Backing up and restoring your brain's mood states (BandR)
Restorative Neurophysiology: Feasibility of "Backup and Restore" Technologies for Brains and Bodies
This project tries to record a person's brain and body signals on a good day and then recreate that same state on a later bad day using personalized brain stimulation and neurofeedback for adults who experience mood swings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Pittsburgh Academic / other |
| Locations | 1 site (Pittsburgh, Pennsylvania) |
| Trial ID | NCT07252011 on ClinicalTrials.gov |
What this trial studies
This single-arm, longitudinal study collects subjective, physiological, and brain activity measures on three occasions spaced between about two weeks and four months. The first session is on a self-rated “good” day, the second on a self-rated “bad” day, and the third occurs within a week of the second. At sessions two and three, researchers use positive memory recall, neuro/biofeedback, and transcranial alternating current stimulation (tACS) to try to restore the earlier good-day brain state. Change in mood-related self-report, physiological reactivity, and brain measures will be compared across the sessions to determine how well personalized states can be re-induced.
Who should consider this trial
Good fit: Adults aged 18–65 who experience distinct periods of good and bad mood that last at least two days, can read English, and can avoid psychoactive substances during assessments are the best candidates.
Not a fit: People who are currently in frank psychosis, cannot stay off psychoactive substances, are in a manic state (for bipolar I), have chronic pain worsened by electrical stimulation, or have uncorrected vision or hearing problems are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, this approach could offer a personalized way to help people shift their brain state back toward a better mood when they are feeling low.
How similar studies have performed: Related work using tACS and neurofeedback has shown mixed but promising early results for modulating brain activity, while directly re-inducing personalized brain states across days is a relatively novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Pittsburgh, Pennsylvania
- University of Pittsburgh — Pittsburgh, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Greg Siegle — University of Pittsburgh
- Study coordinator: Greg Siegle, PhD
- Email: gsiegle@pitt.edu
- Phone: 412-864-3501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.