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

March 2, 2026 updated by: Greg Siegle, University of Pittsburgh

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh
        • Contact:
        • Principal Investigator:
          • Greg Siegle
        • Principal Investigator:
          • Kymberly Young

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Device: 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.
Behavioral: 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
Behavioral: 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
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
4 months
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
4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Investigators

  • Principal Investigator: Greg Siegle, University of Pittsburgh

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

March 1, 2029

Study Completion (Estimated)

March 1, 2029

Study Registration Dates

First Submitted

November 18, 2025

First Submitted That Met QC Criteria

November 18, 2025

First Posted (Actual)

November 26, 2025

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY25020073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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