, Transcranial Alternating Current Stimulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 29 Jul 2016 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 31 Mar 2017 (actual)
- First posted
- 9 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to either an Active or Sham Control group. The Active group received the 30 minutes of alpha-tACS for four consecutive days, whereas the Sham Control group received Sham (no) stimulation.
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Device: Transcranial Alternating Current StimulationParticipants 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. |
| Sham Control | Sham comparator | Device: Transcranial Alternating Current StimulationParticipants 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Right-handed
Key exclusion criteria (5 listed)
- History of severe neurological disorder or traumatic brain injury
- Psychotropic medication use
- Metal plates/implants in head
- Pregnancy
- Implanted medical devices (e.x. pacemaker)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transcranial Alternating Current StimulationTranscranial 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. | Device | Active, Sham Control |
Primary outcome
Immediate and lasting changes in alpha oscillatory power and directed, long-range cortico-cortical connectivity.
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.
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.
2 secondary outcomes
Immediate and lasting reductions in anxious arousal
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.
Immediate and lasting changes in affective perception of sensory stimuli
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Anxiety Disorders and Symptoms
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Not yet recruiting
Effect of Box Breathing Exercise on Anxiety, Pain, and Pulmonary Function Tests in Patients Undergoing Colonoscopy
Colonoscopy
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wen Li, PhD principal investigator
Florida State University
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial Alternating Current Stimulation in people with Anxiety Disorders and Symptoms and Sensory Disorders, run by Florida State University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Immediate and lasting changes in alpha oscillatory power and directed, long-range cortico-cortical connectivity. (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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2017.