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

NCT07252011 | Recruiting

• 1 other identifier: STUDY25020073
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

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

  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

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

  4 months

Study Arms (1)

Recall + Stimulation + Neurofeedback

EXPERIMENTAL

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); Behavioral: Neuro/biofeedback; Behavioral: Recall; Device: Physiological stimulation

Interventions

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 + Stimulation + Neurofeedback

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

Recall + Stimulation + Neurofeedback

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.

Recall + Stimulation + Neurofeedback

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.

Recall + Stimulation + Neurofeedback

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify 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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

RECRUITING

MeSH Terms

Interventions

Transcranial Direct Current Stimulation; Biofeedback, Psychology

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Convulsive Therapy; Psychiatric Somatic Therapies; Behavioral Disciplines and Activities; Electroshock; Psychological Techniques; Mind-Body Therapies; Complementary Therapies; Behavior Therapy; Psychotherapy; Feedback, Psychological

Study Officials

• Greg Siegle

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Greg Siegle, PhD

CONTACT

412-864-3501; gsiegle@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 26, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: March 3, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)