Adults With Variability in Their MoodBandRNCT07252011
Restorative Neurophysiology: Backing up and Restoring the Brain (BandR)
A study testing Transcranial alternating current stimulation (tACS), Neuro/biofeedback and Recall in people with Adults With Variability in Their Mood, run by University of Pittsburgh at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Adults With Variability in Their Mood
- What is being tested?
- Transcranial alternating current stimulation (tACS), Neuro/biofeedback and Recall
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2026to 1 Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults age 18-65
- have periods of good and bad moods each lasting at least 2 days
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Greg Siegle, 412-648-6179 ext. 412-864-3501, gsiegle@pitt.edu
Greg Siegle
About this study
Official title: 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
Read the 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.
- Conditions
- Adults With Variability in Their Mood
- Being tested
- Transcranial alternating current stimulation (tACS), Neuro/biofeedback, Recall, Physiological stimulation
- Keywords
- mood-variability, brain stimulation, neurofeedback, Positive memory recall, Transcranial alternating current stimulation (tACS), electroencephaolography (EEG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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/biofeedbackBehavioural
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
RecallBehavioural
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 stimulationDevice
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Transcranial alternating current stimulation (tACS); Behavioral: Neuro/biofeedback; Behavioral: Recall; Device: Physiological stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2025
- Study start1 Jan 2026
- Primary completion1 Mar 2029 (estimated)
- Study completion1 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults With Variability in Their MoodStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Greg Siegle, University of Pittsburgh
- Investigators
- Greg Siegle, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07252011
- Sponsor's protocol ID
- STUDY25020073
- Acronym
- BandR
- Status last verified
- Mar 2026
- First submitted
- 18 Nov 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Restorative Neurophysiology: Feasibility of "Backup and Restore" Technologies for Brains and Bodies
- ClinicalTrials.gov ID
- NCT07252011
- Acronym / sponsor ID
- BandR / STUDY25020073
- Conditions
- Adults With Variability in Their Mood
- Keywords
- mood-variability, brain stimulation, neurofeedback, Positive memory recall, Transcranial alternating current stimulation (tACS), electroencephaolography (EEG)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Mar 2029 (estimated)
- Study completion
- 1 Mar 2029 (estimated)
- First posted
- 26 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study to examine the extent to which neurophysiological states recorded for a specific person on one day can be induced on a subsequent day
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recall + Stimulation + Neurofeedback | Experimental | Device: Transcranial alternating current stimulation (tACS), Behavioral: Neuro/biofeedback, Behavioral: Recall, Device: Physiological stimulationParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults age 18-65
- have periods of good and bad moods each lasting at least 2 days
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Recall + Stimulation + Neurofeedback |
| Neuro/biofeedbackParticipants 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 | Behavioural | Recall + Stimulation + Neurofeedback |
| RecallParticipants 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 | Behavioural | Recall + Stimulation + Neurofeedback |
| Physiological stimulationFacial electrical stimulation, and chest-worn vibroacoustic stimulation will be used to affect facial muscle activity and peripheral physiology to better approximate previously assessed states. | Device | Recall + Stimulation + Neurofeedback |
Primary outcome
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Greg Siegle principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial alternating current stimulation (tACS), Neuro/biofeedback and Recall in people with Adults With Variability in Their Mood, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Greg Siegle, PhD (412-864-3501, gsiegle@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in electroencephalogram (EEG) Activity Across 4 Frequency Bands from Baseline (time frame: 4 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.