Recruiting

Observational Study

Sponsor:

University of Pittsburgh

Code:

NCT07252011

Conditions

Adults With Variability in Their Mood

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

Transcranial alternating current stimulation (tACS)

Neuro/biofeedback

Recall

Physiological stimulation

Study Details

Brief summary:

Study to examine the extent to which neurophysiological states recorded for a specific person on one day can be induced on a subsequent day

Conditions

Adults With Variability in Their Mood

Study ID

NCT07252011

Start date

Jan 1, 2026

Status verified date

Mar, 2026

Completion date

Mar 1, 2029

Anticipated

Primary completion date

Mar 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Adults age 18-65
  • have periods of good and bad moods each lasting at least 2 days

Exclusion Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Intervention Model

Single group

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

experimental: Recall + Stimulation + Neurofeedback

Participants will be given their subjective ratings and notes from the first session and asked to recreate how they were feeling at their first session during recall-only blocks. In addition, during neurofeedback and stimulation blocks, they will be given access to technologies for restoring neurophysiological features from the first assessment, including their 1) brain state, 2) facial muscle activity, and 3) heart rate variability. They will be provided with this information and asked to match their previous recordings during the neurofeedback blocks, and stimulated using Transcranial alternating current stimulation (TACS), electromyography (EMG), and vibroacoustic stimulation during the stimulation blocks.

Interventions

Transcranial alternating current stimulation (tACS)

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

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

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

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.

Primary outcome measure

  • Mean Change in electroencephalogram (EEG) Activity Across 4 Frequency Bands from Baseline [ Time Frame: 4 months ]
  • Mean Change in Happiness Visual Analogue Scale (VAS) Ratings From Baseline [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Greg Siegle, PhD

412-864-3501gsiegle@pitt.edu

Locations

University of Pittsburgh

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Greg Siegle

412-648-6179gsiegle@pitt.edu

Principal Investigator:

Greg Siegle

More Information

Sponsor

University of Pittsburgh

Last update posted

Mar 3, 2026

Last verified

Mar, 2026

Keywords

  • mood-variability
  • brain stimulation
  • neurofeedback
  • Positive memory recall
  • Transcranial alternating current stimulation (tACS)
  • electroencephaolography (EEG)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Pittsburgh on 2026-03-03.