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NCT Number: NCT07252011

Restorative Neurophysiology: Backing up and Restoring the Brain (BandR)

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location status: Recruiting

Location contact

Greg Siegle

CONTACT

[email protected]

412-648-6179 ext. 412-864-3501

Greg Siegle

PRINCIPAL_INVESTIGATOR

Kymberly Young

PRINCIPAL_INVESTIGATOR

About this study

The study will be a single-arm design. It involves a longitudinal design in which subjective, physiological, and brain reactivity will be measured on 3 occasions, between ~2 weeks and ~4 months apart. The first assessment will be on a subjectively "good" day (mood rating above 7/10). The second will be on a subjectively "bad" day (mood rating below 3/10) and the third will be within a week of the second session. At the second and third sessions, participants will work to "restore" their brain state to that of the first assessment.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

transcranial alternating current stimulation (tACS)

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

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

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

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.

Primary outcomes

  1. Mean Change in electroencephalogram (EEG) Activity Across 4 Frequency Bands from Baseline

    Time frame: 4 months

    Change in the cosine of pre- and post- vectors for alpha, beta, theta, and gamma band activity from the first to third session

  2. Mean Change in Happiness Visual Analogue Scale (VAS) Ratings From Baseline

    Time frame: 4 months

    Change in Happiness VAS rating (on a scale from 0-100) from the first to third session

Study contacts

Contact information is provided by the study sponsor or research team.

Greg Siegle, PhD

CONTACT

[email protected]

412-864-3501

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Restorative Neurophysiology: Feasibility of "Backup and Restore" Technologies for Brains and Bodies

Acronym: BandR

Important dates

Study start
2026
Primary completion
2029
Study completion
2029
First posted
Nov 26, 2025
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.