Clinical trial NCT03305328: Assessing the Clinical Utility of tACS
Official title: Assessing the Clinical Utility of tACS in the Treatment of Anxious Arousal and Sensory Sensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders and Symptoms
Sensory Disorders
Hypervigilance
Post Traumatic Stress Disorder
Keywords: Oscillations
Non-invasive Brain Stimulation
Transcranial Alternating Current Stimulation
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2017-10-09
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* Right-handed

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)

Primary outcomes:
measure: Immediate and lasting changes in alpha oscillatory power and directed, long-range cortico-cortical connectivity.
timeFrame: 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:
measure: Immediate and lasting reductions in anxious arousal
timeFrame: 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.
measure: Immediate and lasting changes in affective perception of sensory stimuli
timeFrame: 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.
Other outcomes:
Locations:
Study officials:
affiliation: Florida State University
name: Wen Li, PhD
role: PRINCIPAL_INVESTIGATOR
References: