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

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

• Устройство 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.
• Поведенческое 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
• Поведенческое 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
• Устройство 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.

Первичные конечные точки

• Mean Change in electroencephalogram (EEG) Activity Across 4 Frequency Bands from Baseline [Срок оценки: 4 months]
• Mean Change in Happiness Visual Analogue Scale (VAS) Ratings From Baseline [Срок оценки: 4 months]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• University of Pittsburgh — Pittsburgh

Идентификаторы

NCT: NCT07252011 · STUDY25020073

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗