What this study is
Study to examine the extent to which neurophysiological states recorded for a specific person on one day can be induced on a subsequent day
What's being tested
- Transcranial alternating current stimulation (tACS)
Intervention · DEVICE
Transcranial alternating current stimulation (tACS) is a widely used non-invasive brain stimulation method. The concept underlying alternating current is to simulate the naturally occurring rhythmic pattern of electrophysiological activity of the brain, which can be detected by electroencephalography (EEG). It involves the application of electrodes onto the scalp, which deliver sinusoidal alternating electric currents.
- Neuro/biofeedback
Intervention · BEHAVIORAL
Participants will be shown their their brain EEG recordings and parameters from vocal recordings from their "backup" day, and asked to attempt to use behavioral strategies to match the recording
- Recall
Intervention · BEHAVIORAL
Participants will be given their subjective ratings and notes from a journaling interval to use as a target to restore their mood to how they were feeling on the Visit 1 backup day
- Physiological stimulation
Intervention · DEVICE
Facial electrical stimulation, and chest-worn vibroacoustic stimulation will be used to affect facial muscle activity and peripheral physiology to better approximate previously assessed states.
Study details
- Official title
- Restorative Neurophysiology: Feasibility of "Backup and Restore" Technologies for Brains and Bodies
- Sponsor
- University of Pittsburgh
- Conditions
- Adults With Variability in Their Mood
- Enrolling
- 60 people
- Starts
- 2026-01-01
- Est. completion
- 2029-03-01
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 65 YearsSex ALLHealthy volunteers AcceptedYou may qualify if
- Adults age 18-65
- Have periods of good and bad moods each lasting at least 2 days
You can't join if
- Refusal or inability to provide informed consent
- People who report being in frank psychotic episodes or who say they are unable to stay off psychoactive substances during assessments will be excluded. Because we do not want to return participants to manic states, individuals with bipolar I disorder who report being or appear to be in a manic state at their baseline assessment will also be excluded.
- Inability to complete questionnaires written in English. The justification is that many of the primary analyses involve assessment of change in self-reported symptoms using measures normed in English. Participants must thus be able to read those measures to give valid indications of the extent to which they have responded to the intervention.
- Chronic pain that could be exacerbated by electrical stimulation
- Having difficulties in corrected vision or hearing which would prevent efficient processing of the experimental stimuli
- Having a North American Adult Reading Test (NAART) equivalent full scale IQ < 85
- History of a convulsive disorder
- Presence of any neurologic disorder or medication therapy known to decrease seizure threshold (e.g., brain injury, frequent/severe headaches).
- Participants deemed "not a good fit" for the study for other reasons (such as, but not limited to, continually arriving late or rescheduling, not being a trustworthy historian or accurate reporter of symptoms, being belligerent with study staff, or presenting an active suicide risk) can also be excluded.
- Heart condition
- Current severe Diagnostic and Statistical Manual of Mental Disorders (DSM-V) alcohol or substance use disorder, with the exception of nicotine or caffeine. Clinician will access subjects' alcohol and substance use on a case-by-case to determine whether specific cases of mild or moderate alcohol or substance use would also interfere with the effects of the intervention.
- Those who have metal implants in the vicinity of stimulated areas, or who have electrical implants (e.g., pacemakers, vagus nerve stimulator) will be excluded out of an abundance of caution regarding the safety of electrical stimulation.
- Any metal implant or subcutaneous metal in the face or head
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Pittsburgh
Pittsburgh, Pennsylvania, United States
- Greg Siegle · Contact412-648-6179 ext. 412-864-3501gsiegle@pitt.edu
- Greg Siegle · Principal investigator
- Kymberly Young · Principal investigator
Study team
Sponsor
University of Pittsburgh
Study ID STUDY25020073
Principal investigator
Greg Siegle
University of Pittsburgh
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.